Ignite Creation Date:
2025-12-24 @ 3:51 PM
Ignite Modification Date:
2026-02-26 @ 12:41 AM
Study NCT ID:
NCT02970292
Status:
COMPLETED
Last Update Posted:
2020-06-17
First Post:
2016-11-18
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy and Safety of Adjunctive Pimavanserin for the Treatment of Schizophrenia (ENHANCE-1)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Spain']}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C510793', 'term': 'pimavanserin'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'medicalinformation@acadia-pharm.com', 'phone': '+1-858-261-2897', 'title': 'Sr. Dir. Medical Information and Medical Communications', 'organization': 'ACADIA Pharmaceuticals Inc.'}, 'certainAgreement': {'otherDetails': "Investigator may publish the study results, relative to his/her own patients, only after review, comment and approval by the sponsor. No publication of confidential information shall be made without the sponsor's Prior written consent. At least 60 days prior to submitting a manuscript or prior to any public presentation, a copy of the manuscript or presentation will be provided to the sponsor for review and comment. The sponsor has 60 days to review and comment.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From baseline to Week 6', 'description': 'The analysis population were those patients who received at least one dose of the study drug. Patients were classified according to the actual treatment received.', 'eventGroups': [{'id': 'EG000', 'title': 'Pimavanserin', 'description': "Patients started treatment with pimavanserin 20 mg once daily (QD). At the Week 1, Week 2 and Week 3 visit, the dose could be increased to 34 mg QD or decreased to 10 mg QD at the investigator's discretion (to improve symptom reliev or tolerability, respectively). Thereafter, the daily dose was to remain the same for the remainder of the study.\n\nPatients were to continue their background antipsychotic treatment.", 'otherNumAtRisk': 198, 'deathsNumAtRisk': 198, 'otherNumAffected': 31, 'seriousNumAtRisk': 198, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Pimavanserin-matching Placebo.\n\nPatients were to continue their background antipsychotic treatment.', 'otherNumAtRisk': 198, 'deathsNumAtRisk': 198, 'otherNumAffected': 31, 'seriousNumAtRisk': 198, 'deathsNumAffected': 0, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numEvents': 16, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 198, 'numEvents': 24, 'numAffected': 18}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numEvents': 19, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 198, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 198, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}], 'seriousEvents': [{'term': 'Schizophrenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 198, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Hallucination auditory', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 198, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Psychotic symptom', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 198, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Self-injurious ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 198, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Suicidal ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 198, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline to Week 6 in the Positive and Negative Syndrome Scale (PANSS) Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '193', 'groupId': 'OG000'}, {'value': '196', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pimavanserin', 'description': "Patients started treatment with pimavanserin 20 mg once daily (QD). At the Week 1, Week 2 and Week 3 visit, the dose could be increased to 34 mg QD or decreased to 10 mg QD at the investigator's discretion (to improve symptom reliev or tolerability, respectively). Thereafter, the daily dose was to remain the same for the remainder of the study.\n\nPatients were to continue their background antipsychotic treatment."}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Pimavanserin-matching Placebo.\n\nPatients were to continue their background antipsychotic treatment.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '193', 'groupId': 'OG000'}, {'value': '196', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '88.3', 'spread': '0.68', 'groupId': 'OG000'}, {'value': '88.1', 'spread': '0.61', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline to Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'OG000'}, {'value': '189', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-15.3', 'spread': '0.93', 'groupId': 'OG000'}, {'value': '-13.4', 'spread': '0.83', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0940', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in MMRM LSMs', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.1', 'ciLowerLimit': '-4.5', 'ciUpperLimit': '0.4', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.24', 'statisticalMethod': 'mixed-effects model for repeated measure', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'From baseline to Week 6', 'description': 'The PANSS is a 30-item scale used to evaluate the presence, absence, and severity of schizophrenia symptoms. The 30 items are arranged as 7 positive symptom items (P1 to P7), 7 negative symptom items (N1 to N7), and 16 general psychopathology symptom items (G1 to G16). Items are scored over the past week (7 days) on a 7-point scale ranging from 1 (absent) to 7 (extreme). The PANSS total score can range from a minimum of 30 to a maximum of 210, where a higher score signifies greater severity of schizophrenia symptoms.