Ignite Creation Date:
2025-12-24 @ 2:45 PM
Ignite Modification Date:
2026-01-04 @ 12:58 PM
Study NCT ID:
NCT03968159
Status:
COMPLETED
Last Update Posted:
2021-11-17
First Post:
2019-05-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Adjunctive Pimavanserin in Subjects With Major Depressive Disorder and Inadequate Response to Antidepressant Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2021-06-16', 'type': 'ACTUAL'}}}}, 'interventionBrowseModule': {'meshes': [{'id': 'C510793', 'term': 'pimavanserin'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'medicalinformation@acadia-pharm.com', 'phone': '858-261', 'title': 'Sr. Dir. Medical Information and Medical Communications', 'phoneExt': '2897', 'organization': 'Acadia Pharmaceuticals Inc.'}, 'certainAgreement': {'otherDetails': "Investigator may publish the study results, relative to their 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}, 'limitationsAndCaveats': {'description': 'In March 2020, recruitment of new patients was paused due to the emerging coronavirus disease 2019 (COVID-19) pandemic. At that point in time, about half of the planned patients had been randomized. The Sponsor decided to combine this trial with the identically designed trial ACP-103-054, with a prespecified combined statistical analysis plan. As a result, both trials were closed and proceeded with database lock and statistical analysis of the combined data. No further patients were enrolled.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse Events (AEs) were to be documented through 30 days after the last planned dose in the study which was to be administered at Week 6.', 'eventGroups': [{'id': 'EG000', 'title': 'Pimavanserin', 'description': 'Pimavanserin 34 mg administered orally as a single dose once daily', 'otherNumAtRisk': 148, 'deathsNumAtRisk': 148, 'otherNumAffected': 54, 'seriousNumAtRisk': 148, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Placebo tablets administered orally as a single dose once daily', 'otherNumAtRisk': 150, 'deathsNumAtRisk': 150, 'otherNumAffected': 43, 'seriousNumAtRisk': 150, 'deathsNumAffected': 0, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numEvents': 16, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numEvents': 49, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 39, 'numAffected': 27}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}], 'seriousEvents': [{'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Lower gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Multiple sclerosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Gastritis haemorrhagic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline to Week 5 in Hamilton Depression Scale (17 Items) (HAMD-17) Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pimavanserin', 'description': 'Pimavanserin 34 mg administered orally as a single dose once daily'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo tablets administered orally as a single dose once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '-9.0', 'spread': '0.58', 'groupId': 'OG000'}, {'value': '-8.1', 'spread': '0.58', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.2956', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSM difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.9', 'ciLowerLimit': '-2.5', 'ciUpperLimit': '0.8', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.82', 'statisticalMethod': 'Mixed-effects model for repeated measure', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 5', 'description': 'The HAMD-17 consists of 8 items with a score on a 3 point scale and 9 items with a score on a 5 point scale. The total score ranging from 0 to 52 will be calculated as the sum of the scores for all 17 items. Higher total scores denote more severe depression.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: all subjects who were randomized, received at least one dose of study drug, and had a baseline value and at least one postbaseline value for HAMD-17 total score.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 5 in Clinical Global Impression-Severity (CGI-S) Score for Depressive Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pimavanserin', 'description': 'Pimavanserin 34 mg administered orally as a single dose once daily'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo tablets administered orally as a single dose once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.4', 'spread': '0.10', 'groupId': 'OG000'}, {'value': '-1.1', 'spread': '0.10', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 5 weeks', 'description': "The CGI-S rates the severity of a subject's depression over the past 7 days and the score ranges from 1 to 7. Higher CGI-S scores denote more severe depression.