Ignite Creation Date:
2025-12-24 @ 3:42 PM
Ignite Modification Date:
2026-02-02 @ 4:04 AM
Study NCT ID:
NCT04188392
Status:
COMPLETED
Last Update Posted:
2022-08-31
First Post:
2019-12-04
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Pimavanserin for Insomnia In Veterans With Posttraumatic Stress Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2022-08-11', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D013313', 'term': 'Stress Disorders, Post-Traumatic'}, {'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}], 'ancestors': [{'id': 'D040921', 'term': 'Stress Disorders, Traumatic'}, {'id': 'D000068099', 'term': 'Trauma and Stressor Related Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C510793', 'term': 'pimavanserin'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'melissa.jones2@bcm.edu', 'phone': '713-791-1414', 'title': 'Melissa B Jones, MD', 'phoneExt': '24747', 'organization': 'Baylor College of Medicine'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '10 weeks', 'description': 'Assessed with staff-administered questionnaire at all in-person and telephone visits following enrollment', 'eventGroups': [{'id': 'EG000', 'title': 'Open-label Treatment', 'description': 'pimavanserin 34mg at bedtime for 6 weeks\n\nPimavanserin: pimavanserin tablet', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'skin irritation', 'notes': 'From actigraphy watch', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'skin irritation', 'notes': 'From sleep study tubing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'sleepiness', 'notes': 'Mild sleepiness that resolved after first dose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'headache', 'notes': 'Similar in frequency and intensity to historical headaches and deemed by investigators to be unrelated to medication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'arthralgia', 'notes': 'Deemed by investigators to be unrelated to medication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'diarrhea', 'notes': 'Associated with brief gastrointestinal illness deemed by investigators to be unrelated to medication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'weight gain', 'notes': 'Deemed by investigators to be unrelated to medication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Recruitment Rates', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Open-label Treatment', 'description': 'pimavanserin 34mg at bedtime for 6 weeks\n\nPimavanserin: pimavanserin tablet'}], 'classes': [{'categories': [{'measurements': [{'value': '1.03', 'groupId': 'OG000', 'lowerLimit': '0.38', 'upperLimit': '2.25'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Rate (per month)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.03', 'ciLowerLimit': '0.38', 'ciUpperLimit': '2.25', 'estimateComment': 'Based on 6 subjects enrolled over 5.8 months of recruitment', 'groupDescription': 'Recruitment goal of 6 subjects total.', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Rate of subjects enrolled per month of recruitment; based on 6 subjects enrolled over 5.8 months of recruitment.'}], 'paramType': 'MEAN', 'timeFrame': 'Total duration of recruitment time (5.8 months)', 'description': 'The rate of enrollment per month; goal of 6 subjects total', 'unitOfMeasure': 'participants enrolled per month', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects enrolled into open label treatment'}, {'type': 'PRIMARY', 'title': 'Retention Rates', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Open-label Treatment', 'description': 'pimavanserin 34mg at bedtime for 6 weeks\n\nPimavanserin: pimavanserin tablet'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Point estimate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1', 'ciLowerLimit': '0.54', 'ciUpperLimit': '1', 'estimateComment': 'Point estimate = 100% (95% C.I. 54%,100%)', 'groupDescription': 'Binary outcome (completed protocol yes vs. no); goal of 75% of subjects completing protocol', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Total participants = 6; completed protocol: yes = 6, no = 0', 'otherAnalysisDescription': 'Point estimate of completion rate and 95% confidence interval'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '10 weeks (overall study)', 'description': 'The number of subjects who complete the protocol in its entirety; goal of 75% of subjects enrolled into treatment', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects