Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:54 AM
Ignite Modification Date:
2025-12-25 @ 12:54 AM
NCT ID:
NCT06256367
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06256367
Study Brief:
Protocol Section:
NCT06256367