Double-blind, placebo-controlled study of lurasidone monotherapy for the treatment of bipolar I depression.

ABSTRACT:

Aim

Previous studies conducted primarily in the USA and Europe have demonstrated the efficacy and safety of lurasidone 20-120 mg/day for the treatment of bipolar I depression. The aim of the current study was to evaluate the efficacy and safety of lurasidone monotherapy for the treatment of bipolar I depression among patients from diverse ethnic backgrounds, including those from Japan.

Methods

Patients were randomly assigned to double-blind treatment for 6 weeks with lurasidone, 20-60 mg/day (n = 184) or 80-120 mg/day (n = 169), or placebo (n = 172). The primary end-point was change from baseline to Week 6 on the Montgomery-Åsberg Depression Rating Scale (MADRS).

Results

Lurasidone treatment significantly reduced mean MADRS total scores from baseline to Week 6 for the

SUBMITTER: Kato T 

PROVIDER: S-EPMC7756283 | biostudies-literature | 2020 Dec

REPOSITORIES: biostudies-literature