Treatment of Geriatric Bipolar Mood Disorders: A Pilot Study
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Bipolar Disorder
- Sponsor
- University of Pittsburgh
- Enrollment
- 60
- Locations
- 2
- Primary Endpoint
- 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
- Status
- Completed
- Last Updated
- 20 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
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 Outcomes
- Measures of affective symptoms, functional status, side effects, and cognition tracked over acute, continuation, and maintenance phases of treatment.