Aripiprazole in Adolescents With Schizophrenia

This study has been completed.

First Received: January 19, 2005 Last Updated: December 21, 2007 History of Changes

Sponsored by:	Otsuka Pharmaceutical Development & Commercialization, Inc.
Information provided by:	Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier:	NCT00102063

Purpose

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.

Condition	Intervention	Phase
Schizophrenia	Drug: Aripiprazole Drug: Aripiprazole tablet Drug: Placebo tablet po for 42 days	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Aripiprazole in Adolescents With Schizophrenia

Resource links provided by NLM:

MedlinePlus related topics: Schizophrenia

Drug Information available for: Aripiprazole

U.S. FDA Resources

Further study details as provided by Otsuka Pharmaceutical Development & Commercialization, Inc.:

Primary Outcome Measures:

Mean change from Baseline to Endpoint (Day 42) in the Positive and Negative Syndrome Scale (PANSS) Total Score [ Time Frame: 42 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Mean changes(baseline to endpoint)in CGAS,CGI-severity,CGI-improvement and PANSS(pos/neg).Hospitalizations collected,P-QLES-Q administered. [ Time Frame: 42 Days ] [ Designated as safety issue: Yes ]

Enrollment:	302
Study Start Date:	July 2004
Study Completion Date:	August 2006
Primary Completion Date:	August 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Aripiprazole 10 mg tablet	Drug: Aripiprazole Aripiprazole 10 mg tablet po qd x 42 days
2: Active Comparator Aripiprazole 30 mg tablet	Drug: Aripiprazole tablet Aripiprazole tablet 30 mg po qd x 42 days
3: Placebo Comparator Placebo po qd x 42 days	Drug: Placebo tablet po for 42 days Placebo

Eligibility

Ages Eligible for Study:	13 Years to 17 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Primary diagnosis of Schizophrenia 1

Exclusion Criteria:

Patients diagnosed with schizoaffective disorder, major depressive disorder, delirium, or bipolar disorder

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00102063

Show 55 Study Locations

Sponsors and Collaborators

Otsuka Pharmaceutical Development & Commercialization, Inc.

Investigators

Study Director:

Margaretta Nyillas, MD

Otsuka Pharmaceutical Development & Commercialization, Inc.

More Information

No publications provided by Otsuka Pharmaceutical Development & Commercialization, Inc.

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Findling RL, Robb A, Nyilas M, Forbes RA, Jin N, Ivanova S, Marcus R, McQuade RD, Iwamoto T, Carson WH. A multiple-center, randomized, double-blind, placebo-controlled study of oral aripiprazole for treatment of adolescents with schizophrenia. Am J Psychiatry. 2008 Nov;165(11):1432-41. Epub 2008 Sep 2.

Responsible Party:	Children's National Medical Center ( Adelaide S. Robb, MD )
Study ID Numbers:	31-03-239, WHO
Study First Received:	January 19, 2005
Last Updated:	December 21, 2007
ClinicalTrials.gov Identifier:	NCT00102063 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Otsuka Pharmaceutical Development & Commercialization, Inc.:

Schizophrenia
Aripiprazole

Study placed in the following topic categories:

Schizophrenia
Tranquilizing Agents
Mental Disorders
Psychotropic Drugs
Central Nervous System Depressants

Psychotic Disorders
Aripiprazole
Antipsychotic Agents
Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:

Schizophrenia
Tranquilizing Agents
Mental Disorders
Therapeutic Uses
Physiological Effects of Drugs
Psychotropic Drugs

Central Nervous System Depressants
Aripiprazole
Antipsychotic Agents
Central Nervous System Agents
Pharmacologic Actions
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on September 11, 2009