study of aripiprazole (abilify) versus placebo in children with subsyndromal bipolar disorder

Conditions: Bipolar Disorder

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.

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

Keywords: bipolar disorder