Aripiprazole in Late Life Bipolar Disorder

Study Overview
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Brief Summary
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The purpose of this research study is to analyze the effectiveness and tolerability of a new medication, aripiprazole (Abilify), in individuals age 50 years and older who have bipolar disorder (manic-depressive illness).

Detailed Description
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While medications such as valproate (Depakote and others) and lithium are generally considered first-line agents in late life bipolar disorder, side effects are common, and many individuals with bipolar disorder continue to have symptoms in spite of medication treatment. A continuing unmet need is the availability of medications that are generally well- tolerated and effective in later life bipolar disorders. 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.

Official Title
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Aripiprazole in Late Life Bipolar Disorder

Conditions
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Bipolar Disorder

Intervention / Treatment
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* Drug: Aripiprazole


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must have Bipolar disorder as confirmed by the Mini Neuropsychiatric Interview (MINI) 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: An unstable medical illness, or a medical illness, which in the opinion of the study investigators, is likely to affect the outcome of the study DSM-IV substance dependence (except nicotine or caffeine) within the past 3 months; or Receiving carbamazepine.

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Aripiprazole<br>* 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.<br>* Other names: Abilify;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure and pulse |  | 12 weeks | 
| Weight |  | 12 weeks | 
| Abnormal Involuntary Movement Scale (AIMS) |  | 12 weeks | 
| Barnes Akathisia Scale (BAS) |  | 12 weeks | 
| Simpson Angus Neurological Rating Scale (SAS) |  | 12 weeks | 
| Basic serum chemistry - screening and 12/study end |  | 12 weeks | 
| Complete blood count (CBC) with differential - screening and 12/study end |  | 12 weeks | 
| Electrocardiogram - screening and 12/study end |  | 12 weeks | 
| Young Mania Rating Scale (YMRS) - screening, baseline, and weeks 1, 2, 4, 8, and 12/study end |  | 12 weeks | 
| Hamilton Depression Rating Scale (HAM-D) - screening, baseline, and weeks 1, 2, 4, 8, and 12/study end |  | 12 weeks | 
| Clinical Global Impression (CGI) |  | 12 weeks | 
| Global Assessment Scale (GAS) |  | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bipolar Disorder, Geriatric Psychiatry, Aripiprazole