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Lurasidone HCI - A 6-week Phase 3 Study of Patients With Bipolar I Depression

NCT01284517 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 356

Last updated 2013-11-26

Study results available
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Summary

Lurasidone HCI is a compound that is a candidate for the treatment of bipolar I depression. This clinical study is designed to test the hypothesis that Lurasidone in combination with either Lithium or Divalproex is effective among patients with bipolar I depression.

Conditions

Interventions

DRUG

Lurasidone

Tablets 20-120 mg, PM dosing,daily for 6 weeks

DRUG

Placebo

Equivalent to Lurasidone dosing

Sponsors & Collaborators

  • Sumitomo Pharma America, Inc.

    lead INDUSTRY

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2010-11-30
Primary Completion
2012-08-31
Completion
2012-08-31

Countries

  • United States
  • Canada
  • Colombia
  • Czechia
  • India
  • Japan
  • Lithuania
  • Peru
  • Slovakia
  • 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 NCT01284517 on ClinicalTrials.gov