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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 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 377

Last updated 2016-08-22

Study results available
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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

Conditions

Interventions

DRUG

Lurasidone

Lurasidone 20-80 mg taken orally once daily

Sponsors & Collaborators

  • Sumitomo Pharma America, Inc.

    lead INDUSTRY

Principal Investigators

  • Lurasidone Medical Director, MD · Sumitomo Pharma America, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2015-07-31
Completion
2015-07-31

Countries

  • United States
  • Argentina
  • Bulgaria
  • Chile
  • Czechia
  • France
  • Hungary
  • Japan
  • Poland
  • Russia
  • Serbia
  • Slovakia

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01575561 on ClinicalTrials.gov