drugset / Trial / 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

NCT03573297

Phase 3 Completed 901 enrolled AbbVie
RandomizedParallel-groupDouble-blindTreatment

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

Timeline

Start
2018-06-15
Primary completion
2022-09-05
Completion
2022-09-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Cariprazine Small molecule 1.5 mg Oral
Subject Cariprazine Small molecule 3 mg Oral