Treatment of Geriatric Bipolar Mood Disorders: A Pilot Study

Study 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.

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

Conditions
-----------------
Bipolar Disorder

Intervention / Treatment
-----------------
* Drug: lithium carbonate
* Drug: Depakote-ER
* Drug: risperidone
* Drug: olanzapine
* Drug: paroxetine
* Drug: bupropion
* Drug: lamotrigine
* Drug: venlafaxine
* Drug: tranylcypromine
* Drug: mirtazapine


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: lithium carbonate|nan|
|Drug: Depakote-ER|nan|
|Drug: risperidone|nan|
|Drug: olanzapine|nan|
|Drug: paroxetine|nan|
|Drug: bupropion|nan|
|Drug: lamotrigine|nan|
|Drug: venlafaxine|nan|
|Drug: tranylcypromine|nan|
|Drug: mirtazapine|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measures of affective symptoms, functional status, side effects, and cognition tracked over acute, continuation, and maintenance phases of treatment. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bipolar Disorder, Manic Depression, Elderly, Late-Life