Treatment of Bipolar Mania in Older Adults

Weill Medical College of Cornell University224 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

224

Conditions

Bipolar Disorder Mania

Interventions

Lithium (LI)DRUG

The starting LI dose will be 150 mg in the morning and evening. The dose of medication will be adjusted to achieve plasma LI level ranges between 0.40 and 0.99 mEq/L (target 0.80 to 0.99 mEq/L).

Divalproex (DV)DRUG

Dosage of DV will be 250 mg in the morning and evening. The dose of medication will be adjusted to achieve plasma DV level ranges between 40 and 99 mcg/mL (target 80 to 99 mcg/ml).

Eligibility

Sex: ALLMin age: 60 Years

Medical Language ↔ Plain English

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

Locations (8)

Precise Research Centers

Flowood, Mississippi, United States

Weill Cornell Medical College

White Plains, New York, United States

Duke University Medical Center

Durham, North Carolina, United States

University Hospitals Case Medical Center

Cleveland, Ohio, United States

Outcomes

Primary Outcomes

Sedation Score

The Sedation Item score of the UKU (Norwegian for Committee of Clinical Investigations) Side Effect Rating Scale. A higher value indicates greater severity. Range is 0-3 (not present, mild, moderate, or severe).

Time frame: Day 4, Day 9, Day 15, and then Weekly from Week 3 to Week 9

Young Mania Rating Scale (YMRS) Scores

The Young Mania Rating Scale is an eleven item interviewer-rated instrument. Four items are scored 0-8, the others 0-4. The total score therefore ranges from 0-60, with higher values reflecting greater severity.

Time frame: Day 4, Day 9, Day 15, and then Weekly from Week 3 to Week 9

Data from ClinicalTrials.gov

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