Clinical trial NCT00194012: Study of Aripiprazole (Abilify) Versus Placebo in Children With Subsyndromal Bipolar Disorder
Official title: Aripiprazole in At-Risk Children With Symptoms of Bipolar Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bipolar Disorder
Keywords: bipolar disorder
Lead sponsor: University Hospitals Cleveland Medical Center
Sponsor class: OTHER
Collaborators: name: Bristol-Myers Squibb
First posted: 2005-09-19
Enrollment: 62
Sex: ALL
Minimum age (years): 5
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Young Mania Rating Scale (YMRS)
timeFrame: Baseline
measure: Young Mania Rating Scale (YMRS)
timeFrame: 12 weeks
measure: Young Mania Rating Scale (YMRS)
timeFrame: Open-Label Extension - 6 weeks
Secondary outcomes:
measure: Children's Depression Rating Scale-Revised (CDRS-R )
timeFrame: Baseline
measure: CDRS-R Children's Depression Rating Scale-Revised
timeFrame: 12 weeks
measure: CDRS-R Children's Depression Rating Scale-Revised
timeFrame: Open-Label Extension - 6 weeks
measure: Children's Global Assessment Scale (CGAS)
timeFrame: Baseline
measure: Children's Global Assessment Scale (CGAS)
timeFrame: 12 weeks
measure: Children's Global Assessment Scale (CGAS)
timeFrame: Open-Label Extension - 6 weeks
measure: Clinical Global Impressions Scale (CGI-Severity)
timeFrame: Baseline
measure: Clinical Global Impressions Scale (CGI-Severity)
timeFrame: 12 weeks
measure: Clinical Global Impressions Scale (CGI-Severity)
timeFrame: Open-Label Extension - 6 weeks
measure: Attention Deficit Hyperactivity Disorder (ADHD) Rating Scale IV or (ARS-IV)
timeFrame: Baseline
measure: Attention Deficit Hyperactivity Disorder (ADHD) Rating Scale IV or (ARS-IV)
timeFrame: 12 weeks
measure: Attention Deficit Hyperactivity Disorder (ADHD) Rating Scale IV or (ARS-IV)
timeFrame: Open-Label Extension - 6 weeks
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: University Hospitals Case Medical Center - Walker Building
state: Ohio
Study officials:
affiliation: Johns Hopkins University
name: Robert L Findling, MD
role: PRINCIPAL_INVESTIGATOR
References: