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Study of Aripiprazole (Abilify) Versus Placebo in Children With Subsyndromal Bipolar Disorder
This study is currently recruiting participants.
Study NCT00194012   Information provided by University Hospitals of Cleveland
First Received: September 11, 2005   Last Updated: February 12, 2009   History of Changes
This Tabular View shows the required WHO registration data elements as marked by

September 11, 2005
February 12, 2009
August 2004
YMRS [ Time Frame: Baseline and last study visit ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00194012 on ClinicalTrials.gov Archive Site
 
 
 
Study of Aripiprazole (Abilify) Versus Placebo in Children With Subsyndromal Bipolar Disorder
Aripiprazole in At-Risk Children With Symptoms of Bipolar Disorder

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.

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.

Phase III
Interventional
Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Bipolar Disorder
Drug: abilify
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
60
 
January 2010   (final data collection date for primary outcome measure)

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
Both
5 Years to 17 Years
Yes
Contact: Nicole Kovach, BA 216-844-3922 nicole.kovach@uhhospitals.org
Contact: Denise Bedoya, MA 216-844-4964 denise.delportobedoya@uhhospitals.org
United States
 
 
NCT00194012
Robert L Findling, MD, University Hospitals Case Medical Center
 
University Hospitals of Cleveland
Bristol-Myers Squibb
Principal Investigator: Robert L Findling, MD University Hospitals of Cleveland
University Hospitals of Cleveland
February 2009

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.