Aripiprazole in Children and Adolescents With Bipolar I Disorder - Full Text View

Sponsored by:	Otsuka Pharmaceutical Development & Commercialization, Inc.
Information provided by:	Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier:	NCT00110461

Purpose

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.

Condition	Intervention	Phase
Bipolar Disorder	Drug: Aripiprazole Drug: placebo	Phase III

MedlinePlus related topics: Bipolar Disorder Psychotic Disorders

Drug Information available for: Aripiprazole

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Phase III Trial 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

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

Primary Outcome Measures:

The primary efficacy measure for the study was the change from baseline to Week 4 (Acute Phase) on the Young Mania Rating Scale (Y-MRS) total score. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change from baseline (to be evaluated at each visit) in the Y-MRS total score. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
The Children's Global Assessment Scale (CGAS) score. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Clinical Global Impressions Scale-Bipolar Version (CGI-BP) severity score [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
The Children's Depression Rating Scale-Revised (CDRS-R) score [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
General Behavior Inventory Scale (GBI) score [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Attention Deficit Hyperactivity Disorders Rating Scale (ADHD-RS-IV) score [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
The frequency by severity of AEs, SAEs (clinical and laboratory), and discontinuation from study due to adverse events through Week 30 [ Time Frame: 30 weeks ] [ Designated as safety issue: Yes ]
Change from baseline by visit up through Week 30 on the SAS score, the AIMS score, and the BARS score [ Time Frame: 30 weeks ] [ Designated as safety issue: Yes ]

Enrollment:	296
Study Start Date:	March 2005
Study Completion Date:	February 2007
Primary Completion Date:	February 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Aripiprazole 10 mg tablet	Drug: Aripiprazole 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.
2: Active Comparator Aripiprazole 30 mg tablet	Drug: Aripiprazole Treatment Arm 2 (30 mg treatment arm): Aripiprazole 2 mg QD for 2 days, aripiprazole 5 mg QD for 2 days, aripiprazole 10 mg QD for 2 days, aripiprazole 15 mg QD for 2 days, aripiprazole 20 mg QD for 2 days, aripiprazole 25 mg QD for 2 days, and aripiprazole 30 mg QD as the target dose starting on Day 13. Subjects remained on the 30 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.
3: Placebo Comparator Placebo	Drug: placebo Placebo tablet

Eligibility

Ages Eligible for Study:	10 Years to 17 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00110461

Show 55 Study Locations

Sponsors and Collaborators

Otsuka Pharmaceutical Development & Commercialization, Inc.

Investigators

Study Director:

Margaretta Nyilas, MD

Otsuka Pharmaceutical Development & Commercialization, Inc.

More Information

Responsible Party:	Northwest Clinical Research Center ( Arifulla Khan, MD )
Study ID Numbers:	31-03-240
Study First Received:	May 9, 2005
Last Updated:	December 21, 2007
ClinicalTrials.gov Identifier:	NCT00110461
Health Authority:	United States: Food and Drug Administration

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

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

Study placed in the following topic categories:

Affective Disorders, Psychotic
Mental Disorders
Bipolar Disorder

Mood Disorders
Psychotic Disorders
Aripiprazole

Additional relevant MeSH terms:

Tranquilizing Agents
Pathologic Processes
Disease
Therapeutic Uses
Physiological Effects of Drugs

Psychotropic Drugs
Central Nervous System Depressants
Antipsychotic Agents
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009