Observational Study of Oral Cariprazine Capsules to Assess Change in Disease Activity in Adult Participants With Bipolar I Disorder (CReW BP-I)

Cariprazine Real-world Use in Bipolar I Disorder: Effectiveness, Functioning, Quality of Life, and Tolerability

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 Overview

• Status: Completed
• Conditions: Bipolar I Disorder

• Study Type: Observational
• Enrollment (Actual): 120

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Chatham, Ontario, Canada, N7L 1C1
      • Chatham-Kent Clinical Trials /ID# 262414
    • Kitchener, Ontario, Canada, N2G 1G3
      • Grand River Hospital /ID# 263962
    • Mississauga, Ontario, Canada, L5M 4N4
      • Sunny Johnson Medical Research Associates /ID# 267713
    • Newmarket, Ontario, Canada, L3Y 2P9
      • Southlake Regional Health Centre /ID# 264212
    • Toronto, Ontario, Canada, M4W 2N4
      • START Clinic for Mood and Anxiety Disorders /ID# 262416
  • Quebec
    • Montreal, Quebec, Canada, H1N 3M5
      • Institut universitaire en santé mentale de Montréal /ID# 264665
    • Sherbrooke, Quebec, Canada, J1G 2N5
      • Clinique Woodward /ID# 264050
    • Verdun, Quebec, Canada, H4H 1R2
      • Douglas Mental Health University Institute /ID# 262048
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • University of Alabama at Birmingham - Main /ID# 260000
  • California
    • Beverly Hills, California, United States, 90212-1910
      • Bowman Medical Group /ID# 259989
    • Sacramento, California, United States, 95817-2310
      • UC Davis /ID# 259723
  • Connecticut
    • Cromwell, Connecticut, United States, 06416
      • Montano Wellness LLC /ID# 259837
  • Georgia
    • Atlanta, Georgia, United States, 30318-3102
      • Georgia Psychiatric Consultants & Advanced Discovery Research /ID# 259975
  • Nebraska
    • Omaha, Nebraska, United States, 68144-2359
      • Omaha Insomnia and Psychiatric Services /ID# 259961
  • Ohio
    • Avon Lake, Ohio, United States, 44012-1004
      • Quest Therapeutics of Avon /ID# 259838
    • Middleburg Heights, Ohio, United States, 44130
      • North Star Medical Research LL /ID# 259730
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73112
      • Rivus Wellness And Research Institute /ID# 259966
  • Oregon
    • Eugene, Oregon, United States, 97401-6008
      • Betts Psychiatric, PC /ID# 259737
  • Texas
    • Dallas, Texas, United States, 75235-7709
      • Ut Southwestern Medical Center /Parkland Health and Hospital System /Id# 260001

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline on Functioning Assessment Short Test (FAST) Total Score	The FAST is comprised of 24 items and assesses disability or impairment in 6 domains: autonomy, occupational functioning, financial issues, interpersonal relationships, cognitive functioning, and leisure time. FAST is administered by the investigator as an interview. Items are rated using a 4-point scale, from 0 (no difficulty) to 3 (severe difficulty) then summed for a total score. Higher scores indicate more severe impairment.	Up to Week 12

Collaborators and Investigators

• Sponsor: AbbVie
• Investigators: Study Director: ABBVIE INC., AbbVie

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): April 18, 2024
• Primary Completion (Actual): January 23, 2026
• Study Completion (Actual): January 23, 2026

Study Registration Dates

• First Submitted: February 5, 2024
• First Submitted That Met QC Criteria: February 5, 2024
• First Posted (Actual): February 13, 2024

Study Record Updates

• Last Update Posted (Actual): February 24, 2026
• Last Update Submitted That Met QC Criteria: February 23, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Bipolar I Disorder; Cariprazine; CReW BP-I
• Other Study ID Numbers: P24-477

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No