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Aripiprazole in Adolescents With Schizophrenia

NCT ID: NCT00102063

Last Updated: 2012-08-10

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

302 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-07-31

Study Completion Date

2006-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Schizophrenia

Keywords

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Schizophrenia Aripiprazole

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Aripiprazole 10 mg/day Group

Dose was titrated to a target dose of 10 mg/day as follows: starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5; one dose reduction to 5 mg/day allowed after Day 25

Group Type ACTIVE_COMPARATOR

Aripiprazole tablet, 10 mg

Intervention Type DRUG

Aripiprazole tablet 10 mg po qd x 42 days

Aripiprazole 30 mg/day Group

Dose was titrated to a target dose of 30 mg/day as follows: starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, and 30 mg/day on Day 11; one dose reduction to 15 mg/day allowed after Day 25

Group Type ACTIVE_COMPARATOR

Aripiprazole tablet, 30 mg

Intervention Type DRUG

Aripiprazole tablet 30 mg po qd x 42 days

Placebo Group

Participants were given a single pill administered once daily

Group Type PLACEBO_COMPARATOR

Placebo tablet

Intervention Type DRUG

Placebo tablet po qd x 42 days

Interventions

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Aripiprazole tablet, 10 mg

Aripiprazole tablet 10 mg po qd x 42 days

Intervention Type DRUG

Aripiprazole tablet, 30 mg

Aripiprazole tablet 30 mg po qd x 42 days

Intervention Type DRUG

Placebo tablet

Placebo tablet po qd x 42 days

Intervention Type DRUG

Other Intervention Names

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OPC-14597 OPC-14597

Eligibility Criteria

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Inclusion Criteria

* Primary diagnosis of Schizophrenia 1

Exclusion Criteria

* Patients diagnosed with schizoaffective disorder, major depressive disorder, delirium, or bipolar disorder
Minimum Eligible Age

13 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Otsuka Pharmaceutical Development & Commercialization, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Margaretta Nyilas, M.D.

Role: STUDY_DIRECTOR

Otsuka Pharmaceutical Development & Commercialization, Inc.

Locations

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Local Institution

Birmingham, Alabama, United States

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Little Rock, Arkansas, United States

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Costa Mesa, California, United States

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Los Angeles, California, United States

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National City, California, United States

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Orange, California, United States

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Pasadena, California, United States

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Sacramento, California, United States

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San Diego, California, United States

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Temecula, California, United States

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Washington D.C., District of Columbia, United States

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Altamonte Springs, Florida, United States

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Fort Lauderdale, Florida, United States

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Gainesville, Florida, United States

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Hialeah, Florida, United States

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Jacksonville, Florida, United States

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Miami, Florida, United States

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North Miami, Florida, United States

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Orange City, Florida, United States

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Tampa, Florida, United States

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Newnan, Georgia, United States

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Smyrna, Georgia, United States

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Honolulu, Hawaii, United States

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Chicago, Illinois, United States

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Kansas City, Kansas, United States

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Lexington, Kentucky, United States

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Lake Charles, Louisiana, United States

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New Orleans, Louisiana, United States

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Medford, Massachusetts, United States

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Clinton Township, Michigan, United States

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Flowood, Mississippi, United States

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Kansas City, Missouri, United States

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Las Vegas, Nevada, United States

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Elmsford, New York, United States

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New York, New York, United States

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Olean, New York, United States

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Rochester, New York, United States

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Chapel Hill, North Carolina, United States

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Cleveland, Ohio, United States

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Lyndhurst, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Bala-Cynwyd, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Memphis, Tennessee, United States

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Bellaire, Texas, United States

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DeSoto, Texas, United States

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Houston, Texas, United States

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San Antonio, Texas, United States

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Salt Lake City, Utah, United States

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Richmond, Virginia, United States

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Kirkland, Washington, United States

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Spokane, Washington, United States

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Wauwatosa, Wisconsin, United States

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Rio Piedras, , Puerto Rico

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San Juan, , Puerto Rico

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Countries

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United States Puerto Rico

References

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Correll CU, Zhao J, Carson W, Marcus R, McQuade R, Forbes RA, Mankoski R. Early antipsychotic response to aripiprazole in adolescents with schizophrenia: predictive value for clinical outcomes. J Am Acad Child Adolesc Psychiatry. 2013 Jul;52(7):689-698.e3. doi: 10.1016/j.jaac.2013.04.018. Epub 2013 Jun 5.

Reference Type DERIVED
PMID: 23800482 (View on PubMed)

Robb AS, Carson WH, Nyilas M, Ali M, Forbes RA, Iwamoto T, Assuncao-Talbott S, Whitehead R, Pikalov A. Changes in positive and negative syndrome scale-derived hostility factor in adolescents with schizophrenia treated with aripiprazole: post hoc analysis of randomized clinical trial data. J Child Adolesc Psychopharmacol. 2010 Feb;20(1):33-8. doi: 10.1089/cap.2008.0163.

Reference Type DERIVED
PMID: 20166794 (View on PubMed)

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. doi: 10.1176/appi.ajp.2008.07061035. Epub 2008 Sep 2.

Reference Type DERIVED
PMID: 18765484 (View on PubMed)

Other Identifiers

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31-03-239

Identifier Type: -

Identifier Source: org_study_id