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Observational Study of Oral Cariprazine Capsules to Assess Change in Disease Activity in Adult Participants With Bipolar I Disorder
NCT06256367 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Study Locations (19)
Ontario
- Chatham-Kent Clinical Trials /ID# 262414 — Chatham
- Grand River Hospital /ID# 263962 — Kitchener
- Sunny Johnson Medical Research Associates /ID# 267713 — Mississauga
- Southlake Regional Health Centre /ID# 264212 — Newmarket
- START Clinic for Mood and Anxiety Disorders /ID# 262416 — Toronto
Quebec
- Institut universitaire en santé mentale de Montréal /ID# 264665 — Montreal
- Clinique Woodward /ID# 264050 — Sherbrooke
- Douglas Mental Health University Institute /ID# 262048 — Verdun
California
- Bowman Medical Group /ID# 259989 — Beverly Hills
- UC Davis /ID# 259723 — Sacramento
Ohio
- Quest Therapeutics of Avon /ID# 259838 — Avon Lake
- North Star Medical Research LL /ID# 259730 — Middleburg Heights
Alabama
- University of Alabama at Birmingham - Main /ID# 260000 — Birmingham
Connecticut
- Montano Wellness LLC /ID# 259837 — Cromwell
Georgia
- Georgia Psychiatric Consultants & Advanced Discovery Research /ID# 259975 — Atlanta
Nebraska
- Omaha Insomnia and Psychiatric Services /ID# 259961 — Omaha
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2024-04-18 |
| Est. Completion | 2026-01-23 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06256367
The ClinicalTrials.gov registry entry for NCT06256367 describes a study currently listed as completed. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AbbVie, which has 603 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Bipolar I Disorder appearing as the primary indexed condition, and to 0 interventions. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06256367 reports 19 study locations spanning 11 distinct geographic areas — top geographies include Ontario, Quebec, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06256367 about?
NCT06256367 is a clinical study titled "Observational Study of Oral Cariprazine Capsules to Assess Change in Disease Activity in Adult Participants With Bipolar I Disorder". 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 ...
What is the current status of trial NCT06256367?
This trial is currently completed. The enrollment target is 120 participants. The study started on 2024-04-18. Estimated completion is 2026-01-23.
What conditions does trial NCT06256367 study?
This clinical trial studies the following conditions: Bipolar I Disorder. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
Who is sponsoring clinical trial NCT06256367?
This trial is sponsored by AbbVie, which has 603 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06256367 being conducted?
This trial has 19 study locations across Alabama, California, Connecticut, Georgia, Nebraska. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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