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients randomised and treated (at least 1 dose of study medication) who had both a baseline value and at least 1 post-baseline value for the PANSS total score.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 6 in the Clinical Global Impression-Severity (CGI-S) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '193', 'groupId': 'OG000'}, {'value': '196', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pimavanserin', 'description': "Patients started treatment with pimavanserin 20 mg once daily (QD). At the Week 1, Week 2 and Week 3 visit, the dose could be increased to 34 mg QD or decreased to 10 mg QD at the investigator's discretion (to improve symptom reliev or tolerability, respectively). Thereafter, the daily dose was to remain the same for the remainder of the study.\n\nPatients were to continue their background antipsychotic treatment."}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Pimavanserin-matching Placebo.\n\nPatients were to continue their background antipsychotic treatment.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '193', 'groupId': 'OG000'}, {'value': '196', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.6', 'spread': '0.04', 'groupId': 'OG000'}, {'value': '4.6', 'spread': '0.04', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline to Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'OG000'}, {'value': '189', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.8', 'spread': '0.06', 'groupId': 'OG000'}, {'value': '-0.7', 'spread': '0.05', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From baseline to Week 6', 'description': 'The CGI-S is a 1-item scale, used to rate the severity of the disorder from 0 (not assessed) to 7 (among the most extremely ill patients). A higher CGI-S score denotes greater severity of the disorder.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients randomised and treated (at least 1 dose of study medication) who had both a baseline value and at least 1 post-baseline value for the PANSS total score.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline (CFBL) to Week 6 in PANSS Subscale Scores, i.e. PANSS Positive Subscale Score, PANSS Negative Subscale Score and PANSS General Psychopathological Scale Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '193', 'groupId': 'OG000'}, {'value': '196', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pimavanserin', 'description': "Patients started treatment with pimavanserin 20 mg once daily (QD). At the Week 1, Week 2 and Week 3 visit, the dose could be increased to 34 mg QD or decreased to 10 mg QD at the investigator's discretion (to improve symptom reliev or tolerability, respectively). Thereafter, the daily dose was to remain the same for the remainder of the study.\n\nPatients were to continue their background antipsychotic treatment."}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Pimavanserin-matching Placebo.\n\nPatients were to continue their background antipsychotic treatment.'}], 'classes': [{'title': 'PANSS positive scale BL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '193', 'groupId': 'OG000'}, {'value': '196', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '23.0', 'spread': '0.25', 'groupId': 'OG000'}, {'value': '22.8', 'spread': '0.23', 'groupId': 'OG001'}]}]}, {'title': 'PANSS positive scale CFBL to 6 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'OG000'}, {'value': '189', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-5.4', 'spread': '0.34', 'groupId': 'OG000'}, {'value': '-4.9', 'spread': '0.30', 'groupId': 'OG001'}]}]}, {'title': 'PANSS negative scale BL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '193', 'groupId': 'OG000'}, {'value': '196', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '23.0', 'spread': '0.29', 'groupId': 'OG000'}, {'value': '23.1', 'spread': '0.29', 'groupId': 'OG001'}]}]}, {'title': 'PANSS negative scale CFBL to 6 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'OG000'}, {'value': '189', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.8', 'spread': '0.28', 'groupId': 'OG000'}, {'value': '-2.1', 'spread': '0.28', 'groupId': 'OG001'}]}]}, {'title': 'PANSS general psychopatholigy scale BL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '193', 'groupId': 'OG000'}, {'value': '196', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '42.4', 'spread': '0.45', 'groupId': 'OG000'}, {'value': '42.2', 