Status:
COMPLETED
Study of Aripiprazole (Abilify) in Children With Symptoms of Mania
Lead Sponsor:
University Hospitals Cleveland Medical Center
Collaborating Sponsors:
Bristol-Myers Squibb
Conditions:
Bipolar Disorder
Eligibility:
All Genders
4-9 years
Phase:
PHASE3
Brief 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 sta...
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. Th...
Eligibility Criteria
Inclusion
- Outpatients ages 4-9 years (inclusive)
- Patients who are anticipated to have a Young Mania Rating Scale (Young et al. 1978) of 15 or higher at baseline
- Meet DSM-IV criteria for bipolar disorder type 1 or 2, cyclothymia, or bipolar disorder not otherwise specified (BP NOS) based on the results of both a semi-structured diagnostic research assessment (K-SADS-PL supplemented with mood disorder sections from the WASH-U K-SADS) (Geller et al., 2001; Kaufman et al., 1997) and a clinical interview with a child and adolescent psychiatrist.
Exclusion
- Patients who have a history of intolerance to APZ at doses of 0.1mg/kg/day
- Patients who have experienced a manic episode with a documented APZ dose as monotherapy treatment of 0.2 mg/kg/day
- Patients with an active neurological/medical disorder for which treatment with APZ would be contraindicated
- Patients with clinical evidence of autistic disorder, Asperger's disorder, Rett's syndrome or other pervasive developmental disorders
- Patients with clinical evidence of mental retardation
- Patients who are known to be allergic or hypersensitive to aripiprazole
- Patients who are unable to swallow pills/capsules
- Patients for whom the need for hospitalization during the course of the study appears likely
- Patients who have a general medical or neurological condition (including clinically significant abnormalities on screening laboratories) that may be considered to be the etiology of the patient's mood disorder
- Patients who have a general medical or neurological condition for which treatment with an atypical antipsychotic would be contraindicated (e.g. tardive dyskinesia)
- Patients who have a general medical or neurological condition that could interfere with the interpretation of clinical response to APZ treatment
- Patients taking psychotropic agents (other than psychostimulants) within one week of baseline (2 weeks for fluoxetine; 3 days for psychostimulants)
Key Trial Info
Start Date :
August 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00194077
Start Date
August 1 2004
End Date
January 1 2011
Last Update
January 7 2015
Active Locations (1)
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1
University Hospitals Case Medical Center
Cleveland, Ohio, United States, 44106