Bipolar Maintenance Study of Lurasidone Adjunctive to Lithium or Divalproex

Summary

This is a multi-center, randomized, placebo-controlled, flexible-dose, parallel-group study designed to evaluate the efficacy and safety of lurasidone (in combination with lithium or divalproex) for the maintenance treatment of bipolar I disorder in subjects with or without rapid cycling and /or psychotic features.

Timeline

Start

2011-06

Primary completion

2015-04

Completion

2015-04

Outcome

Missed primary endpoint

registry p <0.078; Hazard Ratio (HR) 0.71 (95% CI 0.49 to 1.04) NCT01358357 ↗

Drugs

Indications