Observational Study of Oral Cariprazine Capsules to Assess Change in Disease Activity in Adult Participants With Bipolar I Disorder

Completed

Conditions studied: Bipolar I Disorder

In brief

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. 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.

Key facts

Study ID: NCT06256367
Run by: AbbVie
People needed: 120
Starts: 2024-04-18
Expected to finish: 2026-01-23
Last updated by the study team: 2026-02-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Have a physician-confirmed diagnosis of BP-I, with or without comorbidities.
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.

You may not qualify if…

Have a medical or psychiatric condition, or planned surgical procedure, which will interfere with study participation, as judged by the investigator.
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.

Where it is running

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

Full record on ClinicalTrials.gov

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