Ignite Creation Date:
2025-12-24 @ 9:35 PM
Ignite Modification Date:
2025-12-25 @ 7:18 PM
Study NCT ID:
NCT01354132
Status:
COMPLETED
Last Update Posted:
2017-07-05
First Post:
2011-05-13
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
N-Acetyl-Cysteine (NAC) in Early Phase Schizophrenia Spectrum Psychosis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000111', 'term': 'Acetylcysteine'}], 'ancestors': [{'id': 'D003545', 'term': 'Cysteine'}, {'id': 'D000603', 'term': 'Amino Acids, Sulfur'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'lseidman@bidmc.harvard.edu', 'phone': '617 754-1238', 'title': 'Larry Seidman, PhD', 'organization': 'Beth Israel Deaconess Medical Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Baseline and 6 months', 'description': 'Adverse Events were evaluated every month for 6 months and 1 month post treatment', 'eventGroups': [{'id': 'EG000', 'title': 'N-acetyl-cysteine', 'description': 'N-Acetyl cysteine effervescent tablets in water 2 in am and 1 in pm for 28 weeks\n\nn-acetylcysteine: 900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM', 'otherNumAtRisk': 31, 'deathsNumAtRisk': 31, 'otherNumAffected': 26, 'seriousNumAtRisk': 31, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'matching effervescent tablets in water 2 in am and 1 in pm\n\nn-acetylcysteine: 900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM', 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 29, 'seriousNumAtRisk': 30, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Tremor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 11}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Rigidity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 13}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Akathisia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 9}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dry Mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 15}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Increased Salivation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 8}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 5}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Emotional Indifference', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 21}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sedation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 21}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hair Loss', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 8}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Negative Symptoms of Schizophrenia as Measured on the PANSS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'N-acetyl-cysteine', 'description': 'N-Acetyl cysteine effervescent tablets in water 2 in am and 1 in pm for 28 weeks\n\nn-acetylcysteine: 900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'matching effervescent tablets in water 2 in am and 1 in pm\n\nn-acetylcysteine: 900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM'}], 'classes': [{'categories': [{'measurements': [{'value': '16.9', 'spread': '4.9', 'groupId': 'OG000'}, {'value': '17.2', 'spread': '5.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.50', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'at 6 months', 'description': 'Positive and Negative Symptom Scale was used to assess psychopathology. The sum of items N1 - N7 including N1) blunted affect, N2) emotional withdrawal, N3) poor rapport, N4) passive apathetic social withdrawal, N5) difficulty in abstract thinking, N6) lack of spontaneity and flow of conversation, and N7) sterotyped thinking were used to analyze negative symptoms of schizophrenia and were assessed for the previous week:\n\nRATING SCALE\n\n1: Absent 2: Minimal 3: Mild 4: Moderate 5: Moderate Severe 6: Severe 7: Extreme The higher the score the worse the symptoms. The lowest possible score is 7 and the highest possible score is 49 .', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was done with those who completed the 6 month treatment protocol.'}, {'type': 'SECONDARY', 'title': 'Change in Positive Symptoms (PANSS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'N-acetyl-cysteine', 'description': 'N-Acetyl cysteine effervescent tablets in water 2 in am and 1 in pm for 28 weeks\n\nn-acetylcysteine: 900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'matching effervescent tablets in water 2 in am and 1 in pm\n\nn-acetylcysteine: 900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM'}], 'classes': [{'categories': [{'measurements': [{'value': '13.7', 'spread': '7.8', 'groupId': 'OG000'}, {'value': '12.5', 'spread': '4.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.39', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'at 6 months', 'description': 'Positive and Negative Symptom Scale was used to assess psychopathology. The Positive symptom subscale of schizophrenia includes the sum of items P1 -P7 including P1) Delusions, P2) conceptual Disorganization, P3) Hallunicatory Behavior, P4) Excitement, P5) Grandiosity, P6) Suspiciousness and Persecution, and P7) Hostility and were assessed for the previous week:\n\nRATING SCALE\n\n1: Absent 2: Minimal 3: Mild 4: Moderate 5: Moderate Severe 6: Severe 7: Extreme The higher the score the worse the symptoms. The lowest possible score is 7 and the highest possible score is 49 .', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was done with participants who completed the 6 month treatment phase'}, {'type': 'SECONDARY', 'title': 'Global Assessment of Functioning (GAF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'N-acetyl-cysteine', 'description': 'N-Acetyl cysteine effervescent tablets in water 2 in am and 1 in pm for 28 weeks\n\nn-acetylcysteine: 900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'matching effervescent tablets in water 2 in am and 1 in pm\n\nn-acetylcysteine: 900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM'}], 'classes': [{'categories': [{'measurements': [{'value': '52.2', 'spread': '11.7', 'groupId': 'OG000'}, {'value': '53.8', 'spread': '11.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.52', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'at 6 months', 'description': 'Measure Description: Clinical Measure of Global level of Symptoms (Sx) and Functioning from 1 (Worst) to 100 (Best) in groups of 10:\n\n100 - 91: Superior functioning 90 - 81: Absent or minimal Sx 80 - 71: If symptoms are present and expected 70 - 61:Some mild Sx 60 - 51: Moderate Sx 50 - 41: Serious Sx 40 - 31: Some impairment in reality testing or communication 30 - 21: Behavior is considerably influenced by delusions or hallucinations 20 - 11: Some danger of hurting self or others 10 - 1: Persistent danger of severely hurting self or others', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Social and Occupational Functioning Assessment Scale (SOFAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'N-acetyl-cysteine', 'description': 'N-Acetyl cysteine effervescent tablets in water 2 in am and 1 in pm for 28 weeks\n\nn-acetylcysteine: 900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'matching effervescent tablets in water 2 in am and 1 in pm\n\nn-acetylcysteine: 900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM'}], 'classes': [{'categories': [{'measurements': [{'value': '54.6', 'spread': '11.3', 'groupId': 'OG000'}, {'value': '54.8', 'spread': '10.