CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 60 enrolled
Drug / intervention
Aripiprazole +1 moredrug
Likely dose
Aripiprazole 2-15 mg orally daily (dosing by weight, side effects, and efficacy)AI-extracted
Key inclusion· 4
  • ✓Ages 4-9 years (inclusive)
  • ✓Anticipated Young Mania Rating Scale score ≥15 at baseline
  • ✓DSM-IV diagnosis of bipolar disorder type 1 or 2, cyclothymia, or bipolar disorder not otherwise specified (BP NOS)
  • ✓Diagnosis confirmed by both semi-structured diagnostic interview (K-SADS-PL supplemented with mood disorder sections from WASH-U K-SADS) and clinical interview with a child and adolescent psychiatrist
Key exclusion· 9
  • ✕History of intolerance to aripiprazole at doses of 0.1 mg/kg/day or higher
  • ✕Prior manic episode with documented aripiprazole monotherapy at 0.2 mg/kg/day or higher
  • ✕Known allergy or hypersensitivity to aripiprazole
  • ✕Clinical evidence of autistic disorder, Asperger's disorder, Rett's syndrome, or other pervasive developmental disorders

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

Search/NCT00194077
NCT00194077Phase 3Completed
CompareCT.gov

Aripiprazole in Children With Symptoms of Mania

University Hospitals Cleveland Medical Center·interventional·Posted Sep 19, 2005·Updated Jan 7, 2015

In Brief

A Phase 3 clinical trial evaluating Aripiprazole and Placebo for Bipolar Disorder. Completed, enrolled 60 participants across 1 site.

Detailed 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.

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 CompletionJan 1, 2011
TodayJul 2, 2026
Enrollment to primary: 6.4 yearsPosted 20.8 years ago

Interventions

Aripiprazoledrug

dosing will occur at 2mg, 5mg, 7mg, 10 mg, 12mg, or 15 mg based on weight, side effects and efficacy

Placebodrug

subjects in phase 2 will be randomized to active abilify or placebo