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: all subjects who were randomized, received at least one dose of study drug, and had a baseline value and at least one postbaseline value for HAMD-17 total score.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 5 in Sheehan Disability Scale (SDS) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pimavanserin', 'description': 'Pimavanserin 34 mg administered orally as a single dose once daily'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo tablets administered orally as a single dose once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.5', 'spread': '0.22', 'groupId': 'OG000'}, {'value': '-2.1', 'spread': '0.22', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 5 weeks', 'description': 'The SDS is a 3-item subject-facing questionnaire used to evaluate impairments in the domains of work, social life/leisure, and family life/home responsibility. Subjects rate each item using an 11-point scale ranging from 0 (not at all) to 10 (extremely). Higher scores denote greater disability.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: all subjects who were randomized, received at least one dose of study drug, and had a baseline value and at least one postbaseline value for HAMD-17 total score.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 5 in the Changes in Sexual Functioning Questionnaire Short Form', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pimavanserin', 'description': 'Pimavanserin 34 mg administered orally as a single dose once daily'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo tablets administered orally as a single dose once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '3.4', 'spread': '0.66', 'groupId': 'OG000'}, {'value': '2.5', 'spread': '0.66', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 5 weeks', 'description': 'The CSFQ-14 is a 14-item version of the CSFQ. This is a patient-facing questionnaire, with a male version and a female version. The total score ranging from 14 to 70 will be calculated as the sum of the scores for all 14 items. Higher total scores denote better sexual functioning.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: all subjects who were randomized, received at least one dose of study drug, and had a baseline value and at least one postbaseline value for HAMD-17 total score.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 5 in Karolinska Sleepiness Scale (KSS) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pimavanserin', 'description': 'Pimavanserin 34 mg administered orally as a single dose once daily'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo tablets administered orally as a single dose once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.4', 'spread': '0.15', 'groupId': 'OG000'}, {'value': '-0.8', 'spread': '0.15', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 5 weeks', 'description': 'The KSS is a scale that measures the subject\'s drowsiness and is frequently used in studies measuring subjective sleepiness. Scoring is based on a 9-point verbally anchored scale going from "1 = extremely alert" to "9 = very sleepy, great effort to keep awake, fighting sleep". Higher scores denote more drowsiness.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: all subjects who were randomized, received at least one dose of study drug, and had a baseline value and at least one postbaseline value for HAMD-17 total score.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 1 in the HAMD-17 Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pimavanserin', 'description': 'Pimavanserin 34 mg administered orally as a single dose once daily'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo tablets administered orally as a single dose once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.8', 'spread': '0.34', 'groupId': 'OG000'}, {'value': '-3.2', 'spread': '0.34', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 1 week', 'description': 'The HAMD-17 consists of 8 items with a score on a 3 point scale and 9 items with a score on a 5 point scale. The total score ranging from 0 to 52 will be calculated as the sum of the scores for all 17 items. Higher total scores denote more severe depression.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: all subjects who were randomized, received at least one dose of study drug, and had a baseline value and at least one postbaseline value for HAMD-17 total score.'}, {'type': 'SECONDARY', 'title': 'Treatment Responder and Treatment Remission Rates at Week 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pimavanserin', 'description': 'Pimavanserin 34 mg administered orally as a single dose once daily'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo tablets administered orally as a single dose once daily'}], 'classes': [{'title': 'Responder', 'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}]}, {'title': 'Remitter', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, 5 weeks', 'description': 'The HAMD-17 consists of 8 items with a score on a 3 point scale and 9 items with a score on a 5 point scale. The total score ranging from 0 to 52 will be calculated as the sum of the scores for all 17 items. Treatment response is defined as a reduction from Baseline in HAMD-17 total score of 50% or more. Treatment remission is defined as a HAMD-17 total score ≤7.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: all subjects who were randomized, received at least one dose of study drug, and had a baseline value and at least one postbaseline value for HAMD-17 total score.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 5 in the Hamilton Depression (HAMD) Anxiety/Somatization Factor Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pimavanserin', 'description': 'Pimavanserin 34 mg administered orally as a single dose once daily'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo tablets administered orally as a single dose once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.5', 'spread': '0.21', 'groupId': 'OG000'}, {'value': '-2.5', 'spread': '0.21', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 5 weeks', 'description': 'The Anxiety/Somatization factor of the HAMD-17 includes 6 items: psychic anxiety, somatic anxiety, gastrointestinal somatic symptoms, general somatic symptoms, hypochondriasis, and insight. The HAMD-17 Anxiety/Somatization factor score ranging from 0 to 18 will be calculated as the sum of the scores for the 6 items. Higher scores denote more severe anxiety/somatization condition.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: all subjects who were randomized, received at least one dose of study drug, and had a baseline value and at least one postbaseline value for HAMD-17 total score.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 5 in the Barratt Impulsiveness Scale (BIS-11)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pimavanserin', 'description': 'Pimavanserin 34 mg administered orally as a single dose once daily'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo tablets administered orally as a single dose once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.0', 'spread': '0.64', 'groupId': 'OG000'}, {'value': '-2.5', 'spread': '0.64', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 5 weeks', 'description': 'The BIS-11 is a questionnaire designed to assess the personality/behavioral construct of impulsiveness. It is composed of 30 items describing common impulsive or non-impulsive (reverse scored items: 1, 7, 8, 9, 10, 12, 13, 15, 20, 29, and 30) behaviors and preferences. Items are scored on the following 4-point scale: Rarely/Never = 1; Occasionally = 2; Often = 3; Almost Always/Always = 4. For reverse scored items, a response of 1 is recoded to 4; 2 is recoded to 3; 3 is recoded to 2; and 4 is recoded to 1. The BIS-11 score ranging from 30 to 120 will be calculated as the sum of the scores for all 30 items. Higher scores denote more impulsiveness.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: all subjects who were randomized, received at least one dose of study drug, and had a baseline value and at least one postbaseline value for HAMD-17 total score.'}, {'type': 'SECONDARY', 'title': 'Clinical Global Impression-Improvement (CGI-I) Score for Depressive Symptoms at Week 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pimavanserin', 'description': 'Pimavanserin 34 mg administered orally as a single dose once daily'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo tablets administered orally as a single dose once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '2.7', 'spread': '0.09', 'groupId': 'OG000'}, {'value': '2.9', 'spread': '0.09', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 5 weeks', 'description': "The CGI-I rates the change in a subject's depression over the past 7 days relative to the subject's symptoms at Baseline and the score ranges from 1 to 7. Higher CGI-I scores denote less improvement in Depression.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: all subjects who were randomized, received at least one dose of study drug, and had a baseline value and at least one postbaseline value for HAMD-17 total score.