Phase 3 N=896 Randomized Double-blind Treatment

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

Bipolar I Disorder · Mania · Depression

Bottom Line

View on ClinicalTrials.gov: NCT03573297 ↗

Enrolled (actual)

896

Serious AEs

2.6%

Results posted

Sep 2023

Primary outcome: Primary: Time to First Relapse of Any Mood Episode During the Double-Blind Treatment Period — NA; NA; NA; NA days — p=0.5745

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Cariprazine (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: AbbVie
Primary completion: Sep 2022

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

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

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.

View full record on ClinicalTrials.gov →

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.