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.71', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'at 6 months', 'description': 'Measure of social and occupational functioning using the Social and Occupational Functioning Assessment Scale Measure Description: Rating of Overall Social and Occupational Functioning on a scale of 1 (worst) to 100 (best) in groups of 10:\n\n100-91: Superior functioning 90-81: Good functioning 80-71: Slight impairment 70-61: Some difficulty 60-51: Moderate difficulty 50-41: Serious impairment 40-31: Major impairment 30-21: Inability to function in almost all areas 20-11: Unable to function independently 10-1: Unable to function without harming self or others', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Cognition and Working Memory (MATRICS) Speed of Processing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'N-acetyl-cysteine', 'description': 'N-Acetyl cysteine effervescent tablets in water 2 in am and 1 in pm for 28 weeks\n\nn-acetylcysteine: 900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'matching effervescent tablets in water 2 in am and 1 in pm\n\nn-acetylcysteine: 900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM'}], 'classes': [{'categories': [{'measurements': [{'value': '41.47', 'spread': '11.45', 'groupId': 'OG000'}, {'value': '35.85', 'spread': '14.40', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.022', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Speed of Processing', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'at 6 months', 'description': 'The MATRICS is neurocognitive battery designed to assess cognition. Processing speed is a composite score including the following tests: Trail Making Test, BACS: Symbol Coding, Category Fluency: Animal Naming. The score is a standardized T-Score which indicates the number of standard deviations above or below the mean, a T-Score of 50, in 10 point increments. A T-Score of 60 indicates 1 standard deviation above the mean and a T-Score of 40 indicates 1 standard deviation below the mean. A score below 50 indicated cognitive processing below that of an age and gender matched healthy control population. A score above 50 indicates cognitive processing above that of an age and gender matched healthy control population.', 'unitOfMeasure': 'T- Scores', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis of cognitive data is based on those who completed the cognitive testing at 6 months which required a separate clinic appointment and thus the overall number of participants is lower due to a loss of that data from failure to keep the cognitive testing appointment.'}, {'type': 'SECONDARY', 'title': 'Change in Cognition and Working Memory (MATRICS) Working Memory', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'N-acetyl-cysteine', 'description': 'N-Acetyl cysteine effervescent tablets in water 2 in am and 1 in pm for 28 weeks\n\nn-acetylcysteine: 900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'matching effervescent tablets in water 2 in am and 1 in pm\n\nn-acetylcysteine: 900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM'}], 'classes': [{'categories': [{'measurements': [{'value': '47.47', 'spread': '9.61', 'groupId': 'OG000'}, {'value': '38.08', 'spread': '17.70', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.270', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'at 6 months', 'description': 'The MATRICS is neurocognitive battery designed to assess cognition. Working Memory score is a composite score based on the following sub-test WMS-III Spatial Span and Letter-Number Span. The score is a standardized T-Score which indicates the number of standard deviations above or below the mean, a T-Score of 50, in 10 point increments. A T-Score of 60 indicates 1 standard deviation above the mean and a T-Score of 40 indicates 1 standard deviation below the mean. A score below 50 indicated cognitive processing below that of an age and gender matched healthy control population. A score above 50 indicates cognitive processing above that of an age and gender matched healthy control population.', 'unitOfMeasure': 'T- Scores', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis of cognitive data is based on those who completed the cognitive testing at 6 months which required a separate clinic appointment and thus the overall number of participants is lower due to a loss of that data from failure to keep the cognitive testing appointment.'}, {'type': 'SECONDARY', 'title': 'Change in Cognition and Working Memory (MATRICS) Attention and Vigilance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'N-acetyl-cysteine', 'description': 'N-Acetyl cysteine effervescent tablets in water 2 in am and 1 in pm for 28 weeks\n\nn-acetylcysteine: 900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'matching effervescent tablets in water 2 in am and 1 in pm\n\nn-acetylcysteine: 900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM'}], 'classes': [{'categories': [{'measurements': [{'value': '40.92', 'spread': '12.98', 'groupId': 'OG000'}, {'value': '30.40', 'spread': '13.91', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.153', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'at 6 months', 'description': 'The MATRICS is neurocognitive battery designed to assess cognition. Sustained attention and Vigilance is a composite score based on the Continuous Performance Test -Identical Pairs. The score is a standardized T-Score which indicates the number of standard deviations above or below the mean, a T-Score of 50, in 10 point increments. A T-Score of 60 indicates 1 standard deviation above the mean and a T-Score of 40 indicates 1 standard deviation below the mean. A score below 50 indicated cognitive processing below that of an age and gender matched healthy control population. A score above 50 indicates cognitive processing above that of an age and gender matched healthy control population.', 'unitOfMeasure': 'T- Scores', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis of cognitive data is based on those who completed the cognitive testing at 6 months which required a separate clinic appointment and thus the overall number of participants is lower due to a loss of that data from failure to keep the cognitive testing appointment.'}, {'type': 'SECONDARY', 'title': 'Change in Cognition and Working Memory (MATRICS) Verbal Learning', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'N-acetyl-cysteine', 'description': 'N-Acetyl cysteine effervescent tablets in water 2 in am and 1 in pm for 28 weeks\n\nn-acetylcysteine: 900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'matching effervescent tablets in water 2 in am and 1 in pm\n\nn-acetylcysteine: 900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM'}], 'classes': [{'categories': [{'measurements': [{'value': '42.18', 'spread': '10.36', 'groupId': 'OG000'}, {'value': '44.62', 'spread': '12.34', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.876', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'at 6 months', 'description': 'The MATRICS is neurocognitive battery designed to assess cognition. Verbal Learning is a composite score based on the Hopkins Verbal Learning Test-Revised: Immediate Recall. The score is a standardized T-Score which indicates the number of standard deviations above or below the mean, a T-Score of 50, in 10 point increments. A T-Score of 60 indicates 1 standard deviation above the mean and a T-Score of 40 indicates 1 standard deviation below the mean. A score below 50 indicated cognitive processing below that of an age and gender matched healthy control population. A score above 50 indicates cognitive processing above that of an age and gender matched healthy control population.', 'unitOfMeasure': 'T- Scores', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis of cognitive data is based on those who completed the cognitive testing at 6 months which required a separate clinic appointment and thus the overall number of participants is lower due to a loss of that data from failure to keep the cognitive testing appointment.'