Aripiprazole in Children and Adolescents With Bipolar I Disorder

NCT00110461 | Completed Phase 3 Results

• 1 other identifier: 31-03-240
• Study Type: interventional
• Target: 296
• Locations: 1 country
• Sites: 53

Brief Summary

The purpose of this trial is to test the safety and efficacy of two doses of aripiprazole in child and adolescent patients with bipolar I disorder, manic or mixed episode with or without psychotic features.

Conditions

Bipolar Disorder

Keywords

Aripiprazole; Bipolar I Disorder, Manic or Mixed Episode with or without Psychotic Features

Outcome Measures

Primary Outcomes (1)

• Change in Young Mania Rating Scale (Y-MRS) Total Score at Week 4

  Change from Baseline to Week 4 in Y-MRS total score, using the last observation carried forward. Assessments performed at baseline and weekly through the acute phase (Week 4). (Also performed at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through the continuation phase.) The Y-MRS consists of 11 items assessing the core symptoms of mania. Each item has 5 grades of severity. Minimum score on the scale is 0 (absent or normal). Maximum score on the scale is 60 (worse outcome or more severe symptoms).

  Baseline and Week 4

Secondary Outcomes (29)

• Change in Young Mania Rating Scale (Y-MRS) Total Score at Week 30

  Baseline and Week 30

• Change in Children's Global Assessment Scale (CGAS) Total Score at Week 4

  Baseline and Week 4

• Change in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Mania Score at Week 4

  Baseline and Week 4

• Change in Children's Depression Rating Scale-Revised (CDRS-R) Total Score at Week 4

  Baseline and Week 4

• Change in General Behavior Inventory Scale (GBI) Total Parent/Guardian Version Mania Score at Week 4

  Baseline and Week 4

Study Arms (3)

1

ACTIVE COMPARATOR

Aripiprazole 10 mg tablet

Drug: Aripiprazole

2

ACTIVE COMPARATOR

Aripiprazole 30 mg tablet

Drug: Aripiprazole

3

PLACEBO COMPARATOR

Placebo

Drug: placebo

Interventions

Aripiprazole DRUG

Treatment Arm 1 (10 mg treatment arm): Aripiprazole 2 mg QD for 2 days, aripiprazole 5 mg QD for 2 days, and aripiprazole 10 mg QD as the target dose starting on Day 5. Subjects remained on the 10 mg dose for the remainder of the treatment period Subjects reached their target dose through a forced titration schedule and proceeded with treatment at their target dose until Week 4. If the subject reached Week 4, he or she continued into the Extension Phase, a 6-month double-blind treatment period, beginning at the same dose taken at the end of the Acute Phase.

1

placebo DRUG

Placebo tablet

3

Eligibility Criteria

• Age: 10 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Child and adolescent patients with bipolar I disorder, manic or mixed episode with or without psychotic features

You may not qualify if:

• Patients with certain other psychological disorders
• Patients with a co-morbid serious, uncontrolled systemic illness
• Patients with significant risk of committing suicide

Sponsors & Collaborators

• Otsuka Pharmaceutical Development & Commercialization, Inc.: lead

Study Sites (53)

Local Institution

Scottsdale, Arizona, United States

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Little Rock, Arkansas, 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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Stanford, 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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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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Tampa, Florida, United States

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Atlanta, Georgia, United States

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Smyrna, Georgia, United States

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Boise, Idaho, United States

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Chicago, Illinois, United States

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Libertyville, Illinois, United States

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Indianapolis, Indiana, United States

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Kansas City, Kansas, United States

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Newton, Kansas, United States

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Lexington, Kentucky, United States

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Baton Rouge, Louisiana, United States

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Lake Charles, Louisiana, United States

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Shreveport, Louisiana, United States

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Cambridge, Massachusetts, United States

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Medford, Massachusetts, United States

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Clinton Township, Michigan, United States

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Rochester Hills, Michigan, United States

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Kansas City, Missouri, United States

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St Louis, 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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Rochester, New York, United States

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Stony Brook, New York, United States

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Cincinnati, Ohio, United States

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Cleveland, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Philadelphia, Pennsylvania, United States

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Charleston, South Carolina, United States

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Memphis, Tennessee, United States

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Bellaire, Texas, United States

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Fort Worth, Texas, United States

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Houston, Texas, United States

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San Antonio, Texas, United States

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Herndon, Virginia, 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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Milwaukee, Wisconsin, United States

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Related Publications (4)

• Youngstrom E, Zhao J, Mankoski R, Forbes RA, Marcus RM, Carson W, McQuade R, Findling RL. Clinical significance of treatment effects with aripiprazole versus placebo in a study of manic or mixed episodes associated with pediatric bipolar I disorder. J Child Adolesc Psychopharmacol. 2013 Mar;23(2):72-9. doi: 10.1089/cap.2012.0024. Epub 2013 Mar 12.

  PMID: 23480324 DERIVED

• Findling RL, Correll CU, Nyilas M, Forbes RA, McQuade RD, Jin N, Ivanova S, Mankoski R, Carson WH, Carlson GA. Aripiprazole for the treatment of pediatric bipolar I disorder: a 30-week, randomized, placebo-controlled study. Bipolar Disord. 2013 Mar;15(2):138-49. doi: 10.1111/bdi.12042.

  PMID: 23437959 DERIVED

• Mankoski R, Zhao J, Carson WH, Mathew SJ, Forbes RA. Young mania rating scale line item analysis in pediatric subjects with bipolar I disorder treated with aripiprazole in a short-term, double-blind, randomized study. J Child Adolesc Psychopharmacol. 2011 Aug;21(4):359-64. doi: 10.1089/cap.2010.0100. Epub 2011 Aug 8.

  PMID: 21823911 DERIVED

• Findling RL, Nyilas M, Forbes RA, McQuade RD, Jin N, Iwamoto T, Ivanova S, Carson WH, Chang K. Acute treatment of pediatric bipolar I disorder, manic or mixed episode, with aripiprazole: a randomized, double-blind, placebo-controlled study. J Clin Psychiatry. 2009 Oct;70(10):1441-51. doi: 10.4088/JCP.09m05164yel.

  PMID: 19906348 DERIVED

MeSH Terms

Conditions

Bipolar Disorder; Mania

Interventions

Aripiprazole

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Limitations and Caveats

Primary efficacy endpoint is change from baseline in Y-MRS total score. Only randomized subjects with both baseline and 1+ post-baseline were included in primary efficacy analysis so # randomized is different from # included in the efficacy analysis.

Results Point of Contact

• Title: Andy Forbes
• Organization: Otsuka Pharmaceutical Development & Commercialization, Inc.

andy.forbes@otsuka-us.com

Study Officials

• Margaretta Nyilas, MD

  Otsuka Pharmaceutical Development & Commercialization, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

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

Study Record Dates

• First Submitted: May 9, 2005
• First Posted: May 10, 2005
• Study Start: March 1, 2005
• Primary Completion: February 1, 2007
• Study Completion: February 1, 2007
• Last Updated: May 21, 2012
• Results First Posted: May 21, 2012

Record last verified: 2012-04

Locations

US (53)