Aripiprazole in Late Life Bipolar Disorder
Information source: University Hospitals of Cleveland
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Bipolar Disorder
Intervention: Aripiprazole (Drug)
Phase: Phase 4
Sponsored by: University Hospitals of Cleveland
Official(s) and/or principal investigator(s):
Martha Sajatovic, MD, Principal Investigator, Affiliation: Case Western Reserve University School of Medicine
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).
Official title: Aripiprazole in Late Life Bipolar Disorder
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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
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.
Minimum age: 50 Years.
Maximum age: N/A.
- 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.
- 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;
- Receiving carbamazepine.
Locations and Contacts
Starting date: April 2004
Ending date: June 2006
Last updated: February 12, 2008