Observational Study of Oral Cariprazine Capsules to Assess Change in Disease Activity in Adult Participants With Bipolar I Disorder
Public ClinicalTrials.gov record NCT06256367. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Cariprazine Real-world Use in Bipolar I Disorder: Effectiveness, Functioning, Quality of Life, and Tolerability
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT06256367
- Recruitment status
- Completed
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 120 participants
Conditions and interventions
Conditions
Interventions
Not listed
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 17, 2024
- Primary completion
- Jan 22, 2026
- Completion
- Jan 22, 2026
- Last update posted
- Feb 23, 2026
2024 – 2026
United States locations
- U.S. sites
- 11
- U.S. states
- 9
- U.S. cities
- 11
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham - Main /ID# 260000 | Birmingham | Alabama | 35233 | — |
| Bowman Medical Group /ID# 259989 | Beverly Hills | California | 90212-1910 | — |
| UC Davis /ID# 259723 | Sacramento | California | 95817-2310 | — |
| Montano Wellness LLC /ID# 259837 | Cromwell | Connecticut | 06416 | — |
| Georgia Psychiatric Consultants & Advanced Discovery Research /ID# 259975 | Atlanta | Georgia | 30318-3102 | — |
| Omaha Insomnia and Psychiatric Services /ID# 259961 | Omaha | Nebraska | 68144-2359 | — |
| Quest Therapeutics of Avon /ID# 259838 | Avon Lake | Ohio | 44012-1004 | — |
| North Star Medical Research LL /ID# 259730 | Middleburg Heights | Ohio | 44130 | — |
| Rivus Wellness And Research Institute /ID# 259966 | Oklahoma City | Oklahoma | 73112 | — |
| Betts Psychiatric, PC /ID# 259737 | Eugene | Oregon | 97401-6008 | — |
| Ut Southwestern Medical Center /Parkland Health and Hospital System /Id# 260001 | Dallas | Texas | 75235-7709 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 8 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06256367, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 23, 2026 · Synced Sep 3, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06256367 live on ClinicalTrials.gov.