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A Comparison of Two Standard Therapies in the Management of Dementia With Agitation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00208819
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : November 13, 2013
Information provided by (Responsible Party):
Larry Tune, MD, Emory University

Brief Summary:
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 or disease Intervention/treatment Phase
Senile Dementia, Alzheimer Type Dementia, Alzheimer Type Alzheimer Disease Dementia Drug: risperidone Drug: quetiapine Drug: olanzapine Drug: divalproex Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : September 2003
Actual Study Completion Date : July 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dementia

Primary Outcome Measures :
  1. Pittsburgh Agitation Scale (PAS)
  2. DiMarco Rating Scale for Extrapyramidal Symptoms
  3. UKU side effect rating scale:autonomic subscale
  4. Behavioral Activity Rating Scale (BARS)
  5. Visual Analog Scale for Nighttime Sleep and Daytime drowsiness (VAS)
  6. Confusion Assessment Method (CAM)
  7. Mini-Mental State Exam (MMSE)
  8. Cohen-Mansfield Agitation Inventory

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00208819

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United States, Georgia
Wesley Woods Geriatric Hospital
Atlanta, Georgia, United States, 30329
Sponsors and Collaborators
Emory University
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Principal Investigator: Larry E. Tune, MD, MAS Emory University

Tune L. Management of Noncognitive Symptoms of Dementia. Essentials of Clinical Psychopharmacology, 2nd ed. 2001: 935-948.

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Responsible Party: Larry Tune, MD, Principal Investigator, Emory University Identifier: NCT00208819    
Other Study ID Numbers: 0673-2003
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: November 13, 2013
Last Verified: November 2013
Keywords provided by Larry Tune, MD, Emory University:
Alzheimer's Disease
Behavioral Disturbances
Additional relevant MeSH terms:
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Alzheimer Disease
Psychomotor Agitation
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Neurologic Manifestations
Psychomotor Disorders
Neurobehavioral Manifestations
Signs and Symptoms
Quetiapine Fumarate
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents