Study of Aripiprazole (Abilify) Versus Placebo in Children With Subsyndromal Bipolar Disorder - Full Text View

Purpose

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 bipolar parent and other family member with a mood disorder.

Condition	Intervention	Phase
Bipolar Disorder	Drug: abilify (aripiprazole)	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Aripiprazole in At-Risk Children With Symptoms of Bipolar Disorder

Resource links provided by NLM:

MedlinePlus related topics: Bipolar Disorder

Drug Information available for: Aripiprazole

U.S. FDA Resources

Further study details as provided by University Hospitals of Cleveland:

Primary Outcome Measures:

YMRS [ Time Frame: Baseline and last study visit ] [ Designated as safety issue: No ]

Enrollment:	60
Study Start Date:	August 2004
Study Completion Date:	June 2012
Primary Completion Date:	May 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: placebo	Drug: abilify (aripiprazole) dosing is 2mg, 5mg, 7mg, 10mg, 12mg or 15 mg depending on response and during the double blind arms may be randomized to placebo
Active Comparator: abilify	Drug: abilify (aripiprazole) dosing is 2mg, 5mg, 7mg, 10mg, 12mg or 15 mg depending on response and during the double blind arms may be randomized to placebo

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 APZ; 2) participated in the blinded portion of the clinical trial for a minimum of 4 weeks.

Eligibility

Ages Eligible for Study:	5 Years to 17 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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 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 (K-SADS-PL supplemented with sections from the WASH-U 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00194012

Locations

United States, Ohio
University Hospitals Case Medical Center - Walker Building
Cleveland, Ohio, United States, 44106

Sponsors and Collaborators

University Hospitals of Cleveland

Bristol-Myers Squibb

Investigators

Principal Investigator:

Robert L Findling, MD

University Hospitals of Cleveland

More Information

No publications provided

Responsible Party:	Robert L Findling, MD, Director, Division of Child and Adolescent Psychiatry, University Hospitals of Cleveland
ClinicalTrials.gov Identifier:	NCT00194012 History of Changes
Other Study ID Numbers:	At Risk
Study First Received:	September 11, 2005
Last Updated:	June 12, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by University Hospitals of Cleveland:

bipolar disorder

Additional relevant MeSH terms:

Bipolar Disorder
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Aripiprazole
Antipsychotic Agents
Tranquilizing Agents

Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on May 19, 2013