'spread': '0.45', 'groupId': 'OG001'}]}]}, {'title': 'PANSS gen. psychopath. scale CFBL to 6 w', 'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'OG000'}, {'value': '189', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-7.2', 'spread': '0.47', 'groupId': 'OG000'}, {'value': '-6.4', 'spread': '0.47', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From baseline to Week 6', 'description': 'The PANSS is a 30-item scale used to evaluate the presence, absence, and severity of schizophrenia symptoms. The 30 items are arranged as 7 positive symptom items (P1 to P7), 7 negative symptom items (N1 to N7), and 16 general psychopathology symptom items (G1 to G16). Items are scored over the past week (7 days) on a 7-point scale ranging from 1 (absent) to 7 (extreme).\n\nThe PANSS positive subscale score can range from 7 to 49; the PANSS negative subscale score can range from 7 to 49; the PANSS general psychopathology scale score can range from 16 to 112.\n\nFor each of the subscale scores, a higher score signifies greater severity of schizophrenia symptoms.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients randomised and treated (at least 1 dose of study medication) who had both a baseline value and at least 1 post-baseline value for the PANSS total score.'}, {'type': 'SECONDARY', 'title': 'PANSS Responders', 'denoms': [{'units': 'Participants', 'counts': [{'value': '193', 'groupId': 'OG000'}, {'value': '196', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pimavanserin', 'description': "Patients started treatment with pimavanserin 20 mg once daily (QD). At the Week 1, Week 2 and Week 3 visit, the dose could be increased to 34 mg QD or decreased to 10 mg QD at the investigator's discretion (to improve symptom reliev or tolerability, respectively). Thereafter, the daily dose was to remain the same for the remainder of the study.\n\nPatients were to continue their background antipsychotic treatment."}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Pimavanserin-matching Placebo.\n\nPatients were to continue their background antipsychotic treatment.'}], 'classes': [{'title': 'PANSS total score reduction >=20%', 'categories': [{'measurements': [{'value': '109', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}]}, {'title': 'PANSS total score reduction >=30%', 'categories': [{'measurements': [{'value': '71', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From baseline to Week 6', 'description': 'Porportion of patients showing a PANSS response of \\>=20% or \\>=30% reduction in PANSS total score PANSS total score reduction signifies improvement.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients randomised and treated (at least 1 dose of study medication) who had both a baseline value and at least 1 post-baseline value for the PANSS total score.'}, {'type': 'SECONDARY', 'title': 'Clinical Global Impression-Improvement (CGI-I) Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '193', 'groupId': 'OG000'}, {'value': '196', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pimavanserin', 'description': "Patients started treatment with pimavanserin 20 mg once daily (QD). At the Week 1, Week 2 and Week 3 visit, the dose could be increased to 34 mg QD or decreased to 10 mg QD at the investigator's discretion (to improve symptom reliev or tolerability, respectively). Thereafter, the daily dose was to remain the same for the remainder of the study.\n\nPatients were to continue their background antipsychotic treatment."}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Pimavanserin-matching Placebo.\n\nPatients were to continue their background antipsychotic treatment.'}], 'classes': [{'title': 'CGI-I response (MN)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '193', 'groupId': 'OG000'}, {'value': '196', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '68', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}]}, {'title': 'CGI-I response (OC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'OG000'}, {'value': '189', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '68', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From baseline to Week 6', 'description': 'The CGI-I is a 1-item scale, used to rate the improvement from 1 (very much improved) to 7 (very much worse). Higher scores denote less improvement.\n\nA CGI-I score of 1 or 2 was counted as response. The Analysis was performed twice; once including missing values as non-responders (MN) and once including only observed cases (OC).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients randomised and treated (at least 1 dose of study medication) who had both a baseline value and at least 1 post-baseline value for the PANSS total score.'}, {'type': 'SECONDARY', 'title': 'Clinical Global Impression-Improvement (CGI-I) Score at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'OG000'}, {'value': '189', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pimavanserin', 'description': "Patients started treatment with pimavanserin 20 mg once daily (QD). At the Week 1, Week 2 and Week 3 visit, the dose could be increased to 34 mg QD or decreased to 10 mg QD at the investigator's discretion (to improve symptom reliev or tolerability, respectively). Thereafter, the daily dose was to remain the same for the remainder of the study.