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
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |