| September 13, 2005 |
| January 23, 2009 |
| April 2004 |
| June 2006 (final data collection date for primary outcome measure) |
- Blood pressure and pulse - screening, baseline, and weeks 1, 2, 4, 8, and 12/study end [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
- Weight - screening, baseline, and weeks 1, 2, 4, 8, and 12/study end [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Abnormal Involuntary Movement Scale (AIMS) - screening, baseline, and weeks 1, 2, 4, 8, and 12/study end [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Barnes Akathisia Scale (BAS) - screening, baseline, and weeks 1, 2, 4, 8, and 12/study end [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Simpson Angus Neurological Rating Scale (SAS) - screening, baseline, and weeks 1, 2, 4, 8, and 12/study end [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Basic serum chemistry - screening and 12/study end [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
- Complete blood count (CBC) with differential - screening and 12/study end [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
- Electrocardiogram - screening and 12/study end [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
- Young Mania Rating Scale (YMRS) - screening, baseline, and weeks 1, 2, 4, 8, and 12/study end [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Hamilton Depression Rating Scale (HAM-D) - screening, baseline, and weeks 1, 2, 4, 8, and 12/study end [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Clinical Global Impression (CGI) - screening, baseline, and weeks 1, 2, 4, 8, and 12/study end [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Global Assessment Scale (GAS) - screening, baseline, and weeks 1, 2, 4, 8, and 12/study end [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
|
- Blood pressure and pulse - screening, baseline, and weeks 1, 2, 4, 8, and 12/study end
- Weight - screening, baseline, and weeks 1, 2, 4, 8, and 12/study end
- Abnormal Involuntary Movement Scale (AIMS) - screening, baseline, and weeks 1, 2, 4, 8, and 12/study end
- Barnes Akathisia Scale (BAS) - screening, baseline, and weeks 1, 2, 4, 8, and 12/study end
- Simpson Angus Neurological Rating Scale (SAS) - screening, baseline, and weeks 1, 2, 4, 8, and 12/study end
- Basic serum chemistry - screening and 12/study end
- Complete blood count (CBC) with differential - screening and 12/study end
- Electrocardiogram - screening and 12/study end
- Young Mania Rating Scale (YMRS) - screening, baseline, and weeks 1, 2, 4, 8, and 12/study end
- Hamilton Depression Rating Scale (HAM-D) - screening, baseline, and weeks 1, 2, 4, 8, and 12/study end
- Clinical Global Impression (CGI) - screening, baseline, and weeks 1, 2, 4, 8, and 12/study end
- Global Assessment Scale (GAS) - screening, baseline, and weeks 1, 2, 4, 8, and 12/study end
- Tolerability:
- Efficacy:
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| Complete list of historical versions of study NCT00194038 on ClinicalTrials.gov Archive Site |
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| Aripiprazole in Late Life Bipolar Disorder |
| Aripiprazole in Late Life Bipolar Disorder |
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). |
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. |
| Phase IV |
| Interventional |
| Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| Bipolar Disorder |
| Drug: Aripiprazole |
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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. |
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| Completed |
| 20 |
| June 2006 |
| June 2006 (final data collection date for primary outcome measure) |
Inclusion Criteria:
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.
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| Both |
| 50 Years and older |
| No |
| Contact information is only displayed when the study is recruiting subjects |
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| |
| NCT00194038 |
| Martha Sajatovic, Case Western Reserve University |
| 10864-01-L0363 |
| University Hospitals of Cleveland |
| Bristol-Myers Squibb |
| Principal Investigator: |
Martha Sajatovic, MD |
Case Western Reserve University School of Medicine |
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| University Hospitals of Cleveland |
| January 2009 |