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Aripiprazole in Late Life Bipolar Disorder

Information source: University Hospital Case Medical Center
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Bipolar Disorder

Intervention: Aripiprazole (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: University Hospital Case Medical Center

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).

Clinical Details

Official title: Aripiprazole in Late Life Bipolar Disorder

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Blood pressure and pulse


Abnormal Involuntary Movement Scale (AIMS)

Barnes Akathisia Scale (BAS)

Simpson Angus Neurological Rating Scale (SAS)

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)

Global Assessment Scale (GAS)

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.


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;


- Receiving carbamazepine.

Locations and Contacts

Additional Information

Starting date: April 2004
Last updated: December 16, 2014

Page last updated: August 20, 2015

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