Bipolar Disorder
Conditions
Keywords
Bipolar Disorder, Manic Depression, Elderly, Late-Life
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.
Interventions
DRUGlithium carbonate
DRUGDepakote-ER
DRUGrisperidone
DRUGolanzapine
DRUGparoxetine
DRUGbupropion
DRUGlamotrigine
DRUGvenlafaxine
DRUGtranylcypromine
DRUGmirtazapine
Sponsors
University of Pittsburgh
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Measures of affective symptoms, functional status, side effects, and cognition tracked over acute, continuation, and maintenance phases of treatment. | — |
Countries
United States
Outcome results
None listed