Official Title: “Treatment of Geriatric Bipolar Mood Disorders: A Pilot Study”

The purpose of this study is to collect pilot data on the feasibility of recruiting, eliciting informed consent, assessing, treating, and following patients aged 60 and older with bipolar mood disorders.

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study

Study specific aims are: - to establish a recruitment, referral, and collaborative network for elderly bipolar patients, in collaboration with the NIMH funded STEP-BD - to establish an outpatient treatment clinic at the Bellefield Towers site of the NIMH funded Intervention Research Center for Late Life Mood Disorders - to implement standardized care pathways compatible with STEP-BD treatment algorithms for mood stabilizing pharmacotherapy. - to document short- and long-term treatment response with respect to affective symptoms, sleep, general life functioning, cognition, treatment-emergent side effects - to establish the clinical infrastructure necessary for randomized controlled clinical trials and for clinical research training in bipolar mood disorders of late-life.

Intervention(s) in this Clinical Trial

• Drug: lithium carbonate
• Drug: Depakote-ER
• Drug: risperidone
• Drug: olanzapine
• Drug: paroxetine
• Drug: bupropion
• Drug: lamotrigine
• Drug: venlafaxine
• Drug: tranylcypromine
• Drug: mirtazapine

Primary Measures

• The percent of subjects remitting from their index affective episode, the time to remission, the percent of partially and non-remitting patients, the incidence of relapse during continuation treatment, and of recurrence during maintenance treatment

Secondary Measures

• Measures of affective symptoms, functional status, side effects, and cognition tracked over acute, continuation, and maintenance phases of treatment.

Inclusion Criteria:

• DSM-IV diagnosis of Bipolar Disorder
• Folstein Mini-Mental Status Exam score of 18 or higher

Exclusion Criteria:

• Medical condition that precludes the use of both lithium and depakote
• If mood disturbance is deemed an organic mood disorder (i.e., iatrogenic, secondary to medication)
• If refuse to designate someone who the study staff can contact about bipolar symptoms, concerns about the subject's health, in an emergency, and/or inability to reach the subject.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 60 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: University of Pittsburgh

Overall Clinical Trial Officials and Contacts

Charles F Reynolds III, MD Principal Investigator University of Pittsburgh  

Information obtained from ClinicalTrials.gov on November 19, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00177567

Study ID Number: 010614

ClinicalTrials.gov Identifier: NCT00177567

Health Authority: United States: Institutional Review Board

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