Aripiprazole in Late Life Bipolar Disorder

Condition(s) targeted: Bipolar Disorder

Intervention: Aripiprazole (Drug)

Phase: Phase 4

Status: Completed

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

Primary outcome:

Tolerability:

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

Efficacy:

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

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.

Minimum age: 50 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

Starting date: April 2004
Ending date: June 2006
Last updated: February 12, 2008