Seroquel- Agitation Associated With Dementia
Phase 3
Completed
- Conditions
- Alzheimer's DiseaseVascular Dementia
- Interventions
- Drug: Quetiapine FumarateDrug: Placebo
- Registration Number
- NCT00621647
- Lead Sponsor
- AstraZeneca
- Brief Summary
The purpose of this study is to determine how safe and effective Seroquel (quetiapine fumarate) is compared to placebo (a non-drug tablet) for a period of up to 10 weeks in the treatment of agitation symptoms in nursing home or assisted care residents.
PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 333
Inclusion Criteria
- Subjects must have a diagnosis of dementia compatible with probable or possible Alzheimer's disease (AD)
- Subjects exhibit inappropriate verbal, vocal, or motor activity that requires treatment with an antipsychotic medication in addition to or beyond behavioural modification therapy
- Subject must have a score of at least 14 on the PANSS
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Exclusion Criteria
- Current or past symptoms for schizophrenia, schizoaffective disorder, or bipolar disorder
- Symptoms of agitation that are caused by another general medical condition or direct physiological effects of a substance
- Failure to respond on 2 occasions to an adequate regimen of atypical antipsychotic medications for the treatment of agitation and/or aggression
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description 1 Quetiapine Fumarate 1st fixed dose 2 Quetiapine Fumarate 2nd fixed dose 3 Placebo Placebo
- Primary Outcome Measures
Name Time Method To assess the efficacy of 2 fixed doses of quetiapine compared with placebo Twice weekly
- Secondary Outcome Measures
Name Time Method To assess the efficacy of quetiapine compared with placebo Twice weekly