Seroquel- Agitation Associated With Dementia
This study has been completed.
Sponsor:
AstraZeneca
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00621647
First received: February 6, 2008
Last updated: March 24, 2009
Last verified: March 2009
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Alzheimer's Disease Vascular Dementia |
Drug: Quetiapine Fumarate Drug: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Factorial Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | 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. |
Resource links provided by NLM:
Further study details as provided by AstraZeneca:
Primary Outcome Measures:
- To assess the efficacy of 2 fixed doses of quetiapine compared with placebo [ Time Frame: Twice weekly ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- To assess the efficacy of quetiapine compared with placebo [ Time Frame: Twice weekly ] [ Designated as safety issue: No ]
| Enrollment: | 333 |
| Study Start Date: | September 2002 |
| Study Completion Date: | November 2003 |
| Primary Completion Date: | November 2003 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
1st fixed dose
|
Drug: Quetiapine Fumarate
Other Name: Seroquel
|
|
Experimental: 2
2nd fixed dose
|
Drug: Quetiapine Fumarate |
|
Sham Comparator: 3
Placebo
|
Drug: Placebo |
Eligibility| Ages Eligible for Study: | 55 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
No Contacts or Locations Provided
More Information
No publications provided
| Responsible Party: | Hans Eriksson / Medical Science Director, AstraZeneca |
| ClinicalTrials.gov Identifier: | NCT00621647 History of Changes |
| Other Study ID Numbers: | 5077US/0046, D1446L00002 |
| Study First Received: | February 6, 2008 |
| Last Updated: | March 24, 2009 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by AstraZeneca:
|
Seroquel dementia agitation symptoms |
Alzheimer's disease vascular dementia quetiapine fumarate |
Additional relevant MeSH terms:
|
Alzheimer Disease Dementia Dementia, Vascular Psychomotor Agitation Brain Diseases Central Nervous System Diseases Nervous System Diseases Tauopathies Neurodegenerative Diseases Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Cerebrovascular Disorders Intracranial Arteriosclerosis Intracranial Arterial Diseases Leukoencephalopathies |
Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Cardiovascular Diseases Dyskinesias Neurologic Manifestations Psychomotor Disorders Neurobehavioral Manifestations Signs and Symptoms Quetiapine Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013