Bipolar Disorder Clinical Trial
Official title:
Acute Pharmacotherapy of Late-Life Mania (GERI-BD)
This study will compare the benefits and side effects of lithium and divalproex in the treatment of older adults with bipolar mania.
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.
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