- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00621647
Seroquel- Agitation Associated With Dementia
A Multicenter, Double-Blind, Randomized, Comparison of the Efficacy and Safety of Quetiapine Fumarate (SEROQUEL) and Placebo in the Treatment of Agitation Associated With Dementia.
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 3
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
1st fixed dose
|
Other Names:
|
Experimental: 2
2nd fixed dose
|
Other Names:
|
Sham Comparator: 3
Placebo
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To assess the efficacy of 2 fixed doses of quetiapine compared with placebo
Time Frame: Twice weekly
|
Twice weekly
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To assess the efficacy of quetiapine compared with placebo
Time Frame: Twice weekly
|
Twice weekly
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Cardiovascular Diseases
- Vascular Diseases
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Neurologic Manifestations
- Neurobehavioral Manifestations
- Neurocognitive Disorders
- Neurodegenerative Diseases
- Dyskinesias
- Psychomotor Disorders
- Tauopathies
- Intracranial Arterial Diseases
- Intracranial Arteriosclerosis
- Leukoencephalopathies
- Psychomotor Agitation
- Dementia
- Alzheimer Disease
- Dementia, Vascular
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Antipsychotic Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Antidepressive Agents
- Quetiapine Fumarate
Other Study ID Numbers
- 5077US/0046
- D1446L00002
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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