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Pimavanserin', 'description': 'Pimavanserin 34 mg administered orally as a single dose once daily'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Placebo tablets administered orally as a single dose once daily'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '148'}, {'groupId': 'FG001', 'numSubjects': '150'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '135'}, {'groupId': 'FG001', 'numSubjects': '135'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '15'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Use of prohibited medication', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Not further specified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'The study was performed in patients with with major depressive disorder who had an inadequate response to antidepressant treatment.', 'preAssignmentDetails': 'During the screening period, patients were assessed for study eligibility, and prohibited medications were discontinued when medically appropriate.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'BG000'}, {'value': '150', 'groupId': 'BG001'}, {'value': '298', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Pimavanserin', 'description': 'Pimavanserin 34 mg administered orally as a single dose once daily'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Placebo tablets administered orally as a single dose once daily'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '47.2', 'spread': '13.45', 'groupId': 'BG000'}, {'value': '44.5', 'spread': '14.92', 'groupId': 'BG001'}, {'value': '45.8', 'spread': '14.25', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '96', 'groupId': 'BG000'}, {'value': '112', 'groupId': 'BG001'}, {'value': '208', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '52', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '90', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', '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': '6', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '137', 'groupId': 'BG000'}, {'value': '137', 'groupId': 'BG001'}, {'value': '274', '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': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '74', 'groupId': 'BG000'}, {'value': '74', 'groupId': 'BG001'}, {'value': '148', 'groupId': 'BG002'}]}]}, {'title': 'Finland', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}, {'title': 'Poland', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}, {'title': 'Russia', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}, {'title': 'Serbia', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}]}, {'title': 'Slovakia', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}, {'title': 'South Africa', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Ukraine', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}, {'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-06-21', 'size': 832095, 'label': 'Study Protocol: Study ACP-103-059 protocol (NCT03968159)', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-05-11T06:03', 'hasProtocol': True}, {'date': '2020-06-21', 'size': 832141, 'label': 'Study Protocol: Study ACP-103-054 protocol (NCT03999918)', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_002.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-09-21T01:34', 'hasProtocol': True}, {'date': '2020-06-22', 'size': 1881051, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-05-06T01:55', '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': 298}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-04-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2020-05-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-19', 'studyFirstSubmitDate': '2019-05-13', 'resultsFirstSubmitDate': '2021-05-21', 'studyFirstSubmitQcDate': '2019-05-29', 'lastUpdatePostDateStruct': {'date': '2021-11-17', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-10-19', 'studyFirstPostDateStruct': {'date': '2019-05-30', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-11-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline to Week 5 in Hamilton Depression Scale (17 Items) (HAMD-17) Total Score', 'timeFrame': 'Baseline, Week 5', 'description': 'The HAMD-17 consists of 8 items with a score on a 3 point scale and 9 items with a score on a 5 point scale. The total score ranging from 0 to 52 will be calculated as the sum of the scores for all 17 items. Higher total scores denote more severe depression.