}, {'type': 'SECONDARY', 'title': 'Change in Cognition and Working Memory (MATRICS) Visual Learning', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'N-acetyl-cysteine', 'description': 'N-Acetyl cysteine effervescent tablets in water 2 in am and 1 in pm for 28 weeks\n\nn-acetylcysteine: 900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'matching effervescent tablets in water 2 in am and 1 in pm\n\nn-acetylcysteine: 900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM'}], 'classes': [{'categories': [{'measurements': [{'value': '46.00', 'spread': '9.28', 'groupId': 'OG000'}, {'value': '47.75', 'spread': '19.12', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.464', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'at 6 months', 'description': 'The MATRICS is neurocognitive battery designed to assess cognition. Visual Learning is a composite score based on the Brief Visuospatial Memory test - Revised: Immediate Recall. The score is a standardized T-Score which indicates the number of standard deviations above or below the mean, a T-Score of 50, in 10 point increments. A T-Score of 60 indicates 1 standard deviation above the mean and a T-Score of 40 indicates 1 standard deviation below the mean. A score below 50 indicated cognitive processing below that of an age and gender matched healthy control population. A score above 50 indicates cognitive processing above that of an age and gender matched healthy control population.', 'unitOfMeasure': 'T- Scores', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis of cognitive data is based on those who completed the cognitive testing at 6 months which required a separate clinic appointment and thus the overall number of participants is lower due to a loss of that data from failure to keep the cognitive testing appointment.'}, {'type': 'SECONDARY', 'title': 'Change in Cognition and Working Memory (MATRICS) Reasoning and Problem Solving', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'N-acetyl-cysteine', 'description': 'N-Acetyl cysteine effervescent tablets in water 2 in am and 1 in pm for 28 weeks\n\nn-acetylcysteine: 900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'matching effervescent tablets in water 2 in am and 1 in pm\n\nn-acetylcysteine: 900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM'}], 'classes': [{'categories': [{'measurements': [{'value': '51.13', 'spread': '10.16', 'groupId': 'OG000'}, {'value': '44.38', 'spread': '12.80', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.741', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'at 6 months', 'description': 'The MATRICS is neurocognitive battery designed to assess cognition. Problem Solving is a composite score based on the NAB Mazes. The score is a standardized T-Score which indicates the number of standard deviations above or below the mean, a T-Score of 50, in 10 point increments. A T-Score of 60 indicates 1 standard deviation above the mean and a T-Score of 40 indicates 1 standard deviation below the mean. A score below 50 indicated cognitive processing below that of an age and gender matched healthy control population. A score above 50 indicates cognitive processing above that of an age and gender matched healthy control population.', 'unitOfMeasure': 'T- Scores', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis of cognitive data is based on those who completed the cognitive testing at 6 months which required a separate clinic appointment and thus the overall number of participants is lower due to a loss of that data from failure to keep the cognitive testing appointment.'}, {'type': 'SECONDARY', 'title': 'Change in Blood Level of Glutathione', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'N-acetyl-cysteine', 'description': 'N-Acetyl cysteine effervescent tablets in water 2 in am and 1 in pm for 28 weeks\n\nn-acetylcysteine: 900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'matching effervescent tablets in water 2 in am and 1 in pm\n\nn-acetylcysteine: 900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM'}], 'classes': [{'categories': [{'measurements': [{'value': '0.92', 'spread': '0.42', 'groupId': 'OG000'}, {'value': '0.82', 'spread': '0.19', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.05', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'at 6 months', 'description': 'Glutathione is a tripeptide comprised of three amino acids (cysteine, glutamic acid, and glycine) and acts as an antioxidant, a free radical scavanger and a detoxifying agent. Glutathione is an important co-factor for the enzyme glutathione peroxidase used in the uptake of amino acids. The level of glutathione is measured in blood cells.', 'unitOfMeasure': 'mM', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Blood Plasma Level of Cysteine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'N-acetyl-cysteine', 'description': 'N-Acetyl cysteine effervescent tablets in water 2 in am and 1 in pm for 28 weeks\n\nn-acetylcysteine: 900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'matching effervescent tablets in water 2 in am and 1 in pm\n\nn-acetylcysteine: 900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM'}], 'classes': [{'categories': [{'measurements': [{'value': '229.6', 'spread': '62.9', 'groupId': 'OG000'}, {'value': '246.5', 'spread': '42.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.33', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'at 6 months', 'description': 'Cysteine is an amino acid, a building block for proteins and is used throughout the body and was measured in blood plasma.', 'unitOfMeasure': 'uM', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'GPxbc Glutathione Peroxidase Activity in Blood Cells', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'N-acetyl-cysteine', 'description': 'N-Acetyl cysteine effervescent tablets in water 2 in am and 1 in pm for 28 weeks\n\nn-acetylcysteine: 900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'matching effervescent tablets in water 2 in am and 1 in pm\n\nn-acetylcysteine: 900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM'}], 'classes': [{'categories': [{'measurements': [{'value': '21.24', 'spread': '7.5', 'groupId': 'OG000'}, {'value': '21.01', 'spread': '6.93', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.90', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'at 6 months', 'description': 'GPxBC is a measurement of glutathiione peroxidase enzymatic activity in glutathione synthesis and the redox system in blood cells. Measured as umol/min/gHb from blood cells.', 'unitOfMeasure': 'umol/min/gHb', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Glutamine Brain Level for NAC Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'N-acetyl-cysteine', 'description': 'n-acetylcysteine: 900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM'}], 'classes': [{'categories': [{'measurements': [{'value': '3.16', 'spread': '0.56', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.6732', 'groupIds': ['OG000'], 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'at 6 months', 'description': 'Glutamine is measured in the medial prefrontal cortex using Magnetic Resonance Spectroscopy (H-MRS) and is a chemical that works to protect the brain from high levels of excitatory chemicals such as glutamate.', 'unitOfMeasure': 'mM', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of subjects in the NAC and Placebo group is lower as not everyone in the study agreed to a MRS, in addition the MRS was only done at the Switzerland site.'