- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00208819
A Comparison of Two Standard Therapies in the Management of Dementia With Agitation
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
Study Overview
Status
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Locations
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Georgia
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Atlanta, Georgia, United States, 30329
- Wesley Woods Geriatric Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Cohen-Mansfield Agitation Inventory
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Pittsburgh Agitation Scale (PAS)
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DiMarco Rating Scale for Extrapyramidal Symptoms
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UKU side effect rating scale:autonomic subscale
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Behavioral Activity Rating Scale (BARS)
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Visual Analog Scale for Nighttime Sleep and Daytime drowsiness (VAS)
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Confusion Assessment Method (CAM)
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Mini-Mental State Exam (MMSE)
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Larry E. Tune, MD, MAS, Emory University
Publications and helpful links
General Publications
- Tune L. Management of Noncognitive Symptoms of Dementia. Essentials of Clinical Psychopharmacology, 2nd ed. 2001: 935-948.
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neurologic Manifestations
- Neurobehavioral Manifestations
- Neurocognitive Disorders
- Neurodegenerative Diseases
- Dyskinesias
- Psychomotor Disorders
- Tauopathies
- Psychomotor Agitation
- Dementia
- Alzheimer Disease
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Autonomic Agents
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Antiemetics
- Gastrointestinal Agents
- Antipsychotic Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Serotonin Uptake Inhibitors
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Serotonin Agents
- Antidepressive Agents
- Dopamine Agents
- Serotonin Antagonists
- Dopamine Antagonists
- GABA Agents
- Anticonvulsants
- Antimanic Agents
- Olanzapine
- Valproic Acid
- Quetiapine Fumarate
- Risperidone
Other Study ID Numbers
- 0673-2003
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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