enrolled into open-label treatment'}, {'type': 'SECONDARY', 'title': 'Mean Change in Duration of Stage N3 Sleep Pre- and Post-treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Open-label Treatment', 'description': 'pimavanserin 34mg at bedtime for 6 weeks\n\nPimavanserin: pimavanserin tablet'}], 'classes': [{'categories': [{'measurements': [{'value': '21.7', 'spread': '39.57', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.2873', 'groupIds': ['OG000'], 'paramType': 'Mean of the differences', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '21.7', 'ciLowerLimit': '-27.4', 'ciUpperLimit': '70.8', 'pValueComment': 'A priori significance threshold of p\\<0.05', 'groupDescription': 'alternative hypothesis: true difference in means is not equal to 0', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER', 'statisticalComment': 't=1.2263, df=4', 'nonInferiorityComment': 'paired t-test'}], 'paramType': 'MEAN', 'timeFrame': '6 weeks (time between baseline and closeout polysomnogram)', 'description': 'The mean difference in duration of stage N3 sleep from baseline polysomnogram to week-6 polysomnogram (\\[Time in N3 post-treatment\\] - \\[Time in N3 at baseline polysomnogram\\])', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects enrolled in open-label treatment and completed baseline and post-treatment polysomnogram (1 subject could not complete post-treatment polysomnogram due to pandemic).'}, {'type': 'SECONDARY', 'title': 'Discontinuation Rates Due to Adverse Effects', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Open-label Treatment', 'description': 'pimavanserin 34mg at bedtime for 6 weeks\n\nPimavanserin: pimavanserin tablet'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Point estimate, 95% confidence interval', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0', 'ciLowerLimit': '0', 'ciUpperLimit': '0.46', 'estimateComment': 'Discontinuation rates due to adverse effects: Point estimate 0% (95% C.I. 0%, 45.9%)', 'groupDescription': 'Binary outcome: Discontinued due to adverse effects yes vs. no', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Total participants = 6; discontinued due to adverse effects: yes = 0, no =6'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '10 weeks (overall study duration)', 'description': 'The number of subjects who discontinue the protocol due to adverse effects (from either protocol or medication)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of subjects enrolled into open-label treatment'}, {'type': 'SECONDARY', 'title': 'Completion Rates of Key Outcome Measures', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Open-label Treatment', 'description': 'pimavanserin 34mg at bedtime for 6 weeks\n\nPimavanserin: pimavanserin tablet'}], 'classes': [{'title': 'Completed sleep study 1', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Completed sleep study 2', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Completed sleep study 3', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'At least 4 days of actigraphy pre-treatment', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'At least 4 days of actigraphy post-treatment', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'At least 4 days of sleep diary pre-treatment', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'At least 4 days of sleep diary post-treatment', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'point estimate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1', 'ciLowerLimit': '0.54', 'ciUpperLimit': '1', 'estimateComment': 'Point estimate of completion rate for sleep study 1 = 100% (95% C.I. 54%, 100%)', 'groupDescription': 'Binary outcome: Completed sleep study 1 yes vs. no', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Total participants = 6; completed sleep study 1: yes = 6, no=0'}, {'groupIds': ['OG000'], 'paramType': 'point estimate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1', 'ciLowerLimit': '0.54', 'ciUpperLimit': '1', 'estimateComment': 'Point estimate of completion rate for sleep study 2 = 100% (95% C.I. 54%, 100%)', 'groupDescription': 'Binary outcome: completed sleep study 2 yes vs. no', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Total participants = 6; completed sleep study 2: yes = 6, no=0'}, {'groupIds': ['OG000'], 'paramType': 'point estimate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.83', 'ciLowerLimit': '0.36', 'ciUpperLimit': '0.996', 