Study of Aripiprazole (Abilify) Versus Placebo in Children With Subsyndromal Bipolar Disorder
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 bipolar parent and other family member with a mood disorder.
|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 At-Risk Children With Symptoms of Bipolar Disorder|
- Youth Mania Rating Scale (YMRS) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]The Young Mania Rating Scale (YMRS) has 11 items and is based on the patient's subjective report of his or her clinical condition over the previous 48 hours. Additional information is based upon clinical observations made during the course of the clinical interview. The items are selected based upon published descriptions of the core symptoms of mania. Each item o the YMRS is given a severity rating. There are four items that are graded on a 0 to 8 scale (irritability, speech, thought content, and disruptive/aggressive behavior), while the remaining seven items are graded on a 0 to 4 scale. These four items are given twice the weight of the others to compensate for poor cooperation from severely ill patients. There are well described anchor points for each grade of severity. Total score ranges from 0 to 60, with higher being more severe mania.
|Study Start Date:||August 2004|
|Study Completion Date:||June 2012|
|Primary Completion Date:||May 2012 (Final data collection date for primary outcome measure)|
Patients randomly assigned to placebo, a drug reduction schedule was generated so that the taper of medication occured over the course of the first 4 weeks of phase 2.
Addressed in arm description
Other Name: Placebo
Active Comparator: Aripiprazole
Patients randomly assigned to aripiprazole, attempts were made to keep doses of aripiprazole consistent during the course of phase 2.
Addressed in arm description
Other Name: Abilify
This will be a double-blind, placebo-controlled, parallel-arm, randomized clinical trial that will last up to 12 weeks.
This placebo-controlled portion will be followed by a 6-week open label extension/stabilization phase. In order to be eligible for participation in the extension/stabilization phase, subjects must: 1) in the investigator's opinion have had no dose-limiting side effects likely to be attributable to APZ (aripiprazole) ; 2) participated in the blinded portion of the clinical trial for a minimum of 4 weeks.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00194012
|United States, Ohio|
|University Hospitals Case Medical Center - Walker Building|
|Cleveland, Ohio, United States, 44106|
|Principal Investigator:||Robert L Findling, MD||Johns Hopkins University|