Treatment of Bipolar Mania in Older Adults (GERI-BD)

Weill Cornell Medicine (WCM)

Status and phase: Completed; Phase 4

Conditions: Bipolar Disorder; Mania

Treatments: Drug: Lithium (LI); Drug: Divalproex (DV)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00254488

U01MH068847 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

This study will compare the benefits and side effects of lithium and divalproex in the treatment of older adults with bipolar mania.

Full description

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.

Enrollment: 224 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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224 participants in 2 patient groups

Lithium (LI)

Experimental group

Description:

Participants will receive 9 weeks of treatment with lithium

Treatment:

Drug: Lithium (LI)

Divalproex (DV)

Experimental group

Description:

Participants will receive 9 weeks of treatment with divalproex

Treatment:

Drug: Divalproex (DV)