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A Comparison of Two Standard Therapies in the Management of Dementia With Agitation
This study is currently recruiting participants.
Verified by Emory University, April 2007
First Received: September 13, 2005   Last Updated: April 16, 2007   History of Changes
Sponsors and Collaborators: Emory University
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

Resource links provided by NLM:


Further study details as provided by 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
Estimated 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.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00208819

Contacts
Contact: R. D. Jewart, PhD 404-728-6414 rjewart@emory.edu
Contact: J. D. Rosenberg 404-728-4784 jdrose4@emory.edu

Locations
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            
Sponsors and Collaborators
Emory University
Abbott
Investigators
Principal Investigator: Larry E. Tune, MD, MAS Emory University
  More Information

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

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

Keywords provided by Emory University:
Alzheimer's Disease
Geriatric
Dementia
Agitation
Behavioral Disturbances
Psychosis

Study placed in the following topic categories:
Neurotransmitter Agents
Olanzapine
Psychotropic Drugs
Antiemetics
Psychomotor Agitation
Neurodegenerative Diseases
Brain Diseases
Dopamine
Mental Disorders
Psychotic Disorders
Dementia
Delirium
Tranquilizing Agents
Alzheimer Disease
Risperidone
Central Nervous System Diseases
Central Nervous System Depressants
Antipsychotic Agents
Serotonin Uptake Inhibitors
Cognition Disorders
Serotonin
Quetiapine
Delirium, Dementia, Amnestic, Cognitive Disorders
Dopamine Agents
Peripheral Nervous System Agents

Additional relevant MeSH terms:
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Olanzapine
Psychotropic Drugs
Antiemetics
Neurodegenerative Diseases
Brain Diseases
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
Antipsychotic Agents
Serotonin Uptake Inhibitors
Pharmacologic Actions
Quetiapine
Delirium, Dementia, Amnestic, Cognitive Disorders
Serotonin Agents
Autonomic Agents
Dopamine Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on July 06, 2009