\n\nPatients were to continue their background antipsychotic treatment."}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Pimavanserin-matching Placebo.\n\nPatients were to continue their background antipsychotic treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.8', 'spread': '0.07', 'groupId': 'OG000'}, {'value': '3.0', 'spread': '0.07', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From baseline to Week 6', 'description': 'The CGI-I is a 1-item scale, used to rate the improvement from 1 (very much improved) to 7 (very much worse). Higher scores denote less improvement.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients randomised and treated (at least 1 dose of study medication) who had both a baseline value and at least 1 post-baseline value for the PANSS total score.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 6 in Personal and Social Performance (PSP) Scale Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '193', 'groupId': 'OG000'}, {'value': '196', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pimavanserin', 'description': "Patients started treatment with pimavanserin 20 mg once daily (QD). At the Week 1, Week 2 and Week 3 visit, the dose could be increased to 34 mg QD or decreased to 10 mg QD at the investigator's discretion (to improve symptom reliev or tolerability, respectively). Thereafter, the daily dose was to remain the same for the remainder of the study.\n\nPatients were to continue their background antipsychotic treatment."}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Pimavanserin-matching Placebo.\n\nPatients were to continue their background antipsychotic treatment.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '193', 'groupId': 'OG000'}, {'value': '196', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '51.8', 'spread': '0.79', 'groupId': 'OG000'}, {'value': '51.6', 'spread': '0.78', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline to Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'OG000'}, {'value': '188', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.8', 'spread': '0.71', 'groupId': 'OG000'}, {'value': '5.7', 'spread': '0.64', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From baseline to Week 6', 'description': 'The PSP is a validated 100-point (1 to100) single-item rating scale to assess the psychosocial functioning of patients with schizophrenia. The maximum score is 100. Higher scores denote better psychosocial functioning.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients randomised and treated (at least 1 dose of study medication) who had both a baseline value and at least 1 post-baseline value for the PANSS total score.'}, {'type': 'SECONDARY', 'title': 'Drug Attitude Inventory (DAI-10)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '193', 'groupId': 'OG000'}, {'value': '196', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pimavanserin', 'description': "Patients started treatment with pimavanserin 20 mg once daily (QD). At the Week 1, Week 2 and Week 3 visit, the dose could be increased to 34 mg QD or decreased to 10 mg QD at the investigator's discretion (to improve symptom reliev or tolerability, respectively). Thereafter, the daily dose was to remain the same for the remainder of the study.\n\nPatients were to continue their background antipsychotic treatment."}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Pimavanserin-matching Placebo.\n\nPatients were to continue their background antipsychotic treatment.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '193', 'groupId': 'OG000'}, {'value': '196', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.6', 'spread': '0.24', 'groupId': 'OG000'}, {'value': '5.8', 'spread': '0.23', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline to Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'OG000'}, {'value': '188', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.4', 'spread': '0.20', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '0.20', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From baseline to Week 6', 'description': 'The DAI-10 contains 6 items (1, 3, 4, 7, 9, and 10) that a patient who is fully adherent to study medication would answer as "True" and 4 items (2, 5, 6, and 8) that a patient who is fully adherent to study medication would answer as "False." A correct answer is scored +1 and an incorrect answer is scored -1; the total score is derived as overall sum. The score can range from -10 to 10. Positive total scores indicate adherence and negative total scores indicate non-adherence. Higher scores denote better adherence.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients randomised and treated (at least 1 dose of study medication) who had both a baseline value and at least 1 post-baseline value for the PANSS total score.