Ignite Creation Date:
2025-12-25 @ 2:04 AM
Ignite Modification Date:
2025-12-26 @ 12:29 AM
Study NCT ID:
NCT07220460
Status:
RECRUITING
Last Update Posted:
2025-12-23
First Post:
2025-09-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Assess the Adverse Events of Oral ABBV-932 in Adult Participants With Depressive Episodes Associated With Bipolar I or II Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-09-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2027-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-20', 'studyFirstSubmitDate': '2025-09-26', 'studyFirstSubmitQcDate': '2025-10-22', 'lastUpdatePostDateStruct': {'date': '2025-12-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-10-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Experiencing Adverse Events', 'timeFrame': 'Up to approximately 29 weeks', 'description': 'An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.'}, {'measure': 'Number of Participants with Abnormal Change From Baseline in Vital Sign Measurements', 'timeFrame': 'Up to week 26', 'description': 'Number of participants with abnormal change from baseline in vital sign measurements like systolic and diastolic blood pressure will be assessed.'}, {'measure': 'Number of Participants with Change from Baseline in Electrocardiogram (ECG)', 'timeFrame': 'Up to week 26', 'description': '12-lead resting ECG will be recorded.'}, {'measure': 'Number of Participants with Abnormal Change in Clinical Laboratory Test Results Like Hematology will be Assessed', 'timeFrame': 'Up to week 26', 'description': 'Number of participants with abnormal change in clinical laboratory test results like hematology will be assessed.'}, {'measure': 'Change From Baseline in Simpson-Angus Scale (SAS)', 'timeFrame': 'Up to week 26', 'description': 'SAS (Simpson-Angus Scale): is a 10-item rating scale for assessment of antipsychotic-induced parkinsonism in both clinical practice and research settings. Minimum: 0 (no symptoms) Maximum: 40 (very severe symptoms; 10 items scored 0-4 each).'}, {'measure': 'Change From Baseline in Abnormal Involuntary Movement Scale (AIMS)', 'timeFrame': 'Up to week 26', 'description': "AIMS (Abnormal Involuntary Movement Scale): assesses abnormal involuntary movements, such as tardive dyskinesia, associated with antipsychotic drugs; it measures facial, oral, extremities, and trunk movements, as well as the participant's awareness of abnormal movements. Minimum: 0 (no abnormal movements) Maximum: 42 (most severe; 7 items scored 0-4 each), some versions use 0-4 on 10 items for a max of 40/40."}, {'measure': 'Change From Baseline in Barnes Akathisia Rating Scale (BARS)', 'timeFrame': 'Up to week 26', 'description': 'BARS (Barnes Akathisia Rating Scale): is a 4-item rating scale used to assess drug-induced akathisia. The scale comprises items for rating the observable restless movements that characterize the condition, the subjective awareness of restlessness, and any distress associated with the akathisia. Minimum: 0 (no akathisia) Maximum: 14 (severe akathisia; 4 items scored, most items 0-3 or 0-5)'}, {'measure': 'Change from Baseline in Columbia-Suicide Severity Rating Scale (C-SSRS)', 'timeFrame': 'Up to week 26', 'description': 'C-SSRS rates an individual\'s degree of suicidal ideation (SI) and behaviors on a scale, ranging from "wish to be dead" to "active suicidal ideation with specific plan and intent."'}, {'measure': 'Change From Baseline in the Epworth Sleepiness Scale (ESS)', 'timeFrame': 'Up to week 26', 'description': 'ESS (Epworth Sleepiness Scale): is a scale that is intended to measure daytime sleepiness. Minimum: 0 (no sleepiness) Maximum: 24 (severe sleepiness; 8 items scored 0-3 each)'}, {'measure': 'Change From Baseline in the Young Mania Rating Scale (YMRS)', 'timeFrame': 'Up to week 26', 'description': "The YMRS (Young Mania Rating Scale): is an 11-item, clinician-rated scale that assesses manic symptoms based on the participant's perception of their condition over the previous 48 hours, as well as the physician's clinical observations during the interview. Minimum: 0 (no mania) Maximum: 60 (severe mania; 11 items, some scored 0-4, others 0-8)"}, {'measure': 'Number of Participants with Abnormal Change in Ocular Examination', 'timeFrame': 'Up to week 26', 'description': 'Number of participants with abnormal change in ocular examinations in areas like best corrected visual acuity (BCVA), and refraction.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Bipolar I or II Disorder'], 'conditions': ['Bipolar I or II Disorder']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.abbvieclinicaltrials.com/study/?id=M25-456', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'Bipolar disorder is a severe chronic mood disorder that affects up to 4% of the adult population in the United States. The purpose of this study is to assess how safe and effective ABBV-932 is in treating participants with depressive episodes associated with bipolar I or II disorder.