'estimateComment': 'Point estimate of completion rate for sleep study 3 = 83.3% (95% C.I. 36%, 99.6%)', 'groupDescription': 'Binary outcome: completed sleep study 3 yes vs. no', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Total participants = 6; completed sleep study 3: yes = 5, no=1'}, {'groupIds': ['OG000'], 'paramType': 'point estimate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1', 'ciLowerLimit': '0.54', 'ciUpperLimit': '1', 'estimateComment': 'Point estimate of completion rate for at least 4 days of actigraphy pre-treatment = 100% (95% C.I. 54%, 100%).', 'groupDescription': 'Binary outcome: at least 4 days of actigraphy data pre-treatment yes vs. no', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Total participants = 6; at least 4 days of actigraphy data: yes = 6, no=0'}, {'groupIds': ['OG000'], 'paramType': 'point estimate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1', 'ciLowerLimit': '0.54', 'ciUpperLimit': '1', 'estimateComment': 'Point estimate of at least 4 days of actigraphy post-treatment = 100% (95% C.I. 54%, 100%)', 'groupDescription': 'Binary outcome: at least 4 days of actigraphy post-treatment yes vs. no', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Total participants = 6; at least 4 days of actigraphy post-treatment: yes = 6, no =0'}, {'groupIds': ['OG000'], 'paramType': 'point estimate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1', 'ciLowerLimit': '0.54', 'ciUpperLimit': '1', 'estimateComment': 'Point estimate of at least 4 days of sleep diary pre-treatment = 100% (95% C.I. 54%, 100%)', 'groupDescription': 'Binary outcome: at least 4 days of sleep diary pre-treatment yes vs. no', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Total participants = 6; at least 4 days of sleep diary pre-treatment: yes = 6, no = 0'}, {'groupIds': ['OG000'], 'paramType': 'point estimate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1', 'ciLowerLimit': '0.54', 'ciUpperLimit': '1', 'estimateComment': 'Point estimate of at least 4 days of sleep diary post-treatment = 100% (95% C.I. 54%, 100%)', 'groupDescription': 'Binary outcome: at least 4 days of sleep diary post-treatment yes vs. no', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Total participants = 6; at least 4 days of sleep diary post-treatment: yes = 6, no = 0'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '10 weeks (overall study duration)', 'description': 'The percentage of participants who complete subject and objective measures of insomnia, including sleep diaries, actigraphy, and attended polysomnography', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects enrolled into open-label treatment'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Open-label Treatment', 'description': 'pimavanserin 34mg at bedtime for 6 weeks\n\nPimavanserin: pimavanserin tablet'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}]}, {'type': 'Sleep Studies 1 and 2', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}]}, {'type': 'Mid-point Visit (Treatment Week-3)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}]}, {'type': 'Sleep Study 3', 'achievements': [{'comment': '1 subject could not complete sleep study 3 due to hospital-wide shut-downs during the COVID pandemic.', 'groupId': 'FG000', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Subjects recruited from clinics and clinician referrals at the Michael E. DeBakey VA Medical Center', 'preAssignmentDetails': 'Pre-assignment exclusions (n=5): non-adherent to CPAP (n=2), bradycardia and hepatic dysfunction (n=1), psychosis (n=1), lost to follow up (n=1)'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Open-label Treatment', 'description': 'pimavanserin 34mg at bedtime for 6 weeks\n\nPimavanserin: pimavanserin tablet'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '35.33', 'spread': '6.35', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Current depressive disorder', 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Current depressive disorder per the Structured Clinical Interview for the DSM-5', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Subjects enrolled into open-label treatment'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-08-20', 'size': 5711748, 'label': 'Study Protocol, Statistical Analysis Plan, and Informed Consent Form', 'hasIcf': True, 'hasSap': True, 'filename': 'Prot_SAP_ICF_000.pdf', 'typeAbbrev': 'Prot_SAP_ICF', 