Efficacy and safety of cariprazine in bipolar I depression: A double-blind, placebo-controlled phase 3 study.

ABSTRACT:

Objective

To assess the efficacy, safety, and tolerability of cariprazine in the treatment of the depressed phase of bipolar I disorder in adults (NCT02670538).

Methods

In this phase 3 double-blind placebo-controlled study, adult patients with bipolar I disorder according to the Diagnostic and Statistical Manual - 5th Edition criteria and a current depressive episode were randomized to placebo (n = 167), cariprazine 1.5 mg/day (n = 168) or cariprazine 3.0 mg/day (n = 158). Efficacy parameters were changes in the Montgomery-Åsberg Depression Rating Scale (MADRS) total scores (primary) and Clinical Global Impressions - Severity (CGI-S) scores (secondary) from baseline to Week 6 compared to placebo. A mixed-model for repeated measures was used to estimate the least-squares mean

SUBMITTER: Earley WR 

PROVIDER: S-EPMC7318333 | biostudies-literature | 2020 Jun

REPOSITORIES: biostudies-literature