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline to Week 5 in Clinical Global Impression-Severity (CGI-S) Score for Depressive Symptoms', 'timeFrame': 'Baseline, 5 weeks', 'description': "The CGI-S rates the severity of a subject's depression over the past 7 days and the score ranges from 1 to 7. Higher CGI-S scores denote more severe depression."}, {'measure': 'Change From Baseline to Week 5 in Sheehan Disability Scale (SDS) Score', 'timeFrame': 'Baseline, 5 weeks', 'description': 'The SDS is a 3-item subject-facing questionnaire used to evaluate impairments in the domains of work, social life/leisure, and family life/home responsibility. Subjects rate each item using an 11-point scale ranging from 0 (not at all) to 10 (extremely). Higher scores denote greater disability.'}, {'measure': 'Change From Baseline to Week 5 in the Changes in Sexual Functioning Questionnaire Short Form', 'timeFrame': 'Baseline, 5 weeks', 'description': 'The CSFQ-14 is a 14-item version of the CSFQ. This is a patient-facing questionnaire, with a male version and a female version. The total score ranging from 14 to 70 will be calculated as the sum of the scores for all 14 items. Higher total scores denote better sexual functioning.'}, {'measure': 'Change From Baseline to Week 5 in Karolinska Sleepiness Scale (KSS) Score', 'timeFrame': 'Baseline, 5 weeks', 'description': 'The KSS is a scale that measures the subject\'s drowsiness and is frequently used in studies measuring subjective sleepiness. Scoring is based on a 9-point verbally anchored scale going from "1 = extremely alert" to "9 = very sleepy, great effort to keep awake, fighting sleep". Higher scores denote more drowsiness.'}, {'measure': 'Change From Baseline to Week 1 in the HAMD-17 Total Score', 'timeFrame': 'Baseline, 1 week', 'description': 'The HAMD-17 consists of 8 items with a score on a 3 point scale and 9 items with a score on a 5 point scale. The total score ranging from 0 to 52 will be calculated as the sum of the scores for all 17 items. Higher total scores denote more severe depression.'}, {'measure': 'Treatment Responder and Treatment Remission Rates at Week 5', 'timeFrame': 'Baseline, 5 weeks', 'description': 'The HAMD-17 consists of 8 items with a score on a 3 point scale and 9 items with a score on a 5 point scale. The total score ranging from 0 to 52 will be calculated as the sum of the scores for all 17 items. Treatment response is defined as a reduction from Baseline in HAMD-17 total score of 50% or more. Treatment remission is defined as a HAMD-17 total score ≤7.'}, {'measure': 'Change From Baseline to Week 5 in the Hamilton Depression (HAMD) Anxiety/Somatization Factor Score', 'timeFrame': 'Baseline, 5 weeks', 'description': 'The Anxiety/Somatization factor of the HAMD-17 includes 6 items: psychic anxiety, somatic anxiety, gastrointestinal somatic symptoms, general somatic symptoms, hypochondriasis, and insight. The HAMD-17 Anxiety/Somatization factor score ranging from 0 to 18 will be calculated as the sum of the scores for the 6 items. Higher scores denote more severe anxiety/somatization condition.'}, {'measure': 'Change From Baseline to Week 5 in the Barratt Impulsiveness Scale (BIS-11)', 'timeFrame': 'Baseline, 5 weeks', 'description': 'The BIS-11 is a questionnaire designed to assess the personality/behavioral construct of impulsiveness. It is composed of 30 items describing common impulsive or non-impulsive (reverse scored items: 1, 7, 8, 9, 10, 12, 13, 15, 20, 29, and 30) behaviors and preferences. Items are scored on the following 4-point scale: Rarely/Never = 1; Occasionally = 2; Often = 3; Almost Always/Always = 4. For reverse scored items, a response of 1 is recoded to 4; 2 is recoded to 3; 3 is recoded to 2; and 4 is recoded to 1. The BIS-11 score ranging from 30 to 120 will be calculated as the sum of the scores for all 30 items. Higher scores denote more impulsiveness.'}, {'measure': 'Clinical Global Impression-Improvement (CGI-I) Score for Depressive Symptoms at Week 5', 'timeFrame': 'Baseline, 5 weeks', 'description': "The CGI-I rates the change in a subject's depression over the past 7 days relative to the subject's symptoms at Baseline and the score ranges from 1 to 7. Higher CGI-I scores denote less improvement in Depression."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Adjunctive Treatment of Major Depressive Disorder']}, 'descriptionModule': {'briefSummary': 'To evaluate the efficacy and safety of adjunctive pimavanserin compared to placebo in subjects with major depressive disorder who have an inadequate response to antidepressant therapy', 'detailedDescription': 'Two separate studies, idential in design, were planned and initiated under 2 protocol IDs and NCTs, i.e. study ACP-103-54 (NCT03999918) and ACP-103-059 (NCT03968159). In March 2020, recruitment of new patients was paused due to the emerging coronavirus disease 2019 (COVID-19) pandemic. At that point in time, about half of the planned patients had been randomized. The Sponsor decided to combine the 2 identically designed trials, with a prespecified combined statistical analysis plan. As a result, both trials were closed and proceeded with database lock and statistical analysis of the combined data. No further patients were enrolled.