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

August 27, 2018 updated by: Weill Medical College of Cornell University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

224

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M6J1H4
        • Centre for Addiction and Mental Health
  • United States
    • Mississippi
      • Flowood, Mississippi, United States, 39232
        • Precise Research Centers
    • New York
      • White Plains, New York, United States, 10605
        • Weill Cornell Medical College
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • University Hospitals Case Medical Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh
    • Texas
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • Valproate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Day 4, Day 9, Day 15, and then Weekly from Week 3 to Week 9
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.
Day 4, Day 9, Day 15, and then Weekly from Week 3 to Week 9

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Weill Medical College of Cornell University

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Study Chair: Robert Young, MD, Cornell University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2005

Primary Completion (Actual)

August 1, 2011

Study Completion (Actual)

August 1, 2011

Study Registration Dates

First Submitted

November 14, 2005

First Submitted That Met QC Criteria

November 14, 2005

First Posted (Estimate)

November 16, 2005

Study Record Updates

Last Update Posted (Actual)

September 25, 2018

Last Update Submitted That Met QC Criteria

August 27, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • U01MH068847 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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