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| Sponsor: | Emory University |
|---|---|
| Collaborator: |
Abbott |
| Information provided by: | Emory University |
| ClinicalTrials.gov Identifier: | NCT00208819 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Senile Dementia, Alzheimer Type Dementia, Alzheimer Type Alzheimer Disease Dementia |
Drug: risperidone Drug: quetiapine Drug: olanzapine Drug: divalproex |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Randomized Comparison of Monotherapy (Risperidone, Quetiapine, or Olanzapine) Versus Combination Therapy (Risperidone, Quetiapine, or Olanzapine + Divalproex)in the Management of Dementia With Agitation: A Pilot Comparison of Two Standard Therapies |
| Estimated Enrollment: | 50 |
| Study Start Date: | September 2003 |
| Estimated Study Completion Date: | July 2007 |
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.
Eligibility| Ages Eligible for Study: | 65 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: R. D. Jewart, PhD | 404-728-6414 | rjewart@emory.edu |
| Contact: J. D. Rosenberg | 404-728-4784 | jdrose4@emory.edu |
| United States, Georgia | |
| Wesley Woods Geriatric Hospital | Recruiting |
| Atlanta, Georgia, United States, 30329 | |
| Contact: R. D. Jewart, PhD 404-728-6414 rjewart@emory.edu | |
| Contact: Julie D Rosenberg 404-728-4784 jdrose4@emory.edu | |
| Principal Investigator: Larry E. Tune, MD, MAS | |
| Principal Investigator: | Larry E. Tune, MD, MAS | Emory University |
More Information
| Study ID Numbers: | 673-2003 |
| Study First Received: | September 13, 2005 |
| Last Updated: | April 16, 2007 |
| ClinicalTrials.gov Identifier: | NCT00208819 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Alzheimer's Disease Geriatric Dementia |
Agitation Behavioral Disturbances Psychosis |
|
Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Olanzapine Psychotropic Drugs Antiemetics Neurodegenerative Diseases Brain Diseases Valproic Acid Serotonin Antagonists Mental Disorders Therapeutic Uses Dementia Tranquilizing Agents |
Nervous System Diseases Alzheimer Disease Gastrointestinal Agents Risperidone Central Nervous System Diseases Central Nervous System Depressants Dopamine Antagonists Enzyme Inhibitors Antipsychotic Agents Antimanic Agents Serotonin Uptake Inhibitors Pharmacologic Actions Quetiapine Serotonin Agents Delirium, Dementia, Amnestic, Cognitive Disorders |