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Observing the effects of cariprazine on adults with Bipolar I Disorder

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

Observational AbbVie · NCT06256367

This study is testing how well cariprazine works for adults with Bipolar I Disorder who are starting treatment, especially those going through a major depressive episode.

Quick facts

Study typeObservational
Enrollment170 (estimated)
Ages18 Years and up
SexAll
SponsorAbbVie Industry-sponsored
Locations19 sites (Birmingham, Alabama and 18 other locations)
Trial IDNCT06256367 on ClinicalTrials.gov

What this trial studies

This observational study aims to assess the effectiveness and quality of life outcomes in adults diagnosed with Bipolar I Disorder who are initiating treatment with cariprazine. It will enroll approximately 170 participants from the United States and Canada, focusing on those experiencing a major depressive episode. The study will evaluate real-world outcomes of cariprazine treatment, providing insights into its impact on functioning and disease activity in a clinical setting.

Who should consider this trial

Good fit: Ideal candidates are adults with a confirmed diagnosis of Bipolar I Disorder who are beginning treatment with cariprazine and meet specific clinical criteria.

Not a fit: Patients with contraindications to cariprazine or those with conditions that may interfere with study participation may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance understanding of cariprazine's effectiveness in managing Bipolar I Disorder, potentially leading to improved treatment strategies.

How similar studies have performed: While this study is observational, previous studies on cariprazine have shown promising results in treating Bipolar I Disorder, indicating potential for success.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Birmingham, Alabama and 18 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Bipolar I DisorderCariprazineCReW BP-I
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.