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

Bipolar I Disorder Clinical Trial

— CReW BP-I  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06256367
• Other study ID #: P24-477
• Status: Not yet recruiting
• Start date: February 7, 2024
• Est. completion date: June 27, 2025

Study information

• Verified date: February 2024
• Source: AbbVie
• Contact: Julie Charbonneau
• Phone: 5148327197
• Email: julie.charbonneau[@]abbvie.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 170
• Est. completion date: June 27, 2025
• Est. primary completion date: June 27, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bipolar I Disorder

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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

External Links

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