Observational Study of Oral Cariprazine Capsules to Assess Change in Disease Activity in Adult Participants With Bipolar I Disorder
NCT ID: NCT06256367
Last Updated: 2025-09-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
170 participants
OBSERVATIONAL
2024-04-18
2026-02-28
Brief Summary
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Cariprazine (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.
Participants 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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Cariprazine
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.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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.
* Have a Montgomery-Åsberg Depression Rating Scale (MADRS) score \>= 20 at baseline.
* Have a Functioning Assessment Short Test (FAST) score \>= 21 at baseline.
* Naïve to cariprazine in the current major depressive episode.
Exclusion Criteria
* Have a known contraindication to cariprazine including any of the following:
* Hypersensitivity to cariprazine or any ingredient in the formulation
* For all sites, concomitant use of strong cytochrome P450 (CYP) 3A4 inhibitors and inducers
* For Canadian sites, as per country label, concomitant use of moderate CYP 3A4 inhibitors and inducers
* Current major depressive episode duration \> 12 months.
18 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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ABBVIE INC.
Role: STUDY_DIRECTOR
AbbVie
Locations
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University of Alabama at Birmingham - Main /ID# 260000
Birmingham, Alabama, United States
Bowman Medical Group /ID# 259989
Beverly Hills, California, United States
UC Davis /ID# 259723
Sacramento, California, United States
Montano Wellness LLC /ID# 259837
Cromwell, Connecticut, United States
Georgia Psychiatric Consultants & Advanced Discovery Research /ID# 259975
Atlanta, Georgia, United States
Omaha Insomnia and Psychiatric Services /ID# 259961
Omaha, Nebraska, United States
Quest Therapeutics of Avon /ID# 259838
Avon Lake, Ohio, United States
North Star Medical Research LL /ID# 259730
Middleburg Heights, Ohio, United States
Rivus Wellness And Research Institute /ID# 259966
Oklahoma City, Oklahoma, United States
Betts Psychiatric, PC /ID# 259737
Eugene, Oregon, United States
Ut Southwestern Medical Center /Parkland Health and Hospital System /Id# 260001
Dallas, Texas, United States
Chatham-Kent Clinical Trials /ID# 262414
Chatham, Ontario, Canada
Grand River Hospital /ID# 263962
Kitchener, Ontario, Canada
Sunny Johnson Medical Research Associates /ID# 267713
Mississauga, Ontario, Canada
Southlake Regional Health Centre /ID# 264212
Newmarket, Ontario, Canada
START Clinic for Mood and Anxiety Disorders /ID# 262416
Toronto, Ontario, Canada
Institut universitaire en santé mentale de Montréal /ID# 264665
Montreal, Quebec, Canada
Clinique Woodward /ID# 264050
Sherbrooke, Quebec, Canada
Douglas Mental Health University Institute /ID# 262048
Verdun, Quebec, Canada
Countries
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Related Links
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Other Identifiers
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P24-477
Identifier Type: -
Identifier Source: org_study_id
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