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

NCT06256367 | Completed

• 1 other identifier: P24-477
• Study Type: observational
• Target: 120
• Locations: 2 countries
• Sites: 19

Brief 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

Bipolar I Disorder

Keywords

Bipolar I Disorder; Cariprazine; CReW BP-I

Outcome Measures

Primary Outcomes (1)

• Change From Baseline on Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score

  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.

  Up to Week 12

Secondary Outcomes (1)

• Change From Baseline on Functioning Assessment Short Test (FAST) Total Score

  Up to Week 12

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with a bipolar I disorder diagnosis experiencing a major depressive episode (with or without mixed features) requiring treatment and being prescribed cariprazine by their physician; irrespective of study participation.

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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (19)

University of Alabama at Birmingham - Main /ID# 260000

Birmingham, Alabama, 35233, United States

Location

Bowman Medical Group /ID# 259989

Beverly Hills, California, 90212-1910, United States

Location

UC Davis /ID# 259723

Sacramento, California, 95817-2310, United States

Location

Montano Wellness LLC /ID# 259837

Cromwell, Connecticut, 06416, United States

Location

Georgia Psychiatric Consultants & Advanced Discovery Research /ID# 259975

Atlanta, Georgia, 30318-3102, United States

Location

Omaha Insomnia and Psychiatric Services /ID# 259961

Omaha, Nebraska, 68144-2359, United States

Location

Quest Therapeutics of Avon /ID# 259838

Avon Lake, Ohio, 44012-1004, United States

Location

North Star Medical Research LL /ID# 259730

Middleburg Heights, Ohio, 44130, United States

Location

Rivus Wellness And Research Institute /ID# 259966

Oklahoma City, Oklahoma, 73112, United States

Location

Betts Psychiatric, PC /ID# 259737

Eugene, Oregon, 97401-6008, United States

Location

Ut Southwestern Medical Center /Parkland Health and Hospital System /Id# 260001

Dallas, Texas, 75235-7709, United States

Location

Chatham-Kent Clinical Trials /ID# 262414

Chatham, Ontario, N7L 1C1, Canada

Location

Grand River Hospital /ID# 263962

Kitchener, Ontario, N2G 1G3, Canada

Location

Sunny Johnson Medical Research Associates /ID# 267713

Mississauga, Ontario, L5M 4N4, Canada

Location

Southlake Regional Health Centre /ID# 264212

Newmarket, Ontario, L3Y 2P9, Canada

Location

START Clinic for Mood and Anxiety Disorders /ID# 262416

Toronto, Ontario, M4W 2N4, Canada

Location

Institut universitaire en santé mentale de Montréal /ID# 264665

Montreal, Quebec, H1N 3M5, Canada

Location

Clinique Woodward /ID# 264050

Sherbrooke, Quebec, J1G 2N5, Canada

Location

Douglas Mental Health University Institute /ID# 262048

Verdun, Quebec, H4H 1R2, Canada

Location

Related Links

• Related Info

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2024
• First Posted: February 13, 2024
• Study Start: April 18, 2024
• Primary Completion: January 23, 2026
• Study Completion: January 23, 2026
• Last Updated: February 24, 2026

Record last verified: 2026-02

Locations

CA (8); US (11)