Ignite Creation Date:
2025-12-25 @ 4:29 AM
Ignite Modification Date:
2026-02-28 @ 9:32 AM
Study NCT ID:
NCT01587118
Status:
COMPLETED
Last Update Posted:
2019-06-11
First Post:
2012-04-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
An Open Label Pilot Study of Adjunctive Asenapine for the Treatment of Posttraumatic Stress Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013313', 'term': 'Stress Disorders, Post-Traumatic'}], 'ancestors': [{'id': 'D040921', 'term': 'Stress Disorders, Traumatic'}, {'id': 'D000068099', 'term': 'Trauma and Stressor Related Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C522667', 'term': 'asenapine'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'sandra.creel@va.gov', 'phone': '205-554-2000', 'title': 'Sandra Creel', 'phoneExt': '1-2840', 'organization': 'Tuscaloosa Research and Education Advancement Corp'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'This study was limited by both the small number of subjects enrolled and its open-label design.\n\nAverage dose of asenapine was 13.6 ± 6.4 mg/d; at 12-weeks 15.9 ± 4.9 mg/d.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected for the 12 weeks of active study participation; Serious adverse events were collected for the 12 weeks of study and one additional post-study month.', 'eventGroups': [{'id': 'EG000', 'title': 'Antidepressant Plus Asenapine', 'description': 'adjunctive asenapine\n\nAdjunctive asenapine: participants who are not responding fully to antidepressant therapy for PTSD will receive adjunctive asenapine (flexible dosing beginning with 5 mg sublingual once per day, titrated up to 10 mg twice per day, as tolerated) for a total of 12 weeks.', 'otherNumAtRisk': 18, 'otherNumAffected': 6, 'seriousNumAtRisk': 18, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'sedation with syncope', 'notes': 'sedation with syncope day 1 while on asenapine 5mg/d; stopped study medication.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'weight gain', 'notes': 'weight gain at week 4 on 5mg/d asenapine; stopped asenapine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'sedation', 'notes': 'sedation at week 4 in one participant and sedation at week 12 in one participant; both stopped asenapine.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'extrapyramidal side effect', 'notes': 'extrapyramidal side effects at week 12 on 20mg/d asenapine; stopped asenapine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Headache', 'notes': 'On 10mg/d asenapine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'sinus infection', 'notes': 'Unrelated to asenapine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'upset stomach', 'notes': 'asenapine 10mg/d', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'fatigue', 'notes': '10mg/d asenapine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'agitation', 'notes': 'day 4 on 5mg/d asenapine, stopped asenapine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}], 'seriousEvents': [{'term': 'Psychiatric hospitalization', 'notes': 'One participant was hospitalized on psychiatric unit in the month following study exit while not on asenapine; Unrelated SAE.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Clinical Administered PTSD Scale (CAPS) Total', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Antidepressant Plus Asenapine', 'description': 'adjunctive asenapine\n\nAdjunctive asenapine: participants who are not responding fully to antidepressant therapy for PTSD will receive adjunctive asenapine (flexible dosing beginning with 5 mg sublingual once per day, titrated up to 10 mg twice per day, as tolerated) for a total of 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-39', 'spread': '18.4', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<.0001', 'groupIds': ['OG000'], 'pValueComment': 'The a priori threshold for statistical significance was p\\</= 0.05', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Change from baseline analyses were conducted using simple one-way analysis of variance; and were recalculated using the Kruskal Wallis procedure.'}], 'paramType': 'MEAN', 'timeFrame': 'baseline, week 4, 8, and 12', 'description': 'CAPS is the clinician rating of posttraumatic stress disorder (PTSD) symptoms; higher scores indicate higher severity of PTSD; 17-item score range 0 to 136. Blake DD, Weathers FW, Nagy LM, et al. The development of a Clinician-Administered PTSD Scale. J Trauma Stress 1995; 8:75-90.