Study of Aripiprazole (Abilify) in Children With Symptoms of Mania

• Status: Completed
• Trial end date: 2011-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to look at the safety and effectiveness of aripiprazole (abilify) in children with bipolar disorder and to examine whether or not patients that respond to initial mood stabilization benefit from continued pharmacotherapy.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University Hospitals Cleveland Medical Center
• Collaborator: Bristol-Myers Squibb
• Treatments: Aripiprazole

Criteria

Inclusion Criteria:

• Outpatients ages 4-9 years (inclusive)

• Patients who are anticipated to have a Young Mania Rating Scale (Young et al. 1978) of 15 or higher at baseline

• Meet DSM-IV criteria for bipolar disorder type 1 or 2, 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 mood disorder 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.

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 a documented APZ dose as monotherapy treatment 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 disorders

• 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 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)