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Lurasidone - A 24-week Extension Study of Patients With Bipolar I Depression

NCT00868959 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 817

Last updated 2016-04-14

Study results available
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Summary

This clinical study is designed to test the hypothesis that lurasidone is effective, tolerable, and safe for the treatment of patients with bipolar I depression

Conditions

Interventions

DRUG

lurasidone

Lurasidone 20-120 mg/d Flexibly Dosed - 24 weeks

Sponsors & Collaborators

  • Sumitomo Pharma America, Inc.

    lead INDUSTRY

Principal Investigators

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

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-04-30
Primary Completion
2013-02-28
Completion
2013-02-28

Countries

  • United States
  • Canada
  • Colombia
  • Czechia
  • France
  • India
  • Japan
  • Lithuania
  • Peru
  • Poland
  • Romania
  • Russia
  • Slovakia
  • South Africa
  • Ukraine

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 NCT00868959 on ClinicalTrials.gov