CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 62 enrolled
Drug / intervention
Aripiprazole +1 moredrug
Likely dose
Not stated in record
Key inclusion· 6
  • ✓Ages 5-17 years
  • ✓Substantial symptoms of mania, depression, or both within the past 2 weeks warranting pharmacological treatment
  • ✓Meets DSM-IV criteria for cyclothymia or bipolar disorder not otherwise specified (BP NOS) on K-SADS-PL and clinical psychiatrist interview
  • ✓At least one parent with bipolar spectrum disorder documented via MINI or Family History Method
Key exclusion· 11
  • ✕History of intolerance to aripiprazole at doses of 0.1 mg/kg/day
  • ✕Prior documented response to aripiprazole monotherapy (manic episode treated with aripiprazole at 0.2 mg/kg/day)
  • ✕Autistic disorder, Asperger's disorder, Rett's syndrome, or other pervasive developmental disorder
  • ✕Mental retardation

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00194012
NCT00194012Phase 3Completed
CompareCT.gov

Aripiprazole in At-Risk Children With Symptoms of Bipolar Disorder

University Hospitals Cleveland Medical Center·interventional·Posted Sep 19, 2005·Updated Jun 26, 2017

In Brief

A Phase 3 clinical trial evaluating Aripiprazole and Placebo for Bipolar Disorder. Completed, enrolled 62 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBipolar Disorder
CountriesUnited States
CollaboratorsBristol-Myers Squibb

Timeline

Phase 3CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 19, 2005
Enrollment StartAug 1, 2004
Primary CompletionMay 1, 2012
Study CompletionJun 1, 2012
TodayJul 2, 2026
Enrollment to primary: 7.8 yearsPosted 20.8 years ago

Interventions

Aripiprazoledrug

Addressed in arm description.

Placebodrug

Addressed in arm description.