Study of Aripiprazole (Abilify) in Children With Symptoms of Mania
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Intervention: Aripiprazole; Placebo
Intervention description: dosing will occur at 2mg, 5mg, 7mg, 10 mg, 12mg, or 15 mg based on weight, side effects and efficacy; subjects in phase 2 will be randomized to active abilify or placebo
Intervention MeSH terms: Aripiprazole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 60.0
Sex: All
Minimum age: 4 Years
Maximum age: 9 Years
Healthy volunteers: Accepts Healthy Volunteers

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.
    

Eligibility 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)