}, {'type': 'SECONDARY', 'title': 'Glutamine Brain Level for Placebo Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Group', 'description': 'Placebo comparison group for study matching effervescent tablets in water 2 in am and 1 in pm\n\nn-acetylcysteine: 900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM'}], 'classes': [{'categories': [{'measurements': [{'value': '2.90', 'spread': '0.46', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.8786', 'groupIds': ['OG000'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'at 6 months', 'description': 'Glutamine is measured in the medial prefrontal cortex using Magnetic Resonance Spectroscopy (H-MRS) and is a chemical that works to protect the brain from high levels of excitatory chemicals such as glutamate.', 'unitOfMeasure': 'mM', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of subjects in the NAC and Placebo group is lower as not everyone in the study agreed to a MRS, in addition the MRS was only done at the Switzerland site.'}, {'type': 'SECONDARY', 'title': 'Glutamate Brain Level for NAC Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'N-acetyl-cysteine', 'description': 'N-Acetyl cysteine effervescent tablets in water 2 in am and 1 in pm for 28 weeks\n\nn-acetylcysteine: 900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM'}], 'classes': [{'categories': [{'measurements': [{'value': '10.25', 'spread': '1.20', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.5622', 'groupIds': ['OG000'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'at 6 months', 'description': 'Brain marker, glutamate, was measured using Magnetic Resonance Spectroscopy (H-MRS) in the medial prefrontal cortex. Glutamate is an excitatory neurotransmitter in the brain.', 'unitOfMeasure': 'mM', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of subjects in the NAC and Placebo group is lower as not everyone in the study agreed to a MRS, in addition the MRS was only done at the Switzerland site.'}, {'type': 'SECONDARY', 'title': 'Glutamate Brain Level for Placebo Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Group', 'description': 'Placebo comparison group for study matching effervescent placebo tablets in water 2 in am and 1 in pm'}], 'classes': [{'categories': [{'measurements': [{'value': '10.65', 'spread': '1.26', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.9574', 'groupIds': ['OG000'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'at 6 months', 'description': 'Glutamine is measured in the medial prefrontal cortex using Magnetic Resonance Spectroscopy (H-MRS) and is a chemical that works to protect the brain from high levels of excitatory chemicals such as glutamate.', 'unitOfMeasure': 'mM', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of subjects in the NAC and Placebo group is lower as not everyone in the study agreed to a MRS, in addition the MRS was only done at the Switzerland site.'}, {'type': 'SECONDARY', 'title': 'Glutathione Brain Level for NAC Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'N-acetyl-cysteine', 'description': 'N-Acetyl cysteine effervescent tablets in water 2 in am and 1 in pm for 28 weeks\n\nn-acetylcysteine: 900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM'}], 'classes': [{'categories': [{'measurements': [{'value': '1.04', 'spread': '0.27', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.0043', 'groupIds': ['OG000'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'at 6 months', 'description': 'measured by H-MRS in the medial prefrontal cortex Brain markers, glutathione was measured using Magnetic Resonance Spectroscopy (H-MRS) in the medial prefrontal cortex. Glutathione is a tripeptide comprised of three amino acids (cysteine, glutamic acid, and glycine) and acts as an antioxidant, a free radical scavanger and a detoxifying agent. Glutathione is an important co-factor for the enzyme glutathione peroxidase used in the uptake of amino acids.', 'unitOfMeasure': 'mM', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of subjects in the NAC and Placebo group is lower as not everyone in the study agreed to a MRS, in addition the MRS was only done at the Switzerland site.'}, {'type': 'SECONDARY', 'title': 'Glutathione Brain Level for Placebo Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Group', 'description': 'Placebo comparison group for study matching effervescent placebo tablets in water 2 in am and 1 in pm'}], 'classes': [{'categories': [{'measurements': [{'value': '1.05', 'spread': '0.20', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.3804', 'groupIds': ['OG000'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'at 6 months', 'description': 'measured by H-MRS in the medial prefrontal cortex Brain markers, glutathione was measured using Magnetic Resonance Spectroscopy (H-MRS) in the medial prefrontal cortex. Glutathione is a tripeptide comprised of three amino acids (cysteine, glutamic acid, and glycine) and acts as an antioxidant, a free radical scavanger and a detoxifying agent. Glutathione is an important co-factor for the enzyme glutathione peroxidase used in the uptake of amino acids.', 'unitOfMeasure': 'mM', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of subjects in the NAC and Placebo group is lower as not everyone in the study agreed to a MRS, in addition the MRS was only done at the Switzerland site.'}, {'type': 'SECONDARY', 'title': 'Myo-Inositol Brain Level for the NAC Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'N-acetyl-cysteine', 'description': 'N-Acetyl cysteine effervescent tablets in water 2 in am and 1 in pm for 28 weeks\n\nn-acetylcysteine: 900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM'}], 'classes': [{'categories': [{'measurements': [{'value': '6.27', 'spread': '1.07', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.9403', 'groupIds': ['OG000'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'at 6 months', 'description': 'Myo-Inositol is measured in the medial prefrontal cortex using Magnetic Resonance Spectroscopy (H-MRS)MRS and is a chemical that works to protect the brain from high levels of excitatory chemicals such as glutamate.', 'unitOfMeasure': 'mM', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of subjects in the NAC and Placebo group is lower as not everyone in the study agreed to a MRS, in addition the MRS was only done at the Switzerland site.'