\n\nThis entry now includes the combined data of studies ACP-103-054 and ACP-103-059.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Adult patients, aged 18 years and above\n2. A clinical diagnosis of major depressive disorder (MDD)\n3. Is being treated with one of the following SSRI or SNRI antidepressants:\n\n 1. Citalopram\n 2. Escitalopram\n 3. Paroxetine\n 4. Fluoxetine\n 5. Sertraline\n 6. Duloxetine\n 7. Venlafaxine\n 8. Desvenlafaxine\n 9. Venlafaxine XR\n4. Inadequate response to SSRI/SNRI antidepressant treatment is confirmed\n5. If the subject is female, she must not be pregnant or breastfeeding. She must also be of non-childbearing potential OR must agree to use acceptable methods of contraception\n\nExclusion Criteria:\n\n1. Has a history of psychotic disorder or is currently being treated or requires treatment for post-traumatic stress disorder, acute stress disorder, panic disorder, or obsessive compulsive disorder\n2. Has current evidence of delirium or an unstable neurological, cardiovascular, respiratory, gastrointestinal, renal, hepatic, hematologic, or other medical disorder, including cancer or malignancies that would affect the patient's ability to participate in the program\n3. Has a known history or symptoms of long QT syndrome\n4. Is determined to be inappropriate for the study for any reason\n\nAdditional inclusion/exclusion criteria apply. Patients 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': 'NCT03968159', 'briefTitle': 'Adjunctive Pimavanserin in Subjects With Major Depressive Disorder and Inadequate Response to Antidepressant Treatment', 'nctIdAliases': ['NCT03999918'], 'organization': {'class': 'INDUSTRY', 'fullName': 'ACADIA Pharmaceuticals Inc.'}, 'officialTitle': 'Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Adjunctive Pimavanserin in Subjects With Major Depressive Disorder and Inadequate Response to Antidepressant Treatment (ACP-103-054/059)', 'orgStudyIdInfo': {'id': 'ACP-103-054/059'}, 'secondaryIdInfos': [{'id': '2018-003251-37', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Drug - pimavanserin', 'description': 'Pimavanserin 34 mg tablets', 'interventionNames': ['Drug: Pimavanserin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo tablets', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Pimavanserin', 'type': 'DRUG', 'description': 'Pimavanserin 34 mg (provided as 2×17 mg tablets) administered orally as a single dose once daily', 'armGroupLabels': ['Drug - pimavanserin']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo (2×placebo tablets \\[size- and color-matched to pimavanserin\\]) administered orally as a single dose once daily', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham (UAB)', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '92845', 'city': 'Garden Grove', 'state': 'California', 'country': 'United States', 'facility': 'CNS Network', 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'state': 'Illinois', 'country': 'United States', 'facility': 'Capstone Clinical Research', 'geoPoint': {'lat': 42.28308, 'lon': -87.95313}}, {'zip': '66208', 'city': 'Prairie Village', 'state': 'Kansas', 'country': 'United States', 'facility': 'Collective Medical Research, LLC', 'geoPoint': {'lat': 38.99167, 'lon': -94.63357}}, {'zip': '71201', 'city': 'Monroe', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Clinical Trials of America (Monroe, LA)', 'geoPoint': {'lat': 32.50931, 'lon': -92.1193}}, {'zip': '02472', 'city': 'Watertown', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Adams Clinical', 'geoPoint': {'lat': 42.37093, 'lon': -71.18283}}, {'zip': '63304', 'city': 'Saint Charles', 'state': 'Missouri', 'country': 'United States', 'facility': 'St. Charles Psychiatric Associates-Midwest Research Group', 'geoPoint': {'lat': 38.78394, 'lon': -90.48123}}, {'zip': '11229', 'city': 'Brooklyn', 'state': 'New York', 'country': 'United States', 'facility': 'Integrative Clinical Trials', 'geoPoint': {'lat': 40.6501, 'lon': -73.94958}}, {'zip': '11235', 'city': 'Brooklyn', 'state': 'New York', 'country': 'United States', 'facility': 'Social Psychiatry Research Institute (SPRI)', 'geoPoint': {'lat': 40.6501, 