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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

September 13, 2005
November 12, 2013
September 2003
Not Provided
  • 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
  • Pittsburgh Aggitation 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
Complete list of historical versions of study NCT00208819 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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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

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Senile Dementia, Alzheimer Type
  • Dementia, Alzheimer Type
  • Alzheimer Disease
  • Dementia
  • Drug: risperidone
  • Drug: quetiapine
  • Drug: olanzapine
  • Drug: divalproex
Not Provided
Tune L. Management of Noncognitive Symptoms of Dementia. Essentials of Clinical Psychopharmacology, 2nd ed. 2001: 935-948.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
July 2007
Not Provided

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
Both
65 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00208819
0673-2003
Not Provided
Larry Tune, MD, Emory University
Emory University
Abbott
Principal Investigator: Larry E. Tune, MD, MAS Emory University
Emory University
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP