View Clinical Trial (Medical Research Study)
Acute Pharmacotherapy of Late-Life Mania (GERI-BD)
| City: |
|
Houston |
| State: |
|
Texas |
| Zip Code: |
|
77030 |
| Conditions: |
|
Bipolar Disorder - Mania |
| Purpose: |
|
This study will compare the benefits and side effects of lithium and divalproex in the
treatment of older adults with bipolar mania.
|
| Study Summary: |
|
This is the first controlled acute treatment study of bipolar disorder in adults 60 years or
older with current DSM-IV manic, mixed, or hypomanic episodes. The number of older adults
with severe and disabling bipolar disorder is increasing, and information to guide the
management of the treatment of the disease is lacking in this population. Guidelines for
treatment of younger people with bipolar disorder cannot be used for older people, and there
are no safety and efficacy data upon which to base initial treatment decisions for older
patients with bipolar mania. Mood stabilizers (lithium and divalproex) are the first-line
treatment for bipolar disorder. However, in aged patients physiological changes and
comorbid diseases may increase vulnerability to side effects and limit the benefits of the
medications.
This double-blind study will compare the benefits and side-effects of 9 weeks of treatment
with lithium and divalproex in people with bipolar mania. Participants, who may be treated
during inpatient hospitalization or as outpatients, will be randomly assigned to receive
either lithium or divalproex. During the first 3 weeks of treatment careful titration of
lithium and divalproex will be done to reach dose ranges. All other psychotropic medications
will be discontinued. Behavioral interventions and/or lorazepam may be added, if
necessary. After the first 3 weeks, if symptoms do not improve, risperidone will be added
to be taken everyday with the study medication.
|
| Criteria: |
|
Inclusion Criteria:
- Diagnosis of DSM-IV Bipolar Disorder, Type I: current manic, mixed, or hypomanic
episodes
Exclusion Criteria:
- Rapid cycling bipolar disorder
- History of substance abuse or dependence within last 3 months
- Diagnosis of schizophrenia or other chronic psychotic conditions
- Acute or unstable medical illness
- Documented intolerance to Lithium, Depakote, Risperidone, or Lorazepam
- Dementia
- Inability to communicate in English
|
| NCT ID: |
|
NCT00254488 |
| Primary Contact: |
|
Study Chair
Robert Young, MD
Cornell University
Laurie Davan
Phone: 914-682-9100 ext. 2570
Email: lad9011@med.cornell.edu
|
| Backup Contact: |
|
N/A |
| Location Contact: |
|
Houston, Texas 77030
United States
Barbara Kertz
Phone: 713-794-8815
Email: bkertz@bcm.tmc.edu
Site Status: Recruiting |
| Data Source: |
|
ClinicalTrials.gov |
| Date Processed: |
|
May 24, 2013 |
| Modifications to this listing: |
|
Only selected fields are shown, please use the link
below to view all information about this clinical trial. |
|
Click to view Full Listing
|