Bipolar Disorder
Conditions
Keywords
Bipolar Disorder, Geriatric Psychiatry, Aripiprazole
Brief summary
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
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.
Interventions
DRUGAripiprazole
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.
Sponsors
Bristol-Myers Squibb
University Hospitals Cleveland Medical Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | 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 |
Outcome results
None listed