Study of Aripiprazole (Abilify) Versus Placebo in Children With Subsyndromal Bipolar Disorder

NCT ID: NCT00194012

Last Updated: 2017-06-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-08-31
• Study Completion Date: 2012-06-30

Brief Summary

The purpose of this study is to test the effectiveness and tolerability/safety of aripiprazole (Abilify) in children with subsyndromal symptoms of bipolar disorder who also have a parent with bipolar disorder and other family member with a mood disorder.

Detailed Description

This will be a double-blind, placebo-controlled, parallel-arm, randomized clinical trial that will last up to 12 weeks.

This placebo-controlled portion will be followed by a 6-week open label extension/stabilization phase. In order to be eligible for participation in the extension/stabilization phase, subjects must: 1) in the investigator's opinion have had no dose-limiting side effects likely to be attributable to aripiprazole (APZ); 2) participated in the blinded portion of the clinical trial for a minimum of 4 weeks.

Conditions

Bipolar Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Aripiprazole-Randomized Phase

Patients randomly assigned to aripiprazole received medication in pill form with dosing at 2mg, 5mg, 7mg, 10mg, 12mg or 15mg depending on their response.

Group Type: ACTIVE_COMPARATOR

Aripiprazole

Intervention Type: DRUG

Addressed in arm description.

Placebo-Randomized Phase

Patients randomly assigned to placebo received pills/dosing made to look identical to the aripiprazole.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Addressed in arm description.

Interventions

Aripiprazole

Addressed in arm description.

Intervention Type: DRUG

Placebo

Addressed in arm description.

Intervention Type: DRUG

Other Intervention Names

Abilify

Eligibility Criteria

Inclusion Criteria

• Outpatients ages 5-17 years (inclusive)
• Patients, who in the investigator's opinion have substantial symptoms of mania, depression, or both within the past 2 weeks such that treatment with a pharmacological agent is warranted
• Currently meets Diagnostic Statistical Manual of Mental Disorders (DSM-IV) criteria for either cyclothymia, or bipolar disorder not otherwise specified (BP NOS) based on the results of both a semi-structured diagnostic research assessment, Present and Lifetime Version (K-SADS-Present and Lifetime (PL) supplemented with sections from the Washington University K-SADS) (Geller et al., 2001; Kaufman et al., 1997) and a clinical interview with a child and adolescent psychiatrist.
• Offspring of a parent with a bipolar spectrum disorder (based on the results of either the Mini International Neuropsychiatric Interview (MINI)(Sheehan et al., 1998) or the Family History Method (FH-RDC)(Andreasen et al., 1977)
• Has another first or second degree relative with a mood disorder determined by the results of either the MINI or the FH-RDC
• Has participated in at least 4 sessions of psychotherapy specifically focused on the symptoms/management of pediatric mood disorder and continues to have clinically significant symptomatology

Exclusion Criteria

• Patients who have a history of intolerance to APZ at doses of 0.1mg/kg/day
• Patients who have experienced a manic episode with documented treatment with APZ monotherapy at a dose of 0.2 mg/kg/day
• Patients with an active neurological/medical disorder for which treatment with APZ would be contraindicated
• Patients with clinical evidence of autistic disorder, Asperger's disorder, Rett's syndrome or other pervasive developmental disorder
• Patients with clinical evidence of mental retardation
• Patients who are known to be allergic or hypersensitive to aripiprazole
• Patients who are unable to swallow pills/capsules
• Patients for whom the need for hospitalization during the course of the study appears likely
• Patients who have started a new psychotherapeutic intervention within less than 4 weeks of randomization
• Patients who have a general medical or neurological condition (including clinically significant abnormalities on screening laboratories) that may be considered to be the etiology of the patient's mood disorder
• Patients who have a general medical or neurological condition for which treatment with an atypical antipsychotic would be contraindicated (e.g. tardive dyskinesia)
• Patients who have a general medical or neurological condition that could interfere with the interpretation of clinical response to APZ treatment
• Patients taking psychotropic agents (other than psychostimulants) within one week of baseline (2 weeks for fluoxetine; 3 days for psychostimulants)
• Patients with a suicide attempt requiring medical/psychiatric care within the past 6 months
• Has met DSM-IV criteria for drug/alcohol abuse or dependence within the past 6 months
• Females who are currently pregnant or lactating
• Sexually active females, who in the investigators' opinion are not using an adequate form of birth control

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Bristol-Myers Squibb

INDUSTRY

Sponsor Role: collaborator

University Hospitals Cleveland Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Robert L Findling, MD

Director, Division of Child and Adolescent Psychiatry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Robert L Findling, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

University Hospitals Case Medical Center - Walker Building

Cleveland, Ohio, United States

Countries

United States

Other Identifiers

At Risk

Identifier Type: -

Identifier Source: org_study_id