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PEARL Schizophrenia Maintenance

NCT01435928 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 676

Last updated 2016-04-08

Study results available
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Summary

Lurasidone HCI is a compound that is FDA-approved for the treatment of schizophrenia. This clinical study is designed to test the hypothesis that Lurasidone is effective in the long term maintenance treatment of schizophrenia.

Conditions

Interventions

DRUG

Lurasidone

Lurasidone 40 and 80 mg, once daily in the evening with a meal or 30 minutes after eating

DRUG

Matching Placebo

Matching placebo once daily in the evening with a meal or 30 minutes after eating

Sponsors & Collaborators

  • Sumitomo Pharma America, Inc.

    lead INDUSTRY

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2013-08-31
Completion
2013-08-31

Countries

  • United States
  • France
  • Italy
  • Russia
  • Serbia
  • Slovakia
  • South Africa

Study Locations

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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 NCT01435928 on ClinicalTrials.gov