A Comparison of Two Standard Therapies in the Management of Dementia With Agitation - NCT00208819-30329 (Clinical Trial 130288)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy130288.aspx
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| City: |
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Atlanta |
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State:
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GA |
| Zip Code: |
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30329 |
| Conditions: |
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Senile Dementia, Alzheimer Type - Dementia, Alzheimer Type - Alzheimer Disease - Dementia |
| Purpose: |
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The purpose of this study is to determine whether an antipsychotic medication alone or an
antipsychotic medication in combination with divalproex is the most effective and safest way
to treat agitation in elderly patients with dementia.
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| Study summary: |
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Previous researchers have attempted to establish a “target dose” for antipsychotic
medications (such as risperidone, quetiapine, or olanzapine) in treating symptoms of
agitation in dementia. They have tried to identify the dose with the best risk-benefit
ratio for patients considering the significant side effects the medications can cause.
Patients taking the doses identified respond only partially and continue to experience some
symptoms of agitation, however. One study showed that in patients whose agitation symptoms
were not adequately controlled by the target dose of an antipsychotic medication alone, the
addition of divalproex further improved behavior in 72% of patients.
The goal of this study is to compare two standard therapies for the management of agitation
symptoms in dementia patients. Subjects in this study will include patients who are
admitted to the Wesley Woods Inpatient service for the treatment for dementia complicated by
behavioral symptoms. After a patient reaches the target dose of risperidone (up to 1.5
mg/day), quetiapine (up to 175 mg/day), or olanzapine (up to 7.5 mg/day) and agitation
symptoms are still not adequately managed, he or she will be randomized to one of two
groups. Group 1 participants will continue to receive increasing doses of antipsychotic
medication until symptoms are controlled or he or she is unable to tolerate the dose. Group
2 participants will continue to receive the target dose of antipsychotic medication and also
receive increasing doses of divalproex until symptoms are controlled or he or she is unable
to tolerate the dose. Patients will be evaluated at 4 time points during hospitalization.
Patients will be evaluated using scales that measure changes in cognition, function, and
behavior. Laboratory and ECG results, and scales testing for movement disorders will be
done to monitor safety. The family will then be contacted about 3 months the patient’s
hospitalization to assess current treatment status, residential status, and health status. |
| Criteria: |
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Inclusion Criteria:
- inpatients admitted to Wesley Woods Inpatient service for Dementia with psychosis and
agitation; taking risperidone (up to 1.5 mg/day), quetiapine (up to 175 mg/day), or
olanzapine (up to 7.5 mg/day)
Exclusion Criteria:
- prior sensitivity to risperidone, quetiapine, olanzapine or divalproex |
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| Study is available at: |
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Wesley Woods Geriatric Hospital
Atlanta, GA 30329
United States
Primary Contact:
R. D. Jewart, PhD
Email: rjewart@emory.edu
Phone: 404-728-6414
Secondary Contact:
R. D. Jewart, PhD
Email: rjewart@emory.edu
Phone: 404-728-6414 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 15, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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