Study of Aripiprazole (Abilify) in Children With Symptoms of Mania
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Aripiprazole in Children With Symptoms of Mania|
- Time in Weeks to Discontinuation [ Time Frame: up to 72 weeks ] [ Designated as safety issue: No ]Time in weeks to discontinuation due to any reason, including mood event, adverse event, or other.
|Study Start Date:||August 2004|
|Study Completion Date:||January 2011|
|Primary Completion Date:||January 2011 (Final data collection date for primary outcome measure)|
Active Comparator: Aripiprazole
Phase I and Phase III are open label Abilify phases where all subjects receive active Abilify
dosing will occur at 2mg, 5mg, 7mg, 10 mg, 12mg, or 15 mg based on weight, side effects and efficacy
Other Name: Abilify
Placebo Comparator: Placebo
in Phase 2 subjects are randomized to either placebo or abilify for up to 72 weeks
subjects in phase 2 will be randomized to active abilify or placebo
Other Name: Placebo
This outpatient study will be conducted in 3 phases. Phase 1: Patients meeting entry criteria will be treated with open label 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 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00194077
|United States, Ohio|
|University Hospitals Case Medical Center|
|Cleveland, Ohio, United States, 44106|
|Principal Investigator:||Robert L Findling, MD||Johns Hopkins University|