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NCT06256367 · ClinicalTrials.gov registry record
Observational Study of Oral Cariprazine Capsules to Assess Change in Disease Activity in Adult Participants With Bipolar I Disorder
A clinical trial of Bipolar I Disorder, sponsored by AbbVie.
- Completed
- Registry status
- 120
- Enrollment target
- 19
- Study locations
NCT06256367: Completed study of Bipolar I Disorder, sponsored by AbbVie.
NCT06256367 is a study of Bipolar I Disorder that has completed, run by AbbVie. The registered enrollment target is 120 participants, below the 325-participant average among 26 other Bipolar I Disorder trials with a reported enrollment target (63% lower). The trial reports 19 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06256367, a study of Bipolar I Disorder, has completed, sponsored by AbbVie.
- COMPLETED
- Registry status
- 120 participants
- Enrollment target
- 19
- Study locations
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.
Primary Outcome
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.
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 |
What the finished NCT06256367 record still lists
NCT06256367 is an observational study that tracks outcomes without assigning an intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, below the 325-participant average among 26 other Bipolar I Disorder trials with a reported enrollment target (63% lower).
The record links to 1 condition, with Bipolar I Disorder appearing as the primary indexed condition, and to 0 interventions.
NCT06256367 lists 19 locations in 11 states (Ontario, Quebec, California).
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.
Who is sponsoring clinical trial NCT06256367?
This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Where NCT06256367's enrollment target sits among peer trials
120 15th of 26 higher than 12 of 26 other Bipolar I Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Bipolar I Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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