Study of Aripiprazole (Abilify) Versus Placebo in Children With Subsyndromal Bipolar Disorder
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Intervention: Aripiprazole; Placebo
Intervention description: Addressed in arm description.; Addressed in arm description.
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: 62.0
Sex: All
Minimum age: 5 Years
Maximum age: 17 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: 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.
    

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