Ignite Creation Date:
2025-12-24 @ 10:35 PM
Ignite Modification Date:
2025-12-25 @ 8:07 PM
Study NCT ID:
NCT00222235
Status:
COMPLETED
Last Update Posted:
2019-08-20
First Post:
2005-09-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Adjunctive Treatment for Decreasing Symptoms of Schizophrenia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}, {'id': 'D011618', 'term': 'Psychotic Disorders'}, {'id': 'D060825', 'term': 'Cognitive Dysfunction'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003523', 'term': 'Cycloserine'}, {'id': 'D005998', 'term': 'Glycine'}], 'ancestors': [{'id': 'D007555', 'term': 'Isoxazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D023303', 'term': 'Oxazolidinones'}, {'id': 'D010080', 'term': 'Oxazoles'}, {'id': 'D012694', 'term': 'Serine'}, {'id': 'D021542', 'term': 'Amino Acids, Neutral'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 240}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-01', 'type': 'ACTUAL'}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2004-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-15', 'studyFirstSubmitDate': '2005-09-13', 'studyFirstSubmitQcDate': '2005-09-14', 'lastUpdatePostDateStruct': {'date': '2019-08-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2005-09-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'changes from baseline in negative symptoms measured on SANS at 4,8,12 and 16 weeks.'}, {'measure': 'change from baseline on neurocognitive battery measured at 16 weeks.'}], 'secondaryOutcomes': [{'measure': 'change in psychotic and depressive symptoms measured at 4,8,12, and 16 weeks.'}, {'measure': 'changes in extrapyramidal side effects at 4,8,12 and 16 weeks.'}]}, 'conditionsModule': {'keywords': ['schizophrenia', 'schizoaffective disorder', 'negative symptoms', 'cognitive impairments'], 'conditions': ['Schizophrenia', 'Schizoaffective Disorder']}, 'referencesModule': {'references': [{'pmid': '17898352', 'type': 'DERIVED', 'citation': 'Buchanan RW, Javitt DC, Marder SR, Schooler NR, Gold JM, McMahon RP, Heresco-Levy U, Carpenter WT. The Cognitive and Negative Symptoms in Schizophrenia Trial (CONSIST): the efficacy of glutamatergic agents for negative symptoms and cognitive impairments. Am J Psychiatry. 2007 Oct;164(10):1593-602. doi: 10.1176/appi.ajp.2007.06081358.'}]}, 'descriptionModule': {'briefSummary': 'This study will determine the effectiveness of treatment with glycine or d-cycloserine in addition to a normal antipsychotic regimen in improving negative symptoms and cognitive impairments in patients with schizophrenia.', 'detailedDescription': 'A double-blind, placebo controlled clinical trial to examine whether adjunctive treatment with glycine or d-cycloserine, compared to placebo, will improve negative symptoms and cognitive impairments in patients with schizophrenia who remain on their normal antipsychotic regimen.\n\nMulticenter, randomized, double-blinded placebo controlled parallel-groups clinical trial designed to test the hypothesis that interventions (glycine or d-cycloserine) intended to increase glutamatergic activity by action at the NMDA receptor will reduce persistant negative symptoms and cognitive impairments of patients with schizophrenia or schizoaffective disorder. After an initial screening phase to establish clinical stability and eligibility, patients were assigned to one of three adjunctive treatments (placebo, d-cycloserine or glycine)for 16 weeks of double-blind treatment. Patients remained on a stable dose of antipsychotic therapy (other than clozapine) throughout the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '54 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diagnosis of schizophrenia or schizoaffective disorder\n* stable, enduring negative symptoms above a certain level (SANS \\>19)\n* clinically stable, with psychotic symptoms measured on BPRS below 19, anxiety/depression on BPRS below 15\n* extrapyramidal symptoms measured on SAS below 9\n* on stable antipsychotic regimen (not including clozapine)\n\nExclusion Criteria:\n\n* alcohol or substance dependence within last six months\n* alcohol or substance abuse within last month\n* organic brain disorder\n* medical condition whose pathology or treatment could alter the presentation or treatment of schizophrenia, including active tuberculosis or tuberculosis treatment, kidney stones, and uncontrolled diabetes mellitus\n* Female participants could not be pregnant and were required to be using a documented method of contraception.'}, 'identificationModule': {'nctId': 'NCT00222235', 'briefTitle': 'Adjunctive Treatment for Decreasing Symptoms of Schizophrenia', 'organization': {'class': 'OTHER', 'fullName': 'University of Maryland, Baltimore'}, 'officialTitle': 'Cognitive and Negative Symptoms in Schizophrenia Trial (CONSIST)', 'orgStudyIdInfo': {'id': 'R01MH059807', 'link': 'https://reporter.nih.gov/quickSearch/R01MH059807', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': 'R01MH059807', 'link': 'https://reporter.nih.gov/quickSearch/R01MH059807', 'type': 'NIH'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'd-cycloserine', 'type': 'DRUG'}, {'name': 'glycine', 'type': 'DRUG'}, {'name': 'placebo', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '90073', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'UCLA/VA Greater Los Angeles Health Care System', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '21228', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Maryland Psychiatric Research Center', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '11004', 'city': 'Glen Oaks', 'state': 'New York', 'country': 'United States', 'facility': 'Zucker Hillside Hospital', 'geoPoint': {'lat': 40.74705, 'lon': -73.71152}}, {'zip': '10982', 'city': 'Orangeburg', 'state': 'New York', 'country': 'United States', 'facility': 'Nathan S Kline Institute for Psychiatric Research', 'geoPoint': {'lat': 41.04649, 'lon': -73.94958}}, {'zip': '91531', 'city': 'Jerusalem', 'country': 'Israel', 'facility': 'Ezrath Nashim Association, Sarah Herzog Memorial Hospital', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}], 'overallOfficials': [{'name': 'William T Carpenter, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Maryland Psychiatric Research Center, Department of Psychiatry, University of Maryland School of Medicien'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Maryland, Baltimore', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}, {'name': 'The Zucker Hillside Hospital', 'class': 'OTHER'}, {'name': 'Nathan Kline Institute for Psychiatric Research', 'class': 'OTHER'}, {'name': 'University of California, Los Angeles', 'class': 'OTHER'}, {'name': 'Sarah Herzog Hospital', 'class': 'UNKNOWN'}, {'name': 'University of Maryland, College Park', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'P.I.', 'investigatorFullName': 'MPRC', 'investigatorAffiliation': 'University of Maryland, Baltimore'}}}}