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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00254488
Recruitment Status : Completed
First Posted : November 16, 2005
Results First Posted : August 14, 2018
Last Update Posted : September 25, 2018
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Weill Medical College of Cornell University

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

Condition or disease Intervention/treatment Phase
Bipolar Disorder Mania Drug: Lithium (LI) Drug: Divalproex (DV) Phase 4

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 224 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Acute Pharmacotherapy of Late-Life Mania (GERI-BD)
Study Start Date : November 2005
Actual Primary Completion Date : August 2011
Actual Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Lithium (LI)
Participants will receive 9 weeks of treatment with lithium
Drug: Lithium (LI)
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).
Other Name: Depakote

Experimental: Divalproex (DV)
Participants will receive 9 weeks of treatment with divalproex
Drug: Divalproex (DV)
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).
Other Name: Valproate

Primary Outcome Measures :
  1. Sedation Score [ Time Frame: Day 4, Day 9, Day 15, and then Weekly from Week 3 to Week 9 ]
    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).

  2. Young Mania Rating Scale (YMRS) Scores [ Time Frame: Day 4, Day 9, Day 15, and then Weekly from Week 3 to Week 9 ]
    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00254488

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United States, Mississippi
Precise Research Centers
Flowood, Mississippi, United States, 39232
United States, New York
Weill Cornell Medical College
White Plains, New York, United States, 10605
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Ohio
University Hospitals Case Medical Center
Cleveland, Ohio, United States, 44106
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
Canada, Ontario
Centre for Addiction and Mental Health
Toronto, Ontario, Canada, M6J1H4
Sponsors and Collaborators
Weill Medical College of Cornell University
National Institute of Mental Health (NIMH)
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Study Chair: Robert Young, MD Cornell University
Publications of Results:

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Weill Medical College of Cornell University Identifier: NCT00254488    
Other Study ID Numbers: U01MH068847 ( U.S. NIH Grant/Contract )
U01MH068847 ( U.S. NIH Grant/Contract )
First Posted: November 16, 2005    Key Record Dates
Results First Posted: August 14, 2018
Last Update Posted: September 25, 2018
Last Verified: August 2018
Additional relevant MeSH terms:
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Bipolar Disorder
Bipolar and Related Disorders
Mental Disorders
Valproic Acid
Psychotropic Drugs
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
GABA Agents
Neurotransmitter Agents