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 6 in Karolinska Sleepiness Scale (KSS) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '193', 'groupId': 'OG000'}, {'value': '196', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pimavanserin', 'description': "Patients started treatment with pimavanserin 20 mg once daily (QD). At the Week 1, Week 2 and Week 3 visit, the dose could be increased to 34 mg QD or decreased to 10 mg QD at the investigator's discretion (to improve symptom reliev or tolerability, respectively). Thereafter, the daily dose was to remain the same for the remainder of the study.\n\nPatients were to continue their background antipsychotic treatment."}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Pimavanserin-matching Placebo.\n\nPatients were to continue their background antipsychotic treatment.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '193', 'groupId': 'OG000'}, {'value': '196', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.6', 'spread': '0.11', 'groupId': 'OG000'}, {'value': '4.7', 'spread': '0.12', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline to Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'OG000'}, {'value': '189', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.5', 'spread': '0.12', 'groupId': 'OG000'}, {'value': '-0.2', 'spread': '0.12', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From baseline to Week 6', 'description': "The KSS is a self-reported measure of a patient's level of drowsiness. In this study, drowsiness was to be rated during the last week (7 days). Scoring is based on a 9-point verbally anchored scale ranging from 1 (extremely alert) to 9 (very sleepy, great effort to keep awake, fighting sleep). The maximum score is 9. Higher scores denote more drowsiness.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients randomised and treated (at least 1 dose of study medication) who had both a baseline value and at least 1 post-baseline value for the PANSS total score.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Pimavanserin', 'description': "Patients started treatment with pimavanserin 20 mg once daily (QD). At the Week 1, Week 2 and Week 3 visit, the dose could be increased to 34 mg QD or decreased to 10 mg QD at the investigator's discretion (to improve symptom reliev or tolerability, respectively). Thereafter, the daily dose was to remain the same for the remainder of the study.\n\nPatients were to continue their background antipsychotic treatment."}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Pimavanserin-matching Placebo.\n\nPatients were to continue their background antipsychotic treatment.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '198'}, {'groupId': 'FG001', 'numSubjects': '198'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '174'}, {'groupId': 'FG001', 'numSubjects': '190'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '8'}]}], 'dropWithdraws': [{'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Noncompliance with study drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '198', 'groupId': 'BG000'}, {'value': '198', 'groupId': 'BG001'}, {'value': '396', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Pimavanserin', 'description': "Patients started treatment with pimavanserin 20 mg once daily (QD). At the Week 1, Week 2 and Week 3 visit, the dose could be increased to 34 mg QD or decreased to 10 mg QD at the investigator's discretion (to improve symptom reliev or tolerability, respectively). Thereafter, the daily dose was to remain the same for the remainder of the study.\n\nPatients were to continue their background antipsychotic treatment."}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Pimavanserin-matching Placebo.\n\nPatients were to continue their background antipsychotic treatment.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '36.8', 'spread': '9.42', 'groupId': 'BG000'}, {'value': '37.4', 'spread': '9.45', 'groupId': 'BG001'}, {'value': '37.1', 'spread': '9.43', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '72', 'groupId': 'BG000'}, {'value': '78', 'groupId': 'BG001'}, {'value': '150', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '126', 'groupId': 'BG000'}, {'value': '120', 'groupId': 'BG001'}, {'value': '246', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '176', 'groupId': 'BG000'}, {'value': '172', 'groupId': 'BG001'}, {'value': '348', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Hungary', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '71', 'groupId': 'BG002'}]}]}, {'title': 'Czechia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Ukraine', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}]}, {'title': 'Poland', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}, {'title': 'Bulgaria', 'categories': [{'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '93', 'groupId': 'BG002'}]}]}, {'title': 'Lithuania', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}, {'title': 'Serbia', 'categories': [{'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '77', 