MedTrace Logo

Pediatric Schizophrenia Efficacy and Safety Study

NCT01911429 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 327

Last updated 2017-04-18

Study results available
· View outcomes & findings →

Summary

Efficacy and Safety study of Lurasidone in pediatric patients.

Conditions

Interventions

DRUG

Lurasidone 40 mg

Lurasidone 40 mg once daily

DRUG

Lurasidone 80 mg

Lurasidone 80 mg once daily

DRUG

Placebo 40 or 80 mg

Placebo 40 or 80 mg once daily

Sponsors & Collaborators

  • Sumitomo Pharma America, Inc.

    lead INDUSTRY

Principal Investigators

  • Lurasidone Medical Director · Sumitomo Pharma America, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
13 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-08-31
Primary Completion
2015-12-31
Completion
2015-12-31

Countries

  • United States
  • Belgium
  • Bulgaria
  • Colombia
  • France
  • Hungary
  • Malaysia
  • Mexico
  • Philippines
  • Poland
  • Puerto Rico
  • Romania
  • Russia
  • South Korea
  • Spain
  • Ukraine
  • United Kingdom

Study Locations

More Related Trials

Entities

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 NCT01911429 on ClinicalTrials.gov