}, {'type': 'SECONDARY', 'title': 'Myo-Inositol Brain Level for Placebo Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Group', 'description': 'Placebo comparison group for study matching effervescent placebo tablets in water 2 in am and 1 in pm'}], 'classes': [{'categories': [{'measurements': [{'value': '6.26', 'spread': '1.05', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.9215', 'groupIds': ['OG000'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'at 6 months', 'description': 'Myo-Inositol is measured in the medial prefrontal cortex using Magnetic Resonance Spectroscopy (H-MRS)MRS and is a chemical that works to protect the brain from high levels of excitatory chemicals such as glutamate.', 'unitOfMeasure': 'mM', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of subjects in the NAC and Placebo group is lower as not everyone in the study agreed to a MRS, in addition the MRS was only done at the Switzerland site.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'N-acetyl-cysteine', 'description': 'N-Acetyl cysteine effervescent tablets in water 2 in am and 1 in pm for 28 weeks\n\nn-acetylcysteine: 900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'matching effervescent tablets in water 2 in am and 1 in pm\n\nn-acetylcysteine: 900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM'}], 'periods': [{'title': 'Randomization', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': '1 never took study medication dropped by physician decision (White matter lesion on MRI)', 'groupId': 'FG000', 'numSubjects': '32'}, {'comment': '1 never took study medication due to subject withdrawal', 'groupId': 'FG001', 'numSubjects': '31'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}, {'groupId': 'FG001', 'numSubjects': '30'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}, {'title': 'Double Blind (Visits 1-7)', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': '9 did not compete 7 study visits', 'groupId': 'FG000', 'numSubjects': '31'}, {'comment': '11 did not compete 7 study visits', 'groupId': 'FG001', 'numSubjects': '30'}]}, {'type': 'Completed More Than 1 Visit', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Stopped After First Visit', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': "Didn't Complete at Least 1 Visit", 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '19'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '11'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '11'}]}]}, {'title': '1 Month Post Study Medication', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '19'}]}, {'type': '1 Follow-up Visit (Visit 8)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}], 'recruitmentDetails': 'Participants were recruited at two sites, Lausanne University Hospital, Department of Psychiatry, Lausanne, Switzerland and at the Commonwealth Research Center of Beth Israel Deaconess Medical Center Boston, Massachusetts', 'preAssignmentDetails': '320 signed consent 133 declined to participate 124 excluded - 65 by Physician decision, 59 subject withdrew 63 met all inclusion and no exclusion criteria 31 to NAC and 30 to placebo'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'N-acetyl-cysteine', 'description': 'N-Acetyl cysteine effervescent tablets in water 2 in am and 1 in pm for 28 weeks\n\nn-acetylcysteine: 900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'matching effervescent tablets in water 2 in am and 1 in pm\n\nn-acetylcysteine: 900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '26.1', 'spread': '6.1', 'groupId': 'BG000'}, {'value': '24.7', 'spread': '5.9', 'groupId': 'BG001'}, {'value': '25.4', 'spread': '6.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Black or African American', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}, {'title': 'White', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}]}, {'title': 'Maghreb', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Hispanic or Latino', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Not Hispanic or Latino', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}, {'title': 'Switzerland', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Positive and Negative Symptom Scale (PANSS)', 'classes': [{'title': 'Positive PANSS Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '14.3', 'spread': '5.4', 'groupId': 'BG000'}, {'value': '15.0', 'spread': '5.6', 'groupId': 'BG001'}, {'value': '14.7', 'spread': '16.4', 'groupId': 'BG002'}]}]}, {'title': 'Negative Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '15.6', 'spread': '5.0', 'groupId': 'BG000'}, {'value': '17.3', 'spread': '6.3', 'groupId': 'BG001'}, {'value': '16.4', 'spread': '5.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Clinical Measure of Positive (7 items P1-P7) Negative Symptoms (7 items N1-N7) General Psychopathology Symptoms (G1-G16) total of 30 items\n\nAssessed in the previous week:\n\nRATING SCALE\n\n1: Absent 2: Minimal 3: Mild 4: Moderate 5: Moderate Severe 6: Severe 7: Extreme The higher the score the worse the symptoms. The lowest possible score is 30 and the highesr possible score is 210.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Global Assessment of Functioning (GAF)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '54', 'spread': '10.8', 'groupId': 'BG000'}, {'value': '51.6', 'spread': '12.8', 'groupId': 'BG001'}, {'value': '52.8', 'spread': '11.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Clinical Measure of Global level of Symptoms (Sx) and Functioning from 1 (Worst) to 100 (Best) in groups of 10:\n\n100 - 91: Superior functioning 90 - 81: Absent or minimal Sx 80 - 71: If symptoms are present and expected 70 - 61:Some mild Sx 60 - 51: Moderate Sx 50 - 41: Serious Sx 40 - 31: Some impairment in reality testing or communication 30 - 21: Behavior is considerably influenced by delusions or hallucinations 20 - 11: Some danger of hurting self or others 10 - 1: Persistent danger of severely hurting self or others', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Duration of Psychosis', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '848', 'spread': '767', 'groupId': 'BG000'}, {'value': '747', 'spread': '693', 'groupId': 'BG001'}, {'value': '796', 'spread': '726', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Duration of time in days since onset of psychosis', 'unitOfMeasure': 'days', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Social and Occupational Functioning Assessment Scale (SOFAS)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '55.8', 'spread': '11.0', 'groupId': 'BG000'}, {'value': '53.5', 'spread': '13.0', 'groupId': 'BG001'}, {'value': '54.7', 'spread': '12.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Rating of Overall Social and Occupational Functioning on a scale of 1 (worst) to 100 (best) in groups of 10:\n\n100-91: Superior functioning 90-81: Good functioning 80-71: Slight impairment 70-61: Some difficulty 60-51: Moderate difficulty 50-41: Serious impairment 40-31: Major impairment 30-21: Inability to function in almost all areas 20-11: Unable to function independently 10-1: Unable to function without harming self or others', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'MATRICS Consensus Cognitive Battery (MCCB) excluding MISCEIT managing emotions test)', 'classes': [{'title': 'Processing Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '37.72', 'spread': '11.22', 'groupId': 'BG000'}, {'value': '35.53', 'spread': '16.31', 'groupId': 'BG001'}, {'value': '36.75', 'spread': '13.48', 'groupId': 'BG002'}]}]}, {'title': 'Sustained Attention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '40.23', 'spread': '11.71', 'groupId': 'BG000'}, {'value': '32.67', 'spread': '13.15', 'groupId': 'BG001'}, {'value': '36.87', 'spread': '12.35', 'groupId': 'BG002'}]}]}, {'title': 'Working Memory', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '47.56', 'spread': '9.70', 'groupId': 