'uploadDate': '2022-07-20T21:47', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2021-11-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-10', 'studyFirstSubmitDate': '2019-12-04', 'resultsFirstSubmitDate': '2022-07-20', 'studyFirstSubmitQcDate': '2019-12-04', 'lastUpdatePostDateStruct': {'date': '2022-08-31', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-08-10', 'studyFirstPostDateStruct': {'date': '2019-12-05', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-08-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recruitment Rates', 'timeFrame': 'Total duration of recruitment time (5.8 months)', 'description': 'The rate of enrollment per month; goal of 6 subjects total'}, {'measure': 'Retention Rates', 'timeFrame': '10 weeks (overall study)', 'description': 'The number of subjects who complete the protocol in its entirety; goal of 75% of subjects enrolled into treatment'}], 'secondaryOutcomes': [{'measure': 'Mean Change in Duration of Stage N3 Sleep Pre- and Post-treatment', 'timeFrame': '6 weeks (time between baseline and closeout polysomnogram)', 'description': 'The mean difference in duration of stage N3 sleep from baseline polysomnogram to week-6 polysomnogram (\\[Time in N3 post-treatment\\] - \\[Time in N3 at baseline polysomnogram\\])'}, {'measure': 'Discontinuation Rates Due to Adverse Effects', 'timeFrame': '10 weeks (overall study duration)', 'description': 'The number of subjects who discontinue the protocol due to adverse effects (from either protocol or medication)'}, {'measure': 'Completion Rates of Key Outcome Measures', 'timeFrame': '10 weeks (overall study duration)', 'description': 'The percentage of participants who complete subject and objective measures of insomnia, including sleep diaries, actigraphy, and attended polysomnography'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Post-traumatic Stress Disorder', 'Insomnia'], 'conditions': ['Post-traumatic Stress Disorder', 'Insomnia']}, 'descriptionModule': {'briefSummary': 'This preliminary, open-label study assesses the feasibility of 34mg at bedtime for 6 weeks in Veterans with Posttraumatic Stress Disorder and insomnia.', 'detailedDescription': "More treatments are needed to target insomnia in Veterans with Posttraumatic Stress Disorder. There is evidence to suggest that pimavanserin, a medication approved by the Food and Drug Administration for the treatment of psychosis in Parkinson's disease, may improve deep sleep and insomnia. This study preliminary assesses the feasibility of pimavanserin 34mg at bedtime for 6 weeks for the treatment of chronic insomnia in Veterans with Posttraumatic Stress Disorder."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Meets criteria for current Posttraumatic Stress Disorder (PTSD), as per a total score of ≥33 on the PTSD Checklist (PCL-5) and Diagnostic and Statistical Manual of Mental Disorders-Fifth Edition (DSM-5) criteria for PTSD.\n* Meets DSM-5 standards of chronic insomnia disorder, as follows: a. Complains of dissatisfaction with nighttime sleep in the form of difficulty falling asleep (subjective sleep onset latency ≥30 minutes), difficulty staying asleep (subjective time awake after sleep onset ≥30 minutes), and/or awakening earlier in the morning (≥30 minutes before scheduled wake time and before a total sleep time of 6.5 hours) than desired. b. Insomnia frequency of ≥3 times per week c. The duration of the insomnia complaint is ≥3 months d. Associated with complaint of daytime impairment.\n* Insomnia Severity Index total score ≥15 (moderate insomnia).\n* Willing to not start a concurrent behavioral or other treatment program for insomnia, PTSD, or other psychiatric disorders during the participation in the study.\n* Women of child-bearing potential who are sexually active agree to use two methods of contraception for the duration of the study and extending to 30 days after the last dose of study drug.\n\nExclusion Criteria:\n\n* Current or a history of a primary psychotic disorder (i.e., schizophrenia, schizoaffective or bipolar disorder)\n* Active suicidal or homicidal ideation requiring crisis intervention\n* Current moderate or severe alcohol or marijuana use disorder, or other illicit use disorder of any severity\n* A history of moderate or severe traumatic brain injury or other neurological illness (i.e., stroke, epilepsy, multiple sclerosis);\n* Caffeine use that is deemed excessive and is contributing to the insomnia per the opinion of the investigators (i.e. caffeinated beverages consumed after 18:00 3 times/week or more and/or that correlates with the timing of the insomnia complaints).