Status:
COMPLETED
Study of Aripiprazole (Abilify) Versus Placebo in Children With Subsyndromal Bipolar Disorder
Lead Sponsor:
University Hospitals Cleveland Medical Center
Collaborating Sponsors:
Bristol-Myers Squibb
Conditions:
Bipolar Disorder
Eligibility:
All Genders
5-17 years
Phase:
PHASE3
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 ...
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 extensi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT00194012
Start Date
August 1 2004
End Date
June 1 2012
Last Update
June 26 2017
Active Locations (1)
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1
University Hospitals Case Medical Center - Walker Building
Cleveland, Ohio, United States, 44106