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Open label treatment, all participants included.Overall change in values from baseline to week 12, including weeks 4 and 8, using a simple one-way analysis of variance; because the sample size was small, p-values for the paired t-test and one-way results were recalculated using the signed rank test and Kruskal Wallis procedure, respectively'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Brief Psychiatric Rating Scale (BPRS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Antidepressant Plus Asenapine', 'description': 'adjunctive asenapine\n\nAdjunctive asenapine: participants who are not responding fully to antidepressant therapy for PTSD will receive adjunctive asenapine (flexible dosing beginning with 5 mg sublingual once per day, titrated up to 10 mg twice per day, as tolerated) for a total of 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-15.5', 'spread': '9.3', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '.0006', 'groupIds': ['OG000'], 'pValueComment': 'The a priori threshold for statistical significance was p\\</= 0.05', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Change from baseline analyses were conducted using simple one-way analysis of variance; and were recalculated using the Kruskal Wallis procedure.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, week 4, 8, 12', 'description': 'BPRS is the clinician rating of psychiatric symptoms; higher score indicates higher severity; 18-items scored 1-7; highest score 126. Overall JE and Gorham DR. The Brief Psychiatric Rating Scale (BPRS): recent developments in ascertainment and scaling. Psychopharmacol Bulletin 1993; 24:97-99.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Open label treatment, all participants included.Overall change in values from baseline to week 12, including weeks 4 and 8, using a simple one-way analysis of variance; because the sample size was small, p-values for the paired t-test and one-way results were recalculated using the signed rank test and Kruskal Wallis procedure, respectively'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Antidepressant Plus Asenapine', 'description': 'adjunctive asenapine\n\nAdjunctive asenapine: participants who are not responding fully to antidepressant therapy for PTSD will receive adjunctive asenapine (flexible dosing beginning with 5 mg sublingual once per day, titrated up to 10 mg twice per day, as tolerated) for a total of 12 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': '31 signed consent and 18 were deemed eligible and initiated treatment with adjunctive asenapine.', 'groupId': 'FG000', 'numSubjects': '18'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Relocation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'nonresponse', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Antidepressant Plus Asenapine', 'description': 'adjunctive asenapine\n\nAdjunctive asenapine: participants who are not responding fully to antidepressant therapy for PTSD will receive adjunctive asenapine (flexible dosing beginning with 5 mg sublingual once per day, titrated up to 10 mg twice per day, as tolerated) for a total of 12 weeks.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '48.3', 'spread': '11.9', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '15', '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': '11', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', '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': '18', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-06-03', 'studyFirstSubmitDate': '2012-04-25', 'resultsFirstSubmitDate': '2016-07-18', 'studyFirstSubmitQcDate': '2012-04-26', 'lastUpdatePostDateStruct': {'date': '2019-06-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-10-12', 'studyFirstPostDateStruct': {'date': '2012-04-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-12-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Clinical Administered PTSD Scale (CAPS) Total', 'timeFrame': 'baseline, week 4, 8, and 12', 'description': 'CAPS is the clinician rating of posttraumatic stress disorder (PTSD) symptoms; higher scores indicate higher severity of PTSD; 17-item score range 0 to 136. Blake DD, Weathers FW, Nagy LM, et al. The development of a Clinician-Administered PTSD Scale. J Trauma Stress 1995; 8:75-90.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Brief Psychiatric Rating Scale (BPRS)', 'timeFrame': 'Baseline, week 4, 8, 12', 'description': 'BPRS is the clinician rating of psychiatric symptoms; higher score indicates higher severity; 18-items scored 1-7; highest score 126. Overall JE and Gorham DR. The Brief Psychiatric Rating Scale (BPRS): recent developments in ascertainment and scaling. Psychopharmacol Bulletin 1993; 24:97-99.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['PTSD', 'Posttraumatic Stress Disorder', 'Asenapine', 'Adjunctive', 'antidepressant', 'neuroleptic'], 'conditions': ['Posttraumatic Stress Disorder']}, 'referencesModule': {'references': [{'pmid': '27738377', 'type': 'RESULT', 'citation': 'Pilkinton P, Berry C, Norrholm S, Bartolucci A, Birur B, Davis LL. An Open Label Pilot Study of Adjunctive Asenapine for the Treatment of Posttraumatic Stress Disorder. Psychopharmacol Bull. 2016 Aug 15;46(2):8-17. doi: 10.64719/pb.4349.'}]}, 'descriptionModule': {'briefSummary': 'This is an open-label pilot study of adjunctive asenapine for the treatment of Posttraumatic Stress Disorder (PTSD) in veterans who have not fully remitted to an adequate trial of standard antidepressant treatment.', 'detailedDescription': 'Consenting Veterans with the diagnosis of PTSD who have not fully remitted to an adequate trial of standard antidepressant treatment (sertraline, citalopram, escitalopram, fluoxetine, venlafaxine, or mirtazapine) are treated with the addition of open-label asenapine for 12-weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Signed and dated informed consent and acceptable proof of identity.