Ignite Creation Date:
2025-12-25 @ 12:54 AM
Ignite Modification Date:
2026-01-01 @ 3:24 AM
Study NCT ID:
NCT06256367
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-09-23
First Post:
2024-02-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Observational Study of Oral Cariprazine Capsules to Assess Change in Disease Activity in Adult Participants With Bipolar I Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 170}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-04-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-22', 'studyFirstSubmitDate': '2024-02-05', 'studyFirstSubmitQcDate': '2024-02-05', 'lastUpdatePostDateStruct': {'date': '2025-09-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-02-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline on Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score', 'timeFrame': 'Up to Week 12', 'description': 'MADRS is a 10-item questionnaire that is rated by investigators to assess changes in depression symptoms over the past week. The individual items (apparent sadness, reported sadness, feelings of tension, reduced appetite, reduced sleep, lassitude, concentration difficulties, pessimistic thoughts, inability to feel emotions, and suicidal thoughts) are scored from 0 (no symptoms) to 6 (maximum severity) and summed for the total score (range 0 to 60). Higher scores indicate more severe depression.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline on Functioning Assessment Short Test (FAST) Total Score', 'timeFrame': 'Up to Week 12', 'description': 'The FAST is comprised of 24 items and assesses disability or impairment in 6 domains: autonomy, occupational functioning, financial issues, interpersonal relationships, cognitive functioning, and leisure time. FAST is administered by the investigator as an interview. Items are rated using a 4-point scale, from 0 (no difficulty) to 3 (severe difficulty) then summed for a total score. Higher scores indicate more severe impairment.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Bipolar I Disorder', 'Cariprazine', 'CReW BP-I'], 'conditions': ['Bipolar I Disorder']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.abbvieclinicaltrials.com/study/?id=P24-477', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': "Bipolar I disorder (BP-I) is a common, chronic, and disabling mental illness with significant morbidity and mortality defined by episodes of mania and depression (or symptoms of both at once, known as mixed features). This prospective, observational study will examine effectiveness, functioning and quality of life outcomes in adult patients with BP-I experiencing a major depressive episode (with or without mixed features) requiring treatment and initiating treatment with cariprazine. It will examine outcomes of cariprazine treatment in a real-world setting in patients with BP-I commonly seen in clinical practices.\n\nCariprazine (Vraylar) is a medication indicated in the United States and Canada to treat adult patients experiencing manic, mixed or depressive episodes associated with BP-I. This study plans to enroll approximately 170 adult patients with BP-I from the United States and Canada. Cariprazine should be prescribed by the physician under the usual and customary practice of physician prescription. The decision to initiate treatment with cariprazine should be made prior to, and independently from, the patient's decision to participate in the study.\n\nParticipants will receive cariprazine as prescribed by their physician. Observational data will be collected during visits which should align to routine standard of care for a duration of up to 24 weeks."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with a bipolar I disorder diagnosis experiencing a major depressive episode (with or without mixed features) requiring treatment and being prescribed cariprazine by their physician; irrespective of study participation.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have a physician-confirmed diagnosis of BP-I, with or without comorbidities.\n* Prescribed cariprazine as part of routine clinical practice with the intention of treating as per the approved market label, respective country indications, and by the physician under usual and customary practice of physician prescription.\n* Have a Montgomery-Åsberg Depression Rating Scale (MADRS) score \\>= 20 at baseline.\n* Have a Functioning Assessment Short Test (FAST) score \\>= 21 at baseline.\n* Naïve to cariprazine in the current major depressive episode.\n\nExclusion Criteria:\n\n* Have a medical or psychiatric condition, or planned surgical procedure, which will interfere with study participation, as judged by the investigator.