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
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 |
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.
Status | Completed |
Enrollment | 50 |
Est. completion date | July 2007 |
Est. primary completion date | |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Wesley Woods Geriatric Hospital | Atlanta | Georgia |
Lead Sponsor | Collaborator |
---|---|
Emory University | Abbott |
United States,
Tune L. Management of Noncognitive Symptoms of Dementia. Essentials of Clinical Psychopharmacology, 2nd ed. 2001: 935-948.
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 |
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