Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
AbbVie
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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.
Clareo Health | Observational Study of Oral Cariprazine Capsules to Assess Change in Disease Activity in Adult Participants With Bipolar I Disorder