\n* Have a known contraindication to cariprazine including any of the following:\n\n * Hypersensitivity to cariprazine or any ingredient in the formulation\n * For all sites, concomitant use of strong cytochrome P450 (CYP) 3A4 inhibitors and inducers\n * For Canadian sites, as per country label, concomitant use of moderate CYP 3A4 inhibitors and inducers\n* Current major depressive episode duration \\> 12 months.'}, 'identificationModule': {'nctId': 'NCT06256367', 'acronym': 'CReW BP-I', 'briefTitle': 'Observational Study of Oral Cariprazine Capsules to Assess Change in Disease Activity in Adult Participants With Bipolar I Disorder', 'organization': {'class': 'INDUSTRY', 'fullName': 'AbbVie'}, 'officialTitle': 'Cariprazine Real-world Use in Bipolar I Disorder: Effectiveness, Functioning, Quality of Life, and Tolerability', 'orgStudyIdInfo': {'id': 'P24-477'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cariprazine', 'description': 'Participants will receive cariprazine as prescribed by their physician in routine clinical practice. The decision to initiate cariprazine should be made prior to, and independently from, the decision to participate in this study.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham - Main /ID# 260000', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '90212-1910', 'city': 'Beverly Hills', 'state': 'California', 'country': 'United States', 'facility': 'Bowman Medical Group /ID# 259989', 'geoPoint': {'lat': 34.07362, 'lon': -118.40036}}, {'zip': '95817-2310', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'UC Davis /ID# 259723', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '06416', 'city': 'Cromwell', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Montano Wellness LLC /ID# 259837', 'geoPoint': {'lat': 41.5951, 'lon': -72.64537}}, {'zip': '30318-3102', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Georgia Psychiatric Consultants & Advanced Discovery Research /ID# 259975', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '68144-2359', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Omaha Insomnia and Psychiatric Services /ID# 259961', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '44012-1004', 'city': 'Avon Lake', 'state': 'Ohio', 'country': 'United States', 'facility': 'Quest Therapeutics of Avon /ID# 259838', 'geoPoint': {'lat': 41.50532, 'lon': -82.0282}}, {'zip': '44130', 'city': 'Middleburg Heights', 'state': 'Ohio', 'country': 'United States', 'facility': 'North Star Medical Research LL /ID# 259730', 'geoPoint': {'lat': 41.36144, 'lon': -81.81291}}, {'zip': '73112', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Rivus Wellness And Research Institute /ID# 259966', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '97401-6008', 'city': 'Eugene', 'state': 'Oregon', 'country': 'United States', 'facility': 'Betts Psychiatric, PC /ID# 259737', 'geoPoint': {'lat': 44.05207, 'lon': -123.08675}}, {'zip': '75235-7709', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Ut Southwestern Medical Center /Parkland Health and Hospital System /Id# 260001', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': 'N7L 1C1', 'city': 'Chatham', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Chatham-Kent Clinical Trials /ID# 262414', 'geoPoint': {'lat': 42.41224, 'lon': -82.18494}}, {'zip': 'N2G 1G3', 'city': 'Kitchener', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Grand River Hospital /ID# 263962', 'geoPoint': {'lat': 43.42537, 'lon': -80.5112}}, {'zip': 'L5M 4N4', 'city': 'Mississauga', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Sunny Johnson Medical Research Associates /ID# 267713', 'geoPoint': {'lat': 43.5789, 'lon': -79.6583}}, {'zip': 'L3Y 2P9', 'city': 'Newmarket', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Southlake Regional Health Centre /ID# 264212', 'geoPoint': {'lat': 44.05011, 'lon': -79.46631}}, {'zip': 'M4W 2N4', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'START Clinic for Mood and Anxiety Disorders /ID# 262416', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'H1N 3M5', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Institut universitaire en santé mentale de Montréal /ID# 264665', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'J1G 2N5', 'city': 'Sherbrooke', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Clinique Woodward /ID# 264050', 'geoPoint': {'lat': 45.40008, 'lon': -71.89908}}, {'zip': 'H4H 1R2', 'city': 'Verdun', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Douglas Mental Health University Institute /ID# 262048', 'geoPoint': {'lat': 45.46005, 'lon': -73.57058}}], 'overallOfficials': [{'name': 'ABBVIE INC.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AbbVie'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AbbVie', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}