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

Launched by ABBVIE · Feb 5, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a medication called cariprazine (brand name Vraylar) in adults who have been diagnosed with Bipolar I disorder (BP-I) and are currently experiencing a major depressive episode. The goal is to see how well cariprazine works in improving mood, daily functioning, and overall quality of life for these patients in a real-world setting. The study will include about 170 adult participants from the United States and Canada who are starting treatment with cariprazine as prescribed by their doctor.

To be eligible for the trial, participants must have a confirmed diagnosis of BP-I and meet certain criteria, such as having a specific level of depression and functioning at the start of the study. They should not have used cariprazine during their current depressive episode. During the trial, participants will continue to receive cariprazine as prescribed, and researchers will collect information about their progress over a period of up to 24 weeks during regular doctor visits. It’s important to note that the decision to start cariprazine treatment should be made separately from the decision to participate in the study.

Gender

ALL

Eligibility criteria

• 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.