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Sponsored by: |
National Institute of Mental Health (NIMH) |
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Information provided by: | National Institute of Mental Health (NIMH) |
ClinicalTrials.gov Identifier: | NCT00254488 |
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 |
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) |
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
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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).
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2: Experimental
Participants will receive 9 weeks of treatment with divalproex
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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).
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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.
Ages Eligible for Study: | 60 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Laurie Davan | 914-682-9100 ext 2570 | lad9011@med.cornell.edu |
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 |
Study Chair: | Robert Young, MD | Cornell University |
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 |
Affective Disorders, Psychotic Mental Disorders Bipolar Disorder Mood Disorders |
Lithium Carbonate Psychotic Disorders Valproic Acid Lithium |