'BG000'}, {'value': '38.87', 'spread': '15.09', 'groupId': 'BG001'}, {'value': '43.70', 'spread': '12.10', 'groupId': 'BG002'}]}]}, {'title': 'Verbal Learning', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '40.94', 'spread': '10.09', 'groupId': 'BG000'}, {'value': '40.93', 'spread': '13.73', 'groupId': 'BG001'}, {'value': '40.94', 'spread': '11.71', 'groupId': 'BG002'}]}]}, {'title': 'Visual Learning', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '41.06', 'spread': '10.01', 'groupId': 'BG000'}, {'value': '44.86', 'spread': '14.42', 'groupId': 'BG001'}, {'value': '42.75', 'spread': '11.97', 'groupId': 'BG002'}]}]}, {'title': 'Problem Solving', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '48.00', 'spread': '11.69', 'groupId': 'BG000'}, {'value': '39.93', 'spread': '12.76', 'groupId': 'BG001'}, {'value': '44.41', 'spread': '12.17', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The MCCB has 6 cognitive factors including: 1) processing speed (Trail Making Test, BACS: Symbol Coding, Category Fluency: Animal Naming), 2) sustained attention (Continuous Performance Test -Identical Pairs), 3) working memory (WMS-III Spatial Span and Letter-Number Span), 4) verbal learning (Hopkins Verbal Learning Test-Revised: Immediate Recall), 5) visual learning (Brief Visuospatial Memory test - Revised: Immediate Recall) and 6) problem solving (NAB Mazes). The T-score of 50 is an average score. Scores below 50 indicates cognitive processing lower than age matched healthy populations.', 'unitOfMeasure': 'Standardized T Scores', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Numbers in each group analyzed based on those who completed baseline and post testing.'}, {'title': 'Antipsychotic Medication Chlorpromazine Equivalents', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '309', 'spread': '252', 'groupId': 'BG000'}, {'value': '309', 'spread': '188', 'groupId': 'BG001'}, {'value': '309', 'spread': '220', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Dose of current antipsychotic medication in chlorpromazine equivalents', 'unitOfMeasure': 'milligrams', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Blood Marker - Cysteine', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '261.3', 'spread': '37.6', 'groupId': 'BG000'}, {'value': '254.0', 'spread': '33.6', 'groupId': 'BG001'}, {'value': '257.7', 'spread': '35.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Cysteine is an amino acid, a building block for proteins and is used throughout the body and was measured in blood plasma.', 'unitOfMeasure': 'uM (micrometer)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Blood Marker - GPxbc- Glutathione peroxidase', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '21.24', 'spread': '7.5', 'groupId': 'BG000'}, {'value': '21.01', 'spread': '6.93', 'groupId': 'BG001'}, {'value': '21.13', 'spread': '7.17', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'GPxBC is a measurement of glutathiione peroxidase enzymatic activity in glutathione synthesis and the redox system in blood cells. Measured as umol/min/gHb from blood cells.', 'unitOfMeasure': 'umol/min/gHb', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Blood Marker - Glutathione', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0.77', 'spread': '0.21', 'groupId': 'BG000'}, {'value': '0.84', 'spread': '0.27', 'groupId': 'BG001'}, {'value': '0.81', 'spread': '0.24', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Glutathione is a tripeptide comprised of three amino acids (cysteine, glutamic acid, and glycine) and acts as an antioxidant, a free radical scavanger and a detoxifying agent. Glutathione is an important co-factor for the enzyme glutathione peroxidase used in the uptake of amino acids. The level of glutathione is measured in blood cells.', 'unitOfMeasure': 'mM (millimolar) in blood cells', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Brain Marker - Glutamine and myo-Inositol', 'classes': [{'title': 'Glutamine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '3.25', 'spread': '0.51', 'groupId': 'BG000'}, {'value': '2.93', 'spread': '0.48', 'groupId': 'BG001'}, {'value': '3.10', 'spread': '0.50', 'groupId': 'BG002'}]}]}, {'title': 'Myo-Inositol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '6.25', 'spread': '1.05', 'groupId': 'BG000'}, {'value': '6.28', 'spread': '0.62', 'groupId': 'BG001'}, {'value': '6.26', 'spread': '0.84', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Brain levels of glutamine and myo-Inositol were measured using Magnetic ResonanceSpectroscopy (H-MRS), both are chemicals that work to protect the brain from high levels of excitatory chemicals such as glutamate.', 'unitOfMeasure': 'mM (millimolar)', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'MRS was completed on fewer participants.'}, {'title': 'Brain Marker - Glutathione and Glutamate', 'classes': [{'title': 'Glutathione', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0.87', 'spread': '0.23', 'groupId': 'BG000'}, {'value': '1.12', 'spread': '0.18', 'groupId': 'BG001'}, {'value': '0.99', 'spread': '0.21', 'groupId': 'BG002'}]}]}, {'title': 'Glutamate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '10.12', 'spread': '0.80', 'groupId': 'BG000'}, {'value': '10.64', 'spread': '1.23', 'groupId': 'BG001'}, {'value': '10.37', 'spread': '1.01', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Brain markers, glutathione and glutamate were measured using Magnetic Resonance Spectroscopy (H-MRS) in the medial prefrontal cortex. Glutathione is a tripeptide comprised of three amino acids (cysteine, glutamic acid, and glycine) and acts as an antioxidant, a free radical scavanger and a detoxifying agent. Glutathione is an important co-factor for the enzyme glutathione peroxidase used in the uptake of amino acids. Glutamate is an excitatory neurotransmitter in the brain.', 'unitOfMeasure': 'mM (millimolar)', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Only 25 participants had the MRS.'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-06-13', 'studyFirstSubmitDate': '2011-05-13', 'resultsFirstSubmitDate': '2017-03-17', 'studyFirstSubmitQcDate': '2011-05-13', 'lastUpdatePostDateStruct': {'date': '2017-07-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-05-09', 'studyFirstPostDateStruct': {'date': '2011-05-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-06-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Negative Symptoms of Schizophrenia as Measured on the PANSS', 'timeFrame': 'at 6 months', 'description': 'Positive and Negative Symptom Scale was used to assess psychopathology. The sum of items N1 - N7 including N1) blunted affect, N2) emotional withdrawal, N3) poor rapport, N4) passive apathetic social withdrawal, N5) difficulty in abstract thinking, N6) lack of spontaneity and flow of conversation, and N7) sterotyped thinking were used to analyze negative symptoms of schizophrenia and were assessed for the previous week:\n\nRATING SCALE\n\n1: Absent 2: Minimal 3: Mild 4: Moderate 5: Moderate Severe 6: Severe 7: Extreme The higher the score the worse the symptoms. The lowest possible score is 7 and the highest possible score is 49 .'