\n* Tobacco use before bedtime that is contributing to the insomnia per the opinion of the investigators or that would interfere with completing an overnight polysomnogram.\n* Previous diagnosis of periodic limb movement disorder, restless legs syndrome, circadian rhythm sleep disorder, narcolepsy, Rapid Eye Movement Behavior Disorder, or other sleep disorders (except obstructive sleep apnea) that may confound, per the opinion of the investigators, the assessment of insomnia.\n* Previous diagnosis of moderate to severe obstructive sleep apnea (defined as an AHI equal to or greater than 15)\n* Participants deemed to be at high risk of moderate to severe obstructive sleep apnea per the Snoring, Tiredness, Observed apnea, high blood Pressure, Body mass index, Age, Neck circumference, and male Gender questionnaire (STOP-BANG). Subjects with a STOP-BANG score of 5 or greater, or STOP score of 2 or greater plus body mass index greater than 35 kg/m2 or male or neck circumference greater than 40 cm, are considered to be high-risk. These participants can re-enter the study following adherence to therapy for 1-month and if inclusion and exclusion criteria are still met.\n* Participants identified as having moderate to severe obstructive sleep apnea during the screening polysomnogram. These participants will be referred to clinical treatment\n* Periodic limb movement arousal index 15 or greater or other sleep disorders captured during the screening polysomnogram that may confound, per the opinion of the investigators, the assessment and treatment of insomnia\n* A prolonged QT interval, corrected for heart rate (QTc), at the screening electrocardiogram. A prolonged QTc is defined as 470 milliseconds for males and 480 milliseconds for females.\n* Engagement in an evidence-based psychotherapy for 1-week prior to enrollment that in the opinion of the investigators, may confound the assessment of insomnia\n* Current evidence of clinically significant cardiac, respiratory, gastrointestinal, renal, neurological, hepatic, and/or chronic pain that in the opinion of the investigator(s) could affect the participant's safety or interfere with the study assessments\n* Females who are breastfeeding or pregnant at screening\n* Females of childbearing potential who are not practicing acceptable pregnancy prevention methods (NOTE: All females will be considered to be of childbearing potential unless they are postmenopausal or have been sterilized surgically).\n* Current use of a prohibited medications: Hypnotic or sedating medications taken at bedtime for insomnia; antipsychotics and antidepressants with known 5HT2A antagonist activity; medications that increase or decrease the metabolism of pimavanserin; medications that increase the risk of QTc prolongation\n* Patients with conditions known to increase the risk of torsades de pointes and/or sudden death, such as symptomatic bradycardia and other cardiac arrhythmias, uncorrected hypokalemia or hypomagnesemia, and congenital prolongation of the QT interval."}, 'identificationModule': {'nctId': 'NCT04188392', 'acronym': 'PIP', 'briefTitle': 'Pimavanserin for Insomnia In Veterans With Posttraumatic Stress Disorder', 'organization': {'class': 'OTHER', 'fullName': 'Baylor College of Medicine'}, 'officialTitle': 'Pilot Feasibility Study of Pimavanserin for Insomnia in Veterans With Posttraumatic Stress Disorder', 'orgStudyIdInfo': {'id': 'H-45799'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'open-label treatment', 'description': 'pimavanserin 34mg at bedtime for 6 weeks', 'interventionNames': ['Drug: Pimavanserin']}], 'interventions': [{'name': 'Pimavanserin', 'type': 'DRUG', 'otherNames': ['Nuplazid'], 'description': 'pimavanserin tablet', 'armGroupLabels': ['open-label treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Michael E. DeBakey VA Medical Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Melissa B Jones, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Michael E. DeBakey VA Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Patient health information will not be transmitted to collaborators.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Baylor College of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Melissa Jones', 'investigatorAffiliation': 'Baylor College of Medicine'}}}}