drugset / Trial / NCT01575561

This is an Open-label, Multi-center, Extension Study Designed to Evaluate the Longer Term Safety, Tolerability and Effectiveness of Lurasidone, Flexibly Dosed, Adjunctive to Lithium or Divalproex for the Treatment of Subjects With Bipolar I Disorder Who Have Participated in Study D1050296

NCT01575561

Phase 3 Completed 377 enrolled Sumitomo Pharma America, Inc.
NaSingle-groupOpen-labelTreatment

Summary

This is an open-label, multi-center,12 week extension study designed to evaluate the longer term safety, tolerability and effectiveness of lurasidone, flexibly dosed, adjunctive to lithium or divalproex for the treatment of subjects with bipolar I disorder, who have either completed the core study D1050296 or experienced a protocol defined recurrence of a mood event in the double-blind phase of the core study D1050296

Timeline

Start
2012-06
Primary completion
2015-07
Completion
2015-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Lurasidone Small molecule 20 mg Oral
Subject Lurasidone Small molecule 40 mg Oral
Subject Lurasidone Small molecule 60 mg Oral
Subject Lurasidone Small molecule 80 mg Oral

Indications