\n* Male or female subjects ≥19 to 65 years of age of any race or ethnic origin.\n* Not currently pregnant, breastfeeding or planning on becoming pregnant; use of contraception as follows:\n* Males - those that are sexually active must use a double barrier method of contraception (condom with spermicide) from the first dose of asenapine until 12 weeks after last dose of asenapine\n* Women of child-bearing potential - must have a negative urine pregnancy test and confirmed (by the investigator) use of a highly effective form of birth control for 3 months before enrollment and until 12 weeks after their last dose of asenapine.\n* Women of non-child bearing potential - women who are either permanently sterilized (hysterectomy, bilateral oophorectomy and bilateral salpingectomy but excluding bilateral tubal occlusion) or who are postmenopausal.\n* Diagnosis of PTSD (DSM-IV-TR criteria; confirmed by MINI and CAPS).\n* Total CAPS score \\> 45.\n* Currently taking an approved antidepressant at acceptable dose for 8 weeks or more with non-remission of symptoms.\n* No substance use disorders of dependence (except for nicotine, caffeine) in previous 4 wks.\n* No substance use disorders of abuse (except for nicotine and caffeine) in the previous 2 wks.\n* Physical and laboratory panel (within past one year) are within normal limits or not clinically significant\n\nExclusion Criteria:\n\n* Lifetime history of bipolar I, schizophrenia, schizoaffective or cognitive disorders (assessed by the MINI)\n* Actively considering plans of suicide or homicide (assessed by clinical interview)\n* Psychotic symptoms that in the investigator's opinion impair the subject's ability to give informed consent\n* A contraindication to the use of asenapine or antidepessant\n* Intolerable side effects or allergic reaction to asenapine or the current antidepressant\n* Women planning to become pregnant or breastfeed during the study\n* Clinically significant unstable or severe medical condition that would contraindicate study participation or expose them to an undue risk of a significant adverse event, including but not limited to: unstable or severe hepatic, renal, respiratory, cardiovascular, endocrine, neurologic, or hematologic disease; hypo- or hyperthyroidism, unless the condition has been stabilized; or a history of seizures (except for a single childhood febrile seizure, posttraumatic, or alcohol withdrawal). The following are exclusionary: platelets \\< 75,000/mm; hemoglobin \\<9g/dL; neutrophils, absolute \\< 1000/mm; LFTs \\> 3x upper limit; creatinine \\> 2 mg/dL; diastolic BP \\< 60 or \\> 110mmHg; EKG QTc \\> 475 msec.\n* In regard to vulnerable patient populations, persons with dementia, minors (\\<age 19), the elderly (\\>age 65), prisoners and the terminally ill are excluded."}, 'identificationModule': {'nctId': 'NCT01587118', 'briefTitle': 'An Open Label Pilot Study of Adjunctive Asenapine for the Treatment of Posttraumatic Stress Disorder', 'organization': {'class': 'OTHER', 'fullName': 'Tuscaloosa Research & Education Advancement Corporation'}, 'officialTitle': 'An Open Label Pilot Study of Adjunctive Asenapine for the Treatment of Posttraumatic Stress Disorder', 'orgStudyIdInfo': {'id': '00156'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'antidepressant plus asenapine', 'description': 'adjunctive asenapine', 'interventionNames': ['Drug: Adjunctive asenapine']}], 'interventions': [{'name': 'Adjunctive asenapine', 'type': 'DRUG', 'otherNames': ['asenapine', 'Saphris'], 'description': 'participants who are not responding fully to antidepressant therapy for PTSD will receive adjunctive asenapine (flexible dosing beginning with 5 mg sublingual once per day, titrated up to 10 mg twice per day, as tolerated) for a total of 12 weeks.', 'armGroupLabels': ['antidepressant plus asenapine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35404', 'city': 'Tuscaloosa', 'state': 'Alabama', 'country': 'United States', 'facility': 'Tuscaloosa VA Medical Center', 'geoPoint': {'lat': 33.20984, 'lon': -87.56917}}], 'overallOfficials': [{'name': 'Lori L Davis, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tuscaloosa Research & Education Advancement Corporation'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No sharing of individual participant data'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lori Davis, MD', 'class': 'OTHER'}, 'collaborators': [{'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, {'name': 'Forest Laboratories', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Associate Chief of Staff, Research and Development Service', 'investigatorFullName': 'Lori Davis, MD', 'investigatorAffiliation': 'Tuscaloosa Research & Education Advancement Corporation'}}}}