Status:
COMPLETED
An Open-Label Trial of Aripiprazole in Children and Adolescents With Bipolar Disorder
Lead Sponsor:
University of Cincinnati
Collaborating Sponsors:
Children's Hospital Medical Center, Cincinnati
Bristol-Myers Squibb
Conditions:
Bipolar Disorder
Eligibility:
All Genders
7-18 years
Phase:
PHASE3
Brief Summary
This is an investigator-initiated study whose primary aim is to determine the effectiveness of aripiprazole (Abilify®) in helping persons with symptoms of mania whose current medications do not comple...
Detailed Description
The primary aim of this study is to assess the effectiveness, safety, and tolerability of aripiprazole for the treatment of children and adolescents with bipolar disorder. The secondary aim of this st...
Eligibility Criteria
Inclusion
- Male or Females; between the ages of 7 years 0 months to 17 years 12 months
- Bipolar I Disorder, mixed or manic episode, psychotic or non-psychotic, according to DSM IV criteria.
- Score of \> 20 on the Y-MRS at baseline.
- Ability and willingness to provide assent and informed written consent from at least one parent or legal guardian
- No current general medical illnesses requiring medication that would effect interpretation of study outcomes.
- Subjects must have at least normal intelligence.
- Female patients of childbearing potential must be using a reliable method of contraception, e.g. hormonal contraceptives, Depo-Provera, double-barrier methods (e.g. condom and diaphragm, condom and foam, condom and sponge) or abstinence). Females of childbearing potential must have a negative serum pregnancy test immediately prior to study entry.
- Must be able to swallow oral medication (tablets).
Exclusion
- A current or lifetime DSM-IV diagnosis of schizophrenia, autistic disorder, schizoaffective disorder, pervasive developmental disorder, or obsessive compulsive disorder
- Known IQ \< 70
- Patients with high suicide risk defined as any serious suicide attempt that required medical intervention or current suicide risk that cannot be safely managed as determined by the clinical judgment of the investigator.
- Concurrent cognitive behavioral psychotherapy.
- Present or past (within 3 months) DSM-IV diagnosis of substance abuse/dependence.
- Female patients who are pregnant, trying to become pregnant, nursing an infant, or not using a reliable form of contraception.
- Bipolar subjects who are currently stable on mood stabilizers or atypical neuroleptics.
- Patient has failed on a previous adequate course of aripiprazole.
- A known hypersensitivity to aripiprazole or to any of its components.
- Participated in an investigational drug/device trial within the last 30 days.
- Patients with severe renal insufficiency, defined as creatinine clearance \<30ml/min. by history or by lab findings.
- \-
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2008
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00221416
Start Date
June 1 2005
End Date
December 1 2008
Last Update
June 27 2013
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