Phase 3
Completed N=896
A Cariprazine Study in the Prevention of Relapse in Bipolar I Disorder Patients Whose Current Episode is Manic or Depressive, With or Without Mixed Features
Source: ClinicalTrials.gov NCT03573297 ↗Enrolled (actual)
896
Serious AEs
2.6%
Results posted
Sep 2023
Primary outcomePrimary: Time to First Relapse of Any Mood Episode During the Double-Blind Treatment Period — NA; NA; NA; NA days — p=0.5745
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
1) To evaluate the efficacy and safety of cariprazine at a target dose of 3.0 mg/day compared with placebo in prevention of relapse in patients with bipolar I disorder whose current episode (i.e. index episode) is manic or depressive, with or without mixed features; 2) To evaluate the efficacy and safety of cariprazine at a target dose of 1.5 mg/day compared with placebo in prevention of relapse in patients with bipolar I disorder whose current episode (i.e. index episode) is manic or depressive, with or without mixed features who were initially stabilized on a target dose of 3.0 mg/day
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to First Relapse of Any Mood Episode During the Double-Blind Treatment Period |
NA; NA; NA; NA; NA; NA | 0.5745 |
Eligibility Criteria
Inclusion Criteria
- Currently meet the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for bipolar I disorder, and at least one of the following two criteria:
- Current episode manic, with or without mixed features, having a total Young Mania Rating Scale (YMRS) total score ≥ 20 and a score of at least 4 on 2 YMRS items (irritability, speech, content, or disruptive/aggressive behavior);
- OR current episode depressive, with or without mixed features, having a Montgomery-Asberg Depression Rating Scale (MADRS) total score ≥ 23 and a score of at least 3 on 2 MADRS items (apparent sadness, reported sadness, inner tension or inability to feel).
Exclusion Criteria
- Four or more episodes of a mood disturbance within the 12 months before Visit 1;
- Diagnosis of another psychiatric disorder other than bipolar disorder with the exception of specific phobias.
Data sourced from ClinicalTrials.gov (NCT03573297). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.