}], 'secondaryOutcomes': [{'measure': 'Change in Positive Symptoms (PANSS)', 'timeFrame': 'at 6 months', 'description': 'Positive and Negative Symptom Scale was used to assess psychopathology. The Positive symptom subscale of schizophrenia includes the sum of items P1 -P7 including P1) Delusions, P2) conceptual Disorganization, P3) Hallunicatory Behavior, P4) Excitement, P5) Grandiosity, P6) Suspiciousness and Persecution, and P7) Hostility and were assessed for the previous week:\n\nRATING SCALE\n\n1: Absent 2: Minimal 3: Mild 4: Moderate 5: Moderate Severe 6: Severe 7: Extreme The higher the score the worse the symptoms. The lowest possible score is 7 and the highest possible score is 49 .'}, {'measure': 'Global Assessment of Functioning (GAF)', 'timeFrame': 'at 6 months', 'description': 'Measure Description: Clinical Measure of Global level of Symptoms (Sx) and Functioning from 1 (Worst) to 100 (Best) in groups of 10:\n\n100 - 91: Superior functioning 90 - 81: Absent or minimal Sx 80 - 71: If symptoms are present and expected 70 - 61:Some mild Sx 60 - 51: Moderate Sx 50 - 41: Serious Sx 40 - 31: Some impairment in reality testing or communication 30 - 21: Behavior is considerably influenced by delusions or hallucinations 20 - 11: Some danger of hurting self or others 10 - 1: Persistent danger of severely hurting self or others'}, {'measure': 'Social and Occupational Functioning Assessment Scale (SOFAS)', 'timeFrame': 'at 6 months', 'description': 'Measure of social and occupational functioning using the Social and Occupational Functioning Assessment Scale Measure Description: Rating of Overall Social and Occupational Functioning on a scale of 1 (worst) to 100 (best) in groups of 10:\n\n100-91: Superior functioning 90-81: Good functioning 80-71: Slight impairment 70-61: Some difficulty 60-51: Moderate difficulty 50-41: Serious impairment 40-31: Major impairment 30-21: Inability to function in almost all areas 20-11: Unable to function independently 10-1: Unable to function without harming self or others'}, {'measure': 'Change in Cognition and Working Memory (MATRICS) Speed of Processing', 'timeFrame': 'at 6 months', 'description': 'The MATRICS is neurocognitive battery designed to assess cognition. Processing speed is a composite score including the following tests: Trail Making Test, BACS: Symbol Coding, Category Fluency: Animal Naming. The score is a standardized T-Score which indicates the number of standard deviations above or below the mean, a T-Score of 50, in 10 point increments. A T-Score of 60 indicates 1 standard deviation above the mean and a T-Score of 40 indicates 1 standard deviation below the mean. A score below 50 indicated cognitive processing below that of an age and gender matched healthy control population. A score above 50 indicates cognitive processing above that of an age and gender matched healthy control population.'}, {'measure': 'Change in Cognition and Working Memory (MATRICS) Working Memory', 'timeFrame': 'at 6 months', 'description': 'The MATRICS is neurocognitive battery designed to assess cognition. Working Memory score is a composite score based on the following sub-test WMS-III Spatial Span and Letter-Number Span. The score is a standardized T-Score which indicates the number of standard deviations above or below the mean, a T-Score of 50, in 10 point increments. A T-Score of 60 indicates 1 standard deviation above the mean and a T-Score of 40 indicates 1 standard deviation below the mean. A score below 50 indicated cognitive processing below that of an age and gender matched healthy control population. A score above 50 indicates cognitive processing above that of an age and gender matched healthy control population.'}, {'measure': 'Change in Cognition and Working Memory (MATRICS) Attention and Vigilance', 'timeFrame': 'at 6 months', 'description': 'The MATRICS is neurocognitive battery designed to assess cognition. Sustained attention and Vigilance is a composite score based on the Continuous Performance Test -Identical Pairs. The score is a standardized T-Score which indicates the number of standard deviations above or below the mean, a T-Score of 50, in 10 point increments. A T-Score of 60 indicates 1 standard deviation above the mean and a T-Score of 40 indicates 1 standard deviation below the mean. A score below 50 indicated cognitive processing below that of an age and gender matched healthy control population. A score above 50 indicates cognitive processing above that of an age and gender matched healthy control population.'}, {'measure': 'Change in Cognition and Working Memory (MATRICS) Verbal Learning', 'timeFrame': 'at 6 months', 'description': 'The MATRICS is neurocognitive battery designed to assess cognition. Verbal Learning is a composite score based on the Hopkins Verbal Learning Test-Revised: Immediate Recall. The score is a standardized T-Score which indicates the number of standard deviations above or below the mean, a T-Score of 50, in 10 point increments. A T-Score of 60 indicates 1 standard deviation above the mean and a T-Score of 40 indicates 1 standard deviation below the mean. A score below 50 indicated cognitive processing below that of an age and gender matched healthy control population. A score above 50 indicates cognitive processing above that of an age and gender matched healthy control population.'}, {'measure': 'Change in Cognition and Working Memory (MATRICS) Visual Learning', 'timeFrame': 'at 6 months', 'description': 'The MATRICS is neurocognitive battery designed to assess cognition. Visual Learning is a composite score based on the Brief Visuospatial Memory test - Revised: Immediate Recall. The score is a standardized T-Score which indicates the number of standard deviations above or below the mean, a T-Score of 50, in 10 point increments. A T-Score of 60 indicates 1 standard deviation above the mean and a T-Score of 40 indicates 1 standard deviation below the mean. A score below 50 indicated cognitive processing below that of an age and gender matched healthy control population. A score above 50 indicates cognitive processing above that of an age and gender matched healthy control population.'}, {'measure': 'Change in Cognition and Working Memory (MATRICS) Reasoning and Problem Solving', 'timeFrame': 'at 6 months', 'description': 'The MATRICS is neurocognitive battery designed to assess cognition. Problem Solving is a composite score based on the NAB Mazes. The score is a standardized T-Score which indicates the number of standard deviations above or below the mean, a T-Score of 50, in 10 point increments. A T-Score of 60 indicates 1 standard deviation above the mean and a T-Score of 40 indicates 1 standard deviation below the mean. A score below 50 indicated cognitive processing below that of an age and gender matched healthy control population. A score above 50 indicates cognitive processing above that of an age and gender matched healthy control population.'}, {'measure': 'Change in Blood Level of Glutathione', 'timeFrame': 'at 6 months', 'description': 'Glutathione is a tripeptide comprised of three amino acids (cysteine, glutamic acid, and glycine) and acts as an antioxidant, a free radical scavanger and a detoxifying agent. Glutathione is an important co-factor for the enzyme glutathione peroxidase used in the uptake of amino acids. The level of glutathione is measured in blood cells.'}, {'measure': 'Blood Plasma Level of Cysteine', 'timeFrame': 'at 6 months', 'description': 'Cysteine is an amino acid, a building block for proteins and is used throughout the body and was measured in blood plasma.'}, {'measure': 'GPxbc Glutathione Peroxidase Activity in Blood Cells', 'timeFrame': 'at 6 months', 'description': 'GPxBC is a measurement of glutathiione peroxidase enzymatic activity in glutathione synthesis and the redox system in blood cells. Measured as umol/min/gHb from blood cells.'