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Treatment of Bipolar Mania in Older Adults
This study is currently recruiting participants.
Verified by National Institute of Mental Health (NIMH), August 2008
Sponsored by: National Institute of Mental Health (NIMH)
Information provided by: National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier: NCT00254488
  Purpose

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


Condition Intervention Phase
Bipolar Disorder
Mania
Drug: Lithium (LI)
Drug: Divalproex (DV)
Phase IV

MedlinePlus related topics: Bipolar Disorder
Drug Information available for: Divalproex sodium Valproate Sodium Valproic acid Lithium carbonate Lithium citrate
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Acute Pharmacotherapy of Late-Life Mania (GERI-BD)

Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:
  • Side effects, such as sedation, tremor, GI complaints, and weight gain [ Time Frame: Measured over 9 weeks of treatment ] [ Designated as safety issue: No ]
  • Efficacy measures such as manic symptom scores, life activities functioning, and quality of life [ Time Frame: Measured at baseline and Week 9 ] [ Designated as safety issue: No ]

Estimated Enrollment: 258
Study Start Date: November 2005
Estimated Study Completion Date: February 2010
Estimated Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
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).
2: Experimental
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).

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.

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00254488

Contacts
Contact: Laurie Davan 914-682-9100 ext 2570 lad9011@med.cornell.edu

Locations
United States, Mississippi
Precise Research Centers Recruiting
Flowood, Mississippi, United States, 39232
Contact: Taheera Hoskins     601-420-5810     thoskins@precise-research.com    
Principal Investigator: Joseph Kwentus, MD            
United States, New York
Weill Cornell Medical College Recruiting
White Plains, New York, United States, 10605
Contact: Laurie Davan     914-682-9100 ext 2570     lad9011@med.cornell.edu    
Principal Investigator: Robert Young, MD            
Sub-Investigator: Herbert Schulberg, PhD            
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Mike Mani     919-681-8362     mani0002@mc.duke.edu    
Principal Investigator: John Beyer, MD            
United States, Ohio
University Hospitals Case Medical Center Recruiting
Cleveland, Ohio, United States, 44106
Contact: Kristin Cassidy     216-844-2834     Kristin.Cassidy@uhhospitals.org    
Principal Investigator: Martha Sajatovic, MD            
United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Marna Barrett     215-746-6414     msb@mail.med.upenn.edu    
Principal Investigator: Laszlo Gyulai, MD            
University of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Nancy McLaughlin     412-246-6008     mclaughlinn@upmc.edu    
Principal Investigator: Benoit Mulsant, MD            
Sub-Investigator: Ariel Gildengers, MD            
United States, Texas
Baylor College of Medicine Recruiting
Houston, Texas, United States, 77030
Contact: Barbara Kertz     713-794-8815     bkertz@bcm.tmc.edu    
Principal Investigator: Mark Kunik, MD            
Canada, Ontario
Centre for Addiction and Mental Health Recruiting
Toronto, Ontario, Canada, M6J1H4
Contact: Dielle Miranda     416-535-8501 ext 3120     dielle_miranda@camh.net    
Principal Investigator: Bruce Pollock, MD, PhD            
Sponsors and Collaborators
Investigators
Study Chair: Robert Young, MD Cornell University
  More Information

Responsible Party: Weill Cornell Medical College ( Robert Young, MD/Principal Investigator )
Study ID Numbers: U01 MH 68844-01A2, DATR A4-GPX
Study First Received: November 14, 2005
Last Updated: August 26, 2008
ClinicalTrials.gov Identifier: NCT00254488  
Health Authority: United States: Federal Government

Study placed in the following topic categories:
Affective Disorders, Psychotic
Mental Disorders
Bipolar Disorder
Mood Disorders
Lithium Carbonate
Psychotic Disorders
Valproic Acid
Lithium

ClinicalTrials.gov processed this record on January 30, 2009