'groupId': 'BG002'}]}]}, {'title': 'Russia', 'categories': [{'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '90', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'BMI', 'classes': [{'categories': [{'measurements': [{'value': '26.74', 'spread': '4.177', 'groupId': 'BG000'}, {'value': '26.92', 'spread': '4.029', 'groupId': 'BG001'}, {'value': '26.83', 'spread': '4.099', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m2', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'All patients randomised and treated with at least 1 dose of study drug'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-03-30', 'size': 1651713, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-05-28T01:32', 'hasProtocol': True}, {'date': '2018-06-01', 'size': 824586, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-05-28T01:32', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 396}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-10-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2019-06-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-05-29', 'studyFirstSubmitDate': '2016-11-18', 'resultsFirstSubmitDate': '2020-05-29', 'studyFirstSubmitQcDate': '2016-11-18', 'lastUpdatePostDateStruct': {'date': '2020-06-17', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-05-29', 'studyFirstPostDateStruct': {'date': '2016-11-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-06-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-05-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline to Week 6 in the Positive and Negative Syndrome Scale (PANSS) Total Score', 'timeFrame': 'From baseline to Week 6', 'description': 'The PANSS is a 30-item scale used to evaluate the presence, absence, and severity of schizophrenia symptoms. The 30 items are arranged as 7 positive symptom items (P1 to P7), 7 negative symptom items (N1 to N7), and 16 general psychopathology symptom items (G1 to G16). Items are scored over the past week (7 days) on a 7-point scale ranging from 1 (absent) to 7 (extreme). The PANSS total score can range from a minimum of 30 to a maximum of 210, where a higher score signifies greater severity of schizophrenia symptoms.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline to Week 6 in the Clinical Global Impression-Severity (CGI-S) Score', 'timeFrame': 'From baseline to Week 6', 'description': 'The CGI-S is a 1-item scale, used to rate the severity of the disorder from 0 (not assessed) to 7 (among the most extremely ill patients). A higher CGI-S score denotes greater severity of the disorder.'}, {'measure': 'Change From Baseline (CFBL) to Week 6 in PANSS Subscale Scores, i.e. PANSS Positive Subscale Score, PANSS Negative Subscale Score and PANSS General Psychopathological Scale Score', 'timeFrame': 'From baseline to Week 6', 'description': 'The PANSS is a 30-item scale used to evaluate the presence, absence, and severity of schizophrenia symptoms. The 30 items are arranged as 7 positive symptom items (P1 to P7), 7 negative symptom items (N1 to N7), and 16 general psychopathology symptom items (G1 to G16). Items are scored over the past week (7 days) on a 7-point scale ranging from 1 (absent) to 7 (extreme).\n\nThe PANSS positive subscale score can range from 7 to 49; the PANSS negative subscale score can range from 7 to 49; the PANSS general psychopathology scale score can range from 16 to 112.\n\nFor each of the subscale scores, a higher score signifies greater severity of schizophrenia symptoms.'}, {'measure': 'PANSS Responders', 'timeFrame': 'From baseline to Week 6', 'description': 'Porportion of patients showing a PANSS response of \\>=20% or \\>=30% reduction in PANSS total score PANSS total score reduction signifies improvement.'}, {'measure': 'Clinical Global Impression-Improvement (CGI-I) Response', 'timeFrame': 'From baseline to Week 6', 'description': 'The CGI-I is a 1-item scale, used to rate the improvement from 1 (very much improved) to 7 (very much worse). Higher scores denote less improvement.\n\nA CGI-I score of 1 or 2 was counted as response. The Analysis was performed twice; once including missing values as non-responders (MN) and once including only observed cases (OC).'}, {'measure': 'Clinical Global Impression-Improvement (CGI-I) Score at Week 6', 'timeFrame': 'From baseline to Week 6', 'description': 'The CGI-I is a 1-item scale, used to rate the improvement from 1 (very much improved) to 7 (very much worse). Higher scores denote less improvement.'}, {'measure': 'Change From Baseline to Week 6 in Personal and Social Performance (PSP) Scale Score', 'timeFrame': 'From baseline to Week 6', 'description': 'The PSP is a validated 100-point (1 to100) single-item rating scale to assess the psychosocial functioning of patients with schizophrenia. The maximum score is 100. Higher scores denote better psychosocial functioning.'