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| Descriptive Information Fields | |||||
| Brief Title † | Treatment of Bipolar Mania in Older Adults | ||||
| Official Title † | 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. |
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| 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. |
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| Study Phase | Phase IV | ||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study | ||||
| Primary Outcome Measure † | 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 ] |
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| Secondary Outcome Measure † | |||||
| Condition † | Bipolar Disorder Mania |
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| Intervention † | Drug: Lithium (LI) Drug: Divalproex (DV) |
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| MEDLINE PMIDs | |||||
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| Recruitment Information Fields | |||||
| Recruitment Status † | Recruiting | ||||
| Enrollment † | 258 | ||||
| Start Date † | November 2005 | ||||
| Completion Date | February 2010 | ||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 60 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† |
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| Location Countries † | United States, Canada | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00254488 | ||||
| Organization ID | U01 MH 68844-01A2 | ||||
| Secondary IDs †† | DATR A4-GPX | ||||
| Study Sponsor † | National Institute of Mental Health (NIMH) | ||||
| Collaborators †† | |||||
| Investigators † |
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| Information Provided By | National Institute of Mental Health (NIMH) | ||||
| Verification Date | August 2008 | ||||
| First Received Date † | November 14, 2005 | ||||
| Last Updated Date | August 26, 2008 | ||||
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