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

This study has been completed.
Information provided by (Responsible Party):
Larry Tune, MD, Emory University Identifier:
First received: September 13, 2005
Last updated: November 12, 2013
Last verified: November 2013
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 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Larry Tune, MD, Emory University:

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

Estimated Enrollment: 50
Study Start Date: September 2003
Study Completion Date: July 2007
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.


Ages Eligible for Study:   65 Years and older   (Adult, Senior)
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
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Please refer to this study by its identifier: NCT00208819

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

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

Responsible Party: Larry Tune, MD, Principal Investigator, Emory University Identifier: NCT00208819     History of Changes
Other Study ID Numbers: 0673-2003
Study First Received: September 13, 2005
Last Updated: November 12, 2013

Keywords provided by Larry Tune, MD, Emory University:
Alzheimer's Disease
Behavioral Disturbances

Additional relevant MeSH terms:
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
Antiemetics processed this record on August 17, 2017