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Aripiprazole in Adolescents With Schizophrenia

NCT00102063 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 302

Last updated 2012-08-10

Study results available
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Summary

The purpose of this trial is to test the safety and efficacy of aripiprazole in adolescent patients with schizophrenia for a period of at least 6 weeks.

Conditions

Interventions

DRUG

Aripiprazole tablet, 10 mg

Aripiprazole tablet 10 mg po qd x 42 days

DRUG

Aripiprazole tablet, 30 mg

Aripiprazole tablet 30 mg po qd x 42 days

DRUG

Placebo tablet

Placebo tablet po qd x 42 days

Sponsors & Collaborators

  • Otsuka Pharmaceutical Development & Commercialization, Inc.

    lead INDUSTRY

Principal Investigators

  • Margaretta Nyilas, M.D. · Otsuka Pharmaceutical Development & Commercialization, 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
2004-07-31
Primary Completion
2006-08-31
Completion
2006-08-31

Countries

  • United States
  • Puerto Rico

Study Locations

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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 NCT00102063 on ClinicalTrials.gov