NCT03573297

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

A Double-blind, Placebo-controlled, Randomized Withdrawal, Multicenter Clinical Trial Evaluating the Efficacy, Safety and Tolerability of Cariprazine in a Dose-reduction Paradigm in the Prevention of Relapse in Bipolar I Disorder Patients Whose Current Episode is Manic or Depressive, With or Without Mixed Features

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 901 (actual)
• Sponsor: AbbVie · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Conditions

• Bipolar I Disorder
• Mania
• Depression

Interventions

Type	Name	Description
DRUG	Cariprazine	Cariprazine capsules, oral administration, once daily
DRUG	Placebo	Matching placebo capsules, oral administration, once daily

Timeline

• Start date: 2018-06-15
• Primary completion: 2022-09-05
• Completion: 2022-09-05
• First posted: 2018-06-29
• Last updated: 2023-09-28
• Results posted: 2023-09-28

Locations

108 sites across 11 countries: United States, Bulgaria, Malaysia, Poland, Puerto Rico, Russia, Serbia, South Korea, Taiwan, Thailand, Ukraine

Regulatory

• FDA-regulated drug study