Aripiprazole in Late Life Bipolar Disorder

Phase 4CompletedNCT00194038

University Hospitals Cleveland Medical Center20 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Bipolar Disorder

Interventions

AripiprazoleDRUG

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.

Eligibility

Sex: ALLMin age: 50 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Blood pressure and pulse

Time frame: 12 weeks

Weight

Time frame: 12 weeks

Abnormal Involuntary Movement Scale (AIMS)

Time frame: 12 weeks

Barnes Akathisia Scale (BAS)

Time frame: 12 weeks

Simpson Angus Neurological Rating Scale (SAS)

Time frame: 12 weeks

Basic serum chemistry - screening and 12/study end

Time frame: 12 weeks

Complete blood count (CBC) with differential - screening and 12/study end

Time frame: 12 weeks

Electrocardiogram - screening and 12/study end

Time frame: 12 weeks

Young Mania Rating Scale (YMRS) - screening, baseline, and weeks 1, 2, 4, 8, and 12/study end

Time frame: 12 weeks

Hamilton Depression Rating Scale (HAM-D) - screening, baseline, and weeks 1, 2, 4, 8, and 12/study end

Time frame: 12 weeks

Clinical Global Impression (CGI)

Time frame: 12 weeks

Global Assessment Scale (GAS)

Time frame: 12 weeks

Data from ClinicalTrials.gov

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