'lon': -73.94958}}, {'zip': '10029', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Mount Sinai Hospital', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10128', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'The Medical Research Network, LLC', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '14618', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'Finger Lake Clinical Research', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '28601', 'city': 'Hickory', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Clinical Trial of America, LLC', 'geoPoint': {'lat': 35.73319, 'lon': 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Pleasant', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Coastal Carolina Research Center', 'geoPoint': {'lat': 32.79407, 'lon': -79.86259}}, {'zip': '37067', 'city': 'Franklin', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Psychiatric Consultants, PC', 'geoPoint': {'lat': 35.92506, 'lon': -86.86889}}, {'zip': '38119', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Clinical Neuroscience Solutions CNS Healthcare', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'zip': '38119', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Research Strategies of Memphis, LLC', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'zip': '75231', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Future Search Trials of Dallas', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Baylor College of Medicine', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Clinical Trials of Texas, Inc.', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '76309', 'city': 'Wichita Falls', 'state': 'Texas', 'country': 'United States', 'facility': 'Grayline Research Center', 'geoPoint': {'lat': 33.91371, 'lon': -98.49339}}, {'zip': '53188', 'city': 'Waukesha', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'IPC Research', 'geoPoint': {'lat': 43.01168, 'lon': -88.23148}}, {'zip': '00100', 'city': 'Helsinki', 'country': 'Finland', 'facility': 'ARTES Psykiatrinen Palvelukeskus Oy (Mederon Ltd.)', 'geoPoint': {'lat': 60.16952, 'lon': 24.93545}}, {'zip': '70110', 'city': 'Kuopio', 'country': 'Finland', 'facility': 'Savon Psykiatripalvelu Oy', 'geoPoint': {'lat': 62.89238, 'lon': 27.67703}}, {'zip': '90100', 'city': 'Oulu', 'country': 'Finland', 'facility': 'Oulu Mentalcare Oy', 'geoPoint': {'lat': 65.01236, 'lon': 25.46816}}, {'zip': '28130', 'city': 'Pori', 'country': 'Finland', 'facility': 'Satakunnan Psykiatripalvelu Oy at Mehiläinen Pori', 'geoPoint': {'lat': 61.48072, 'lon': 21.78518}}, {'zip': '33200', 'city': 'Tampere', 'country': 'Finland', 'facility': 'Psykiatri- ja psykologikeskus Mentoria', 'geoPoint': {'lat': 61.49911, 'lon': 23.78712}}, {'zip': '97-400', 'city': 'Bełchatów', 'country': 'Poland', 'facility': 'Gabinet Lekarski Psychiatryczny Ireneusz Kaczorowski', 'geoPoint': {'lat': 51.36883, 'lon': 19.35671}}, {'zip': '85-080', 'city': 'Bydgoszcz', 'country': 'Poland', 'facility': 'Przychodnia Śródmieście Sp. z o.o.', 'geoPoint': {'lat': 53.1235, 'lon': 18.00762}}, {'zip': '80-438', 'city': 'Gdansk', 'country': 'Poland', 'facility': 'Indywidualna Specijalistyczna Praktyka Lekarska Wiesław Jerzy Cubała', 'geoPoint': {'lat': 54.35227, 'lon': 18.64912}}, {'zip': '64-100', 'city': 'Leszno', 'country': 'Poland', 'facility': 'Nzop Mentis', 'geoPoint': {'lat': 51.84034, 'lon': 16.57494}}, {'zip': '62-064', 'city': 'Plewiska', 'country': 'Poland', 'facility': 'Neurologiczny NZOZ im. dr n. med. Hanki', 'geoPoint': {'lat': 52.36706, 'lon': 16.80985}}, {'zip': '70-480', 'city': 'Szczecin', 'country': 'Poland', 'facility': 'Zachodniopomorski Instytut Psychoterapii', 'geoPoint': {'lat': 53.42894, 'lon': 14.55302}}, {'zip': '115522', 'city': 'Moscow', 'country': 'Russia', 'facility': 'Mental Health Research Center, Department #6', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '190121', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'St. Nicholas the Wonder Worker Psychiatric Hospital', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '195176', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'Psychoneurological Dispensary # 5', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '199004', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'City Narcology Hospital', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '443016', 'city': 'Samara', 'country': 'Russia', 'facility': 'Samara Psychiatric Hospital', 'geoPoint': {'lat': 53.20767, 'lon': 50.13553}}, {'zip': '410028', 'city': 'Saratov', 'country': 'Russia', 'facility': 'Saratov City Clinical Hospital # 2 n.a. 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