}, {'measure': 'Drug Attitude Inventory (DAI-10)', 'timeFrame': 'From baseline to Week 6', 'description': 'The DAI-10 contains 6 items (1, 3, 4, 7, 9, and 10) that a patient who is fully adherent to study medication would answer as "True" and 4 items (2, 5, 6, and 8) that a patient who is fully adherent to study medication would answer as "False." A correct answer is scored +1 and an incorrect answer is scored -1; the total score is derived as overall sum. The score can range from -10 to 10. Positive total scores indicate adherence and negative total scores indicate non-adherence. Higher scores denote better adherence.'}, {'measure': 'Change From Baseline to Week 6 in Karolinska Sleepiness Scale (KSS) Score', 'timeFrame': 'From baseline to Week 6', 'description': "The KSS is a self-reported measure of a patient's level of drowsiness. In this study, drowsiness was to be rated during the last week (7 days). Scoring is based on a 9-point verbally anchored scale ranging from 1 (extremely alert) to 9 (very sleepy, great effort to keep awake, fighting sleep). The maximum score is 9. Higher scores denote more drowsiness."}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Schizophrenia']}, 'referencesModule': {'references': [{'pmid': '38264323', 'type': 'DERIVED', 'citation': 'Bugarski-Kirola D, Abbs B, Odetalla R, Liu IY, Darwish M, DeKarske D. Adherence to Background Antipsychotic and Pimavanserin in Patients with Schizophrenia: Post Hoc Analyses from the ENHANCE and ADVANCE Studies. Patient Prefer Adherence. 2024 Jan 19;18:207-216. doi: 10.2147/PPA.S436041. eCollection 2024.'}]}, 'descriptionModule': {'briefSummary': 'To evaluate the efficacy and safety of adjunctive pimavanserin compared with adjunctive placebo in the treatment of schizophrenia'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Adults patients, between 18 and 55 years of age\n2. A clinical diagnosis of schizophrenia with a minimum duration of 1 year\n3. The main background antipsychotic with which the subject is being treated must be one of the antipsychotics listed below:\n\n * Aripiprazole\n * Aripiprazole long-acting injectables:\n\n * Abilify Maintena®\n * Aristada®\n * Risperidone\n * Risperidone long-acting injection\n * Olanzapine\n * Lurasidone\n * Cariprazine\n * Brexpiprazole\n * Asenapine\n4. Has had a partial but inadequate response to antipsychotic treatment\n5. Has a history of response to antipsychotic treatment other than clozapine\n\nExclusion Criteria:\n\n1. Patient has a psychiatric disorder other than schizophrenia\n2. Patient has a history of resistance to antipsychotic treatment\n3. A urine drug screen (UDS) result at Baseline that indicates the presence of any tested prohibited substance of potential abuse, except marijuana\n\n a. Patients with a result indicating the presence of marijuana are permitted if they agree to abstain from marijuana use during the study and the medical monitor approves the subject's participation\n4. Patient has current evidence of a serious and/or unstable psychiatric, neurologic, cardiovascular, respiratory, gastrointestinal, renal, hepatic, hematologic, or other medical disorder, including cancer or malignancies, which would affect the patient's ability to participate in the program\n5. Patient has had a myocardial infarction in the last six months\n6. Patient is taking a medication or drug that prolongs the QT interval or has a family or personal history or symptoms of long QT syndrome\n\nPatients will be evaluated at screening to ensure that all criteria for study participation are met. Patients may be excluded from the study based on these assessments (and specifically if it is determined that their baseline health and psychiatric condition do not meet all pre-specified entry criteria)."}, 'identificationModule': {'nctId': 'NCT02970292', 'briefTitle': 'Efficacy and Safety of Adjunctive Pimavanserin for the Treatment of Schizophrenia (ENHANCE-1)', 'organization': {'class': 'INDUSTRY', 'fullName': 'ACADIA Pharmaceuticals Inc.'}, 'officialTitle': 'A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Adjunctive Pimavanserin for the Treatment of Schizophrenia', 'orgStudyIdInfo': {'id': 'ACP-103-034'}, 'secondaryIdInfos': [{'id': '2016-003434-24', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pimavanserin', 'description': 'Drug- pimavanserin 34 mg, 20 mg, or 10 mg taken as two tablets + background antipsychotic, once daily by mouth', 'interventionNames': ['Drug: Pimavanserin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo + background antipsychotic, taken as two tablets, once daily by mouth', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Pimavanserin', 'type': 'DRUG', 'description': 'Pimavanserin 34 mg, 20 mg, or 10 mg , taken as two tablets once daily by mouth', 'armGroupLabels': ['Pimavanserin']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo, taken as two tablets, once daily by mouth', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85012', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '72211', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '72758', 'city': 'Rogers', 'state': 'Arkansas', 'country': 'United States', 'geoPoint': {'lat': 36.33202, 'lon': -94.11854}}, {'zip': 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