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
|Condition or disease||Intervention/treatment||Phase|
|Bipolar Disorder Mania||Drug: Lithium (LI) Drug: Divalproex (DV)||Phase 4|
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 (Clinical Trial)|
|Actual Enrollment :||224 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|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|
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
- 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.
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 ClinicalTrials.gov identifier (NCT number): NCT00254488
|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|
|Centre for Addiction and Mental Health|
|Toronto, Ontario, Canada, M6J1H4|
|Study Chair:||Robert Young, MD||Cornell University|