\n\nABBV-932 is an investigational drug being developed for the treatment of depressive episodes in adult participants with bipolar I or II disorder. Participants with bipolar I or II disorder who are currently experiencing a depressive episode will enter the study and be treated with open-label ABBV-932. Approximately 200 adult participants with bipolar I or II disorder will be enrolled in approximately 50 sites in the United States and Puerto Rico.\n\nParticipants will receive oral capsules of ABBV-932 for a 26-week treatment period. The treatment period will be followed by a safety follow-up (SFU) period of 30 days.\n\nThere may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regularly scheduled visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Body Mass Index (BMI) ≥ 18.0 to ≤ 40.0 kg/m\\^2, inclusive.\n* Participants who currently meet the Diagnostic and Statistical Manual of Mental Disorders treatment (DSM-5-TR) criteria for bipolar I or II disorder without psychotic features based on the Mini International Neuropsychiatric Interview (MINI 7.0.2), currently experiencing a depressive episode of at least 4 weeks and not exceeding 12 months.\n* Normal physical examination findings, clinical laboratory test results, vital signs, and 12-lead ECG results at screening or abnormal results that are judged not clinically significant by the investigator and documented as such in the eCRF\n* Participant with the following psychiatric history:\n\n * No history of psychiatric hospitalization (inpatient or intensive outpatient) in the past 3 months prior to screening.\n * No lifetime history of schizophrenia, other psychotic disorders, dissociative disorders, or neurocognitive disorders.\n * No history of moderate or severe substance use disorder (except nicotine) in the past 6 months prior to screening.\n\nExclusion Criteria:\n\n* A total score greater than 12 on the Young Mania Rating Scale (YMRS) at baseline.\n* History of an allergic reaction or significant sensitivity to constituents of the study drug (and its excipients) and/or other products in the same class.\n* A concurrent medical condition that might interfere with the conduct of the study, confound the interpretation of the study results, or endanger the subject's well-being. This includes any unstable condition, history or evidence of malignancy (other than treated basal or squamous cell carcinoma), or any significant hematologic, endocrine, cardiovascular, respiratory, renal impairment or disease (subjects with eGFR \\< 30 mL/min), hepatic (including history of severe hepatic impairment), gastrointestinal, or neurological disorder (if there is a history of such disease but the condition has been stable for more than 1 year, does not require treatment with prohibited medications, and is judged by the investigator not to interfere with participation in the study, the subject may be included in the study)."}, 'identificationModule': {'nctId': 'NCT07220460', 'briefTitle': 'Study to Assess the Adverse Events of Oral ABBV-932 in Adult Participants With Depressive Episodes Associated With Bipolar I or II Disorder', 'organization': {'class': 'INDUSTRY', 'fullName': 'AbbVie'}, 'officialTitle': 'Multicenter, Open-label Study to Evaluate the Long-term Safety and Tolerability of ABBV-932 in Subjects With Depressive Episodes Associated With Bipolar I or II Disorder', 'orgStudyIdInfo': {'id': 'M25-456'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ABBV-932', 'description': 'Participants will receive oral ABBV-932 for a 26-week treatment period followed by a 30-day follow-up', 'interventionNames': ['Drug: ABBV-932']}], 'interventions': [{'name': 'ABBV-932', 'type': 'DRUG', 'description': 'Oral Capsule', 'armGroupLabels': ['ABBV-932']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85012', 'city': 'Phoenix', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Ima Clinical Research Phoenix (Alea) /ID# 278047', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '92805', 'city': 'Anaheim', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Advanced Research Center /ID# 273474', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'zip': '92324', 'city': 'Colton', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Axiom Research /ID# 273482', 'geoPoint': {'lat': 34.0739, 'lon': -117.31365}}, {'zip': '92845', 'city': 'Garden Grove', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Collaborative Neuroscience Research - Garden Grove /ID# 273492', 'geoPoint': {'lat': 33.77391, 'lon': -117.94145}}, {'zip': '92251', 'city': 'Imperial', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Sun Valley Research Center /ID# 273472', 'geoPoint': {'lat': 32.84755, 'lon': -115.56944}}, {'zip': '91945', 'city': 'Lemon Grove', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Synergy San Diego /ID# 278340', 'geoPoint': {'lat': 32.74255, 'lon': -117.03142}}, {'zip': '90807', 'city': 'Long Beach', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Alliance for Research Alliance for Wellness /ID# 273477', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'zip': '92056', 'city': 'Oceanside', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Excell Research /ID# 273483', 'geoPoint': {'lat': 33.19587, 'lon': -117.37948}}, {'zip': '92591', 'city': 'Temecula', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Viking Clinical Research Center - Temecula /ID# 273471', 'geoPoint': {'lat': 33.49364, 'lon': -117.14836}}, {'zip': '94596', 'city': 'Walnut Creek', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Sunwise Clinical Research /ID# 278165', 'geoPoint': {'lat': 37.90631, 'lon': -122.06496}}, {'zip': '06416', 'city': 'Cromwell', 'state': 'Connecticut', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Connecticut Clinical Research - Cromwell /ID# 278116', 'geoPoint': {'lat': 41.5951, 'lon': -72.64537}}, {'zip': '32256', 'city': 'Jacksonville', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Cns Healthcare - Jacksonville /ID# 278332', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '33125', 'city': 'Miami', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'GMI Florida - Central Miami Medical Institute /ID# 273486', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33155', 'city': 'Miami', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Allied Biomedical Res Inst Inc /ID# 273476', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '32751', 'city': 'Orlando', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'K2 Medical Research - Orlando - South Orlando Avenue /ID# 273487', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '32803', 'city': 'Orlando', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Apg Research /ID# 278439', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '33319-4985', 'city': 'Tamarac', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Segal Trials - West Broward Outpatient Research Site /ID# 273496', 'geoPoint': {'lat': 26.21286, 'lon': -80.24977}}, {'zip': '71101', 'city': 'Shreveport', 'state': 'Louisiana', 'status': 'COMPLETED', 'country': 'United States', 'facility': 'Benchmark Research /ID# 273490', 'geoPoint': {'lat': 32.52515, 'lon': -93.75018}}, {'zip': '01103', 'city': 'Springfield', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Elixia, LLC /ID# 278446', 'geoPoint': {'lat': 42.10148, 'lon': -72.58981}}, {'zip': '63125', 'city': 'St Louis', 'state': 'Missouri', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Arch Clinical Trials /ID# 273481', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '89102', 'city': 'Las Vegas', 'state': 'Nevada', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Ima Clinical Research Las Vegas (Altea) /ID# 278054', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '08755', 'city': 'Toms River', 'state': 'New Jersey', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Bio Behavioral Health /ID# 273478', 'geoPoint': {'lat': 39.95373, 'lon': -74.19792}}, {'zip': '11229', 'city': 'Brooklyn', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Integrative Clinical Trials /ID# 278040', 'geoPoint': {'lat': 40.6501, 'lon': -73.94958}}, {'zip': '11516', 'city': 'Cedarhurst', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Neurobehavioral Research /ID# 273470', 'geoPoint': {'lat': 40.62288, 'lon': -73.7243}}, {'zip': '28211', 'city': 'Charlotte', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'New Hope Clinical Research - Inpatient unit /ID# 273468', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '44012', 'city': 'Avon Lake', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Quest Therapeutics of Avon Lake /ID# 273484', 'geoPoint': {'lat': 41.50532, 'lon': -82.0282}}, {'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'OSU Psychiatry Department /ID# 273495', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '73116', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Sooner Clinical Research /ID# 273491', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '97210', 'city': 'Portland', 'state': 'Oregon', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Summit Research Network - Portland - Northwest Vaughn Street /ID# 278084', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '18103', 'city': 'Allentown', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Lehigh Center for Clinical Research /ID# 273466', 'geoPoint': {'lat': 40.60843, 'lon': -75.49018}}, {'zip': '77407', 'city': 'Richmond', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Perceptive Pharma Research /ID# 273485', 'geoPoint': {'lat': 29.58218, 'lon': -95.76078}}, {'zip': '98007', 'city': 'Bellevue', 'state': 'Washington', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Northwest Clinical Research Center /ID# 273480', 'geoPoint': {'lat': 47.61038, 'lon': -122.20068}}, {'zip': '00918-3014', 'city': 'San Juan', 'status': 'RECRUITING', 'country': 'Puerto Rico', 'facility': 'INSPIRA Clinical Research /ID# 274670', 'geoPoint': {'lat': 18.46633, 'lon': -66.10572}}], 'centralContacts': [{'name': 'ABBVIE CALL CENTER', 'role': 'CONTACT', 'email': 'abbvieclinicaltrials@abbvie.com', 'phone': '844-663-3742'}], 'overallOfficials': [{'name': 'ABBVIE INC.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AbbVie'}]}, 'ipdSharingStatementModule': {'url': 'https://vivli.org/ourmember/abbvie/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/', 'ipdSharing': 'YES', 'description': 'AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.', 'accessCriteria': 'To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AbbVie', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}