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

AbbVie

Status: Active, not recruiting

Conditions: Bipolar I Disorder

Study type: Observational

Funder types: Industry

Identifiers

NCT06256367

P24-477

Details and patient eligibility

About

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.

Enrollment: 170 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

170 participants in 1 patient group

Cariprazine

Description:

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.