Cleveland, Ohio 44106

  • Bipolar Disorder

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.


Study summary:

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.


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


NCT ID:

NCT00194012


Primary Contact:

Principal Investigator
Robert L Findling, MD
University Hospitals of Cleveland


Backup Contact:

N/A


Location Contact:

Cleveland, Ohio 44106
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: April 07, 2020

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