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

Alzheimer Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00208819
• Other study ID #: 0673-2003
• Status: Completed
• Phase: Phase 4
• First received: September 13, 2005
• Last updated: November 12, 2013
• Start date: September 2003
• Est. completion date: July 2007

Study information

• Verified date: November 2013
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alzheimer Disease
• Dementia
• Dementia, Alzheimer Type
• Senile Dementia, Alzheimer Type

Intervention

Drug:
• risperidone

• quetiapine

• olanzapine

• divalproex

Locations

Country	Name	City	State
United States	Wesley Woods Geriatric Hospital	Atlanta	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Emory University	Abbott

Country where clinical trial is conducted

United States, 

References & Publications (1)

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

Outcome

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