Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
20 participants
INTERVENTIONAL
2004-04-30
2006-06-30
Brief Summary
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Detailed Description
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Antipsychotic medications such as Abilify are known to be effective for related conditions such as schizophrenia and are also used by some physicians in clinical settings in combination with mood stabilizing medications (Lithium, Depakote and others) to treat symptoms of bipolar disorder. Currently Abilify is approved by the FDA to treat schizophrenia and to treat bipolar disorder.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1
Aripiprazole
Patients were continued on treatment with their existing mood stabilizing medication, and upon enrollment were initiated on aripiprazole augmentation treatment. The initial starting dose of aripiprazole was 5 mg/day, with gradual upward titration as tolerated. Initiation of new additional antipsychotic medications was not permitted during the course of the study, and antipsychotic medications prescribed at study start were tapered and discontinued by week 4 of the study if possible.
Interventions
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Aripiprazole
Patients were continued on treatment with their existing mood stabilizing medication, and upon enrollment were initiated on aripiprazole augmentation treatment. The initial starting dose of aripiprazole was 5 mg/day, with gradual upward titration as tolerated. Initiation of new additional antipsychotic medications was not permitted during the course of the study, and antipsychotic medications prescribed at study start were tapered and discontinued by week 4 of the study if possible.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Must be age 50 or older
* Must have sub-optimal response to current psychotropic management including at least one of the following:
* Behaviors and symptoms of irritability, agitation, mood liability or diminished ability to interact with others in their place of residence
* Diminished ability to take care of basic personal needs in their place of residence due to symptoms of bipolar disorder
* Intolerance to current psychotropic medications; and
* Must live in the Northeast Ohio area.
Exclusion Criteria
* DSM-IV substance dependence (except nicotine or caffeine) within the past 3 months; or
* Receiving carbamazepine.
50 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
University Hospitals Cleveland Medical Center
OTHER
Responsible Party
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Case Western Reserve University
Principal Investigators
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Martha Sajatovic, MD
Role: PRINCIPAL_INVESTIGATOR
Case Western Reserve University School of Medicine
Countries
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References
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Sajatovic M, Coconcea N, Ignacio RV, Blow FC, Hays RW, Cassidy KA, Meyer WJ. Aripiprazole therapy in 20 older adults with bipolar disorder: a 12-week, open-label trial. J Clin Psychiatry. 2008 Jan;69(1):41-6. doi: 10.4088/jcp.v69n0106.
Other Identifiers
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10864-01-L0363
Identifier Type: -
Identifier Source: org_study_id