Study of Aripiprazole (Abilify) in Children With Symptoms of Mania
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Study type: Interventional
Phase: Phase 3

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.
    

Detailed description: 
      This outpatient study will be conducted in 3 phases. Phase 1: Patients meeting entry criteria
      will be treated with open label aripiprazole (APZ) in order to achieve therapeutic doses of
      this agent. The primary objective of this phase is to stabilize the patient's mood prior to
      randomization in phase 2. Adjunctive treatment of attention-deficit hyperactivity disorder
      (ADHD) will be permitted during this phase after week 6 of phase 1. In order to be entered
      into Phase 2, patients must be clinically stable based on a priori criteria (see below). The
      maximum allowable duration of Phase 1 will be 16 weeks. Only patients who have achieved
      syndromal remission (not just improvement) will be eligible for randomization into phase 2.

      Phase 2: Patients that achieve syndromal remission during Phase 1 will be randomized in a
      double-blind fashion to receive either ongoing APZ therapy or placebo therapy during Phase 2.
      Patients who are receiving co-administration of ADHD pharmacotherapy may continue with this
      during Phase 2. Patients will have an equal chance of being assigned to each of the 2
      treatment arms. Randomization strata will be based on whether or not the subject is receiving
      ADHD pharmacotherapy and whether or not the subject is suffering from Bipolar 1 or 2
      disorders. The maximum length of time a patient may remain in phase 2 will be 72 weeks.
      Youths who develop a major depressive episode, a manic, or mixed episode, or youths for whom
      continued enrollment in this phase of study is contraindicated (as determined by the patient,
      guardian, research team or study physician), will be withdrawn from phase 2. Youths who
      withdraw from phase 2 may enter Phase 3. Reason for removal from phase 2 will be documented.
      For those youths who successfully complete 72 weeks of participation in phase 2, trial
      participation will be ended. Those patients who complete phase 2 will receive follow up
      clinical care either at University Hospitals-Cleveland (UHC) or with a community-based
      physician.

      Phase 3: For youths who are withdrawn during phase 2, 8-weeks of open-label treatment with
      APZ will be available
    

Intervention name(s): Aripiprazole; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 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
Other intervention name(s): Abilify
Intervention MeSH terms: Aripiprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment