drugset / Trial / NCT01358357

Bipolar Maintenance Study of Lurasidone Adjunctive to Lithium or Divalproex

NCT01358357

Phase 3 Completed 965 enrolled Sumitomo Pharma America, Inc.
RandomizedParallel-groupTriple-blindTreatment

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

Drugs

EvaluationDrugModalityDoseRoute
Subject Lurasidone Small molecule

Indications