Aripiprazole in Adolescents With Schizophrenia

NCT00102063 | Completed Phase 3 Results

• 1 other identifier: 31-03-239
• Study Type: interventional
• Target: 302
• Locations: 2 countries
• Sites: 55

Brief 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

Schizophrenia

Keywords

Schizophrenia; Aripiprazole

Outcome Measures

Primary Outcomes (1)

• Change in Positive and Negative Syndrome Scale (PANSS) Total Score

  Change from baseline to last observed post-baseline value in PANSS total score, using the last observation carried forward. This scale consists of symptom constructs (7 positive, 7 negative, 16 general psychopathology), each to be rated on a 7-point scale of severity with 1 being absent to 7 being extreme. Minimum score is 30 which is best outcome; maximum score is 210 for worse outcome.

  Baseline and Day 42

Secondary Outcomes (5)

• Change in Positive and Negative Syndrome Scale (PANSS) Positive Subscale Score

  Baseline and Day 42

• Change in Positive and Negative Syndrome Scale (PANSS) Negative Subscale Score

  Baseline and Day 42

• Change in Clinical Global Impression (CGI) Severity Score

  Baseline and Day 42

• Clinical Global Impression (CGI) Improvement Score

  Baseline and Day 42

• Change in Children's Global Assessment Scale (CGAS) Score

  Baseline and Day 42

Other Outcomes (2)

• Change in Pediatric Quality of Life Enjoyment and Satisfaction (PQLES) Questionnaire Total Score

  Baseline and Day 42

• Patients Achieving Remission

  Baseline and Day 42

Study Arms (3)

Aripiprazole 10 mg/day Group

ACTIVE COMPARATOR

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

Drug: Aripiprazole tablet, 10 mg

Aripiprazole 30 mg/day Group

ACTIVE COMPARATOR

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

Drug: Aripiprazole tablet, 30 mg

Placebo Group

PLACEBO COMPARATOR

Participants were given a single pill administered once daily

Drug: Placebo tablet

Interventions

Aripiprazole tablet, 10 mg DRUG

Aripiprazole tablet 10 mg po qd x 42 days

Also known as: OPC-14597

Aripiprazole 10 mg/day Group

Aripiprazole tablet, 30 mg DRUG

Aripiprazole tablet 30 mg po qd x 42 days

Also known as: OPC-14597

Aripiprazole 30 mg/day Group

Placebo tablet DRUG

Placebo tablet po qd x 42 days

Placebo Group

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Primary diagnosis of Schizophrenia 1

You may not qualify if:

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

Sponsors & Collaborators

• Otsuka Pharmaceutical Development & Commercialization, Inc.: lead

Study Sites (55)

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

Location

Related Publications (3)

• 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.

  PMID: 23800482 DERIVED

• 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.

  PMID: 20166794 DERIVED

• 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.

  PMID: 18765484 DERIVED

MeSH Terms

Conditions

Schizophrenia

Interventions

Aripiprazole

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Margaretta Nyilas
• Organization: Otsuka Pharmaceutical Development & Commercialization, Inc.

Margaretta.nyilas@otsuka-us.com

609-452-5673

Study Officials

• Margaretta Nyilas, M.D.

  Otsuka Pharmaceutical Development & Commercialization, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2005
• First Posted: January 20, 2005
• Study Start: July 1, 2004
• Primary Completion: August 1, 2006
• Study Completion: August 1, 2006
• Last Updated: August 10, 2012
• Results First Posted: August 1, 2012

Record last verified: 2012-08

Locations

US (53); PR (2)