Aripiprazole in Late Life Bipolar Disorder - Full Text View

Sponsor:	University Hospitals of Cleveland
Collaborator:	Bristol-Myers Squibb
Information provided by:	University Hospitals of Cleveland
ClinicalTrials.gov Identifier:	NCT00194038

Purpose

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).

Condition	Intervention	Phase
Bipolar Disorder	Drug: Aripiprazole	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Aripiprazole in Late Life Bipolar Disorder

Resource links provided by NLM:

MedlinePlus related topics: Bipolar Disorder Depression

Drug Information available for: Aripiprazole

U.S. FDA Resources

Further study details as provided by University Hospitals of Cleveland:

Primary Outcome Measures:

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 ]

Enrollment:	20
Study Start Date:	April 2004
Study Completion Date:	June 2006
Primary Completion Date:	June 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: Aripiprazole 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.

Arms

Assigned Interventions

1: Experimental

Drug: Aripiprazole

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.

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.

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00194038

Sponsors and Collaborators

University Hospitals of Cleveland

Bristol-Myers Squibb

Investigators

Principal Investigator:

Martha Sajatovic, MD

Case Western Reserve University School of Medicine

More Information

Publications:

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.

Responsible Party:	Case Western Reserve University ( Martha Sajatovic )
Study ID Numbers:	10864-01-L0363
Study First Received:	September 13, 2005
Last Updated:	January 23, 2009
ClinicalTrials.gov Identifier:	NCT00194038 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University Hospitals of Cleveland:

Bipolar Disorder
Geriatric Psychiatry
Aripiprazole

Additional relevant MeSH terms:

Disease
Tranquilizing Agents
Bipolar Disorder
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants
Antipsychotic Agents
Pharmacologic Actions

Affective Disorders, Psychotic
Pathologic Processes
Mental Disorders
Therapeutic Uses
Mood Disorders
Aripiprazole
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 27, 2009