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

This study has been completed.
Sponsor:
Collaborator:
Abbott
Information provided by (Responsible Party):
Larry Tune, MD, Emory University
ClinicalTrials.gov Identifier:
NCT00208819
First received: September 13, 2005
Last updated: November 12, 2013
Last verified: November 2013
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Georgia
Wesley Woods Geriatric Hospital
Atlanta, Georgia, United States, 30329
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.

Responsible Party: Larry Tune, MD, Principal Investigator, Emory University
ClinicalTrials.gov Identifier: NCT00208819     History of Changes
Other Study ID Numbers: 0673-2003
Study First Received: September 13, 2005
Last Updated: November 12, 2013
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Psychomotor Agitation
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Psychomotor Disorders
Neurobehavioral Manifestations
Signs and Symptoms
Valproic Acid
Risperidone
Quetiapine
Olanzapine
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
GABA Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Antimanic Agents
Tranquilizing Agents

ClinicalTrials.gov processed this record on July 22, 2014