}, {'measure': 'Glutamine Brain Level for NAC Group', 'timeFrame': 'at 6 months', 'description': 'Glutamine is measured in the medial prefrontal cortex using Magnetic Resonance Spectroscopy (H-MRS) and is a chemical that works to protect the brain from high levels of excitatory chemicals such as glutamate.'}, {'measure': 'Glutamine Brain Level for Placebo Group', 'timeFrame': 'at 6 months', 'description': 'Glutamine is measured in the medial prefrontal cortex using Magnetic Resonance Spectroscopy (H-MRS) and is a chemical that works to protect the brain from high levels of excitatory chemicals such as glutamate.'}, {'measure': 'Glutamate Brain Level for NAC Group', 'timeFrame': 'at 6 months', 'description': 'Brain marker, glutamate, was measured using Magnetic Resonance Spectroscopy (H-MRS) in the medial prefrontal cortex. Glutamate is an excitatory neurotransmitter in the brain.'}, {'measure': 'Glutamate Brain Level for Placebo Group', 'timeFrame': 'at 6 months', 'description': 'Glutamine is measured in the medial prefrontal cortex using Magnetic Resonance Spectroscopy (H-MRS) and is a chemical that works to protect the brain from high levels of excitatory chemicals such as glutamate.'}, {'measure': 'Glutathione Brain Level for NAC Group', 'timeFrame': 'at 6 months', 'description': 'measured by H-MRS in the medial prefrontal cortex Brain markers, glutathione was measured using Magnetic Resonance Spectroscopy (H-MRS) in the medial prefrontal cortex. Glutathione is a tripeptide comprised of three amino acids (cysteine, glutamic acid, and glycine) and acts as an antioxidant, a free radical scavanger and a detoxifying agent. Glutathione is an important co-factor for the enzyme glutathione peroxidase used in the uptake of amino acids.'}, {'measure': 'Glutathione Brain Level for Placebo Group', 'timeFrame': 'at 6 months', 'description': 'measured by H-MRS in the medial prefrontal cortex Brain markers, glutathione was measured using Magnetic Resonance Spectroscopy (H-MRS) in the medial prefrontal cortex. Glutathione is a tripeptide comprised of three amino acids (cysteine, glutamic acid, and glycine) and acts as an antioxidant, a free radical scavanger and a detoxifying agent. Glutathione is an important co-factor for the enzyme glutathione peroxidase used in the uptake of amino acids.'}, {'measure': 'Myo-Inositol Brain Level for the NAC Group', 'timeFrame': 'at 6 months', 'description': 'Myo-Inositol is measured in the medial prefrontal cortex using Magnetic Resonance Spectroscopy (H-MRS)MRS and is a chemical that works to protect the brain from high levels of excitatory chemicals such as glutamate.'}, {'measure': 'Myo-Inositol Brain Level for Placebo Group', 'timeFrame': 'at 6 months', 'description': 'Myo-Inositol is measured in the medial prefrontal cortex using Magnetic Resonance Spectroscopy (H-MRS)MRS and is a chemical that works to protect the brain from high levels of excitatory chemicals such as glutamate.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['schizophrenia', 'schizoaffective', 'schizophreniform', 'early schizophrenia spectrum psychosis'], 'conditions': ['Schizophrenic Psychoses']}, 'referencesModule': {'references': [{'pmid': '20436260', 'type': 'BACKGROUND', 'citation': 'Do KQ, Conus P, Cuenod M. Redox dysregulation and oxidative stress in schizophrenia: nutrigenetics as a challenge in psychiatric disease prevention. World Rev Nutr Diet. 2010;101:131-153. doi: 10.1159/000314518. Epub 2010 Apr 30. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'The investigators seek to examine the effect of add-on N-Acetyl-Cysteine (NAC) in the early phase of schizophrenia spectrum illness in collaboration with researchers Kim Do, PhD, and Philippe Conus, MD in Switzerland. Modifications of brain structure are thought to occur during the pre-illness phase and around the transition to psychosis. Therefore, studying new treatments that could target changes occurring during this period is of critical importance.\n\nAims:\n\nDoes add-on NAC treatment in early psychosis influence:\n\n* positive and negative symptoms\n* extrapyramidal side-effects of other medication\n* plasma concentration of glutathione\n* Mismatch Negativity, a physiological marker', 'detailedDescription': 'The study proposes that a glutathione deficit leading to an abnormal response to oxidative stress is a vulnerability factor, combined with other brain specific factors, in brain functioning of some individuals with schizophrenia (Do et al., 2010). N-acetyl-cysteine is hypothesized to cross the blood-brain barrier and increase glutathione in the brain.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Capacity to provide informed consent\n* DSM IV TR diagnosis of schizophrenia, schizophreniform, schizoaffective\n* Psychiatric and medical stability\n* Prescribing clinician's premission to participate, assurance of medical stability\n* Having met threshold criteria for psychosis on CAARMS (Comprehensive Assessment of at Risk Mental States Scale) Psychosis subscale\n* Up to 12 months of antipsychotic treatment\n\nExclusion Criteria:\n\n* Severe medical comorbidities\n* Previous cerebral trauma\n* Substance induced psychosis or organic psychosis\n* Mental retardation\n* NAC allergy\n* Pregnancy, females and males planning pregnancy\n* Treatment with antioxidants\n* Insufficient command of English"}, 'identificationModule': {'nctId': 'NCT01354132', 'acronym': 'NACPSY', 'briefTitle': 'N-Acetyl-Cysteine (NAC) in Early Phase Schizophrenia Spectrum Psychosis', 'organization': {'class': 'OTHER', 'fullName': 'Beth Israel Deaconess Medical Center'}, 'officialTitle': 'Effects of Oral N-Acetyl-Cysteine (NAC) in the Early Phase of Schizophrenia Spectrum Psychosis: Randomized, Parallel, Double- Blind, Placebo Controlled Trial', 'orgStudyIdInfo': {'id': '2008P000460'}, 'secondaryIdInfos': [{'id': '107865', 'type': 'OTHER', 'domain': 'FDA IND'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'n-acetyl-cysteine', 'description': 'N-Acetyl cysteine effervescent tablets in water 2 in am and 1 in pm for 28 weeks', 'interventionNames': ['Drug: n-acetylcysteine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'matching effervescent tablets in water 2 in am and 1 in pm', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'n-acetylcysteine', 'type': 'DRUG', 'otherNames': ['PharmaNAC'], 'description': '900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM', 'armGroupLabels': ['n-acetyl-cysteine']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo tablets are placed in water or juice in the AM and PM', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Beth Israel Deaconess Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts Mental Health Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Ann Cousins, PhD, APRN', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Beth Israel Deaconess Medical Center'}, {'name': 'T. U. Wilson Woo, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Harvard Medical School (HMS and HSDM)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beth Israel Deaconess Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Center de Neurosciences Psychiatrique, Lausanne, Switzerland', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Larry Seidman', 'investigatorAffiliation': 'Beth Israel Deaconess Medical Center'}}}}