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

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ClinicalTrials.gov Identifier: NCT00254488
Recruitment Status : Completed
First Posted : November 16, 2005
Results First Posted : August 14, 2018
Last Update Posted : September 25, 2018
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Weill Medical College of Cornell University

Tracking Information
First Submitted Date  ICMJE November 14, 2005
First Posted Date  ICMJE November 16, 2005
Results First Submitted Date  ICMJE July 19, 2018
Results First Posted Date  ICMJE August 14, 2018
Last Update Posted Date September 25, 2018
Study Start Date  ICMJE November 2005
Actual Primary Completion Date August 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 19, 2018)
  • 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).
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: November 14, 2005)
  • Side effects such as sedation, tremor, GI complaints, weight gain
  • Efficacy measures such as manic symptom scores, life activities functionings, and quality of life
Change History Complete list of historical versions of study NCT00254488 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Treatment of Bipolar Mania in Older Adults
Official Title  ICMJE Acute Pharmacotherapy of Late-Life Mania (GERI-BD)
Brief Summary This study will compare the benefits and side effects of lithium and divalproex in the treatment of older adults with bipolar mania.
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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Bipolar Disorder
  • Mania
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • Experimental: Lithium (LI)
    Participants will receive 9 weeks of treatment with lithium
    Intervention: Drug: Lithium (LI)
  • Experimental: Divalproex (DV)
    Participants will receive 9 weeks of treatment with divalproex
    Intervention: Drug: Divalproex (DV)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 16, 2012)
224
Original Enrollment  ICMJE
 (submitted: November 14, 2005)
258
Actual Study Completion Date  ICMJE August 2011
Actual Primary Completion Date August 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00254488
Other Study ID Numbers  ICMJE U01MH068847( U.S. NIH Grant/Contract )
U01MH068847 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Weill Medical College of Cornell University
Study Sponsor  ICMJE Weill Medical College of Cornell University
Collaborators  ICMJE National Institute of Mental Health (NIMH)
Investigators  ICMJE
Study Chair: Robert Young, MD Cornell University
PRS Account Weill Medical College of Cornell University
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP