Seroquel- Agitation Associated With Dementia

This study has been completed.

Sponsor:

Information provided by:

AstraZeneca

ClinicalTrials.gov Identifier:

NCT00621647

First received: February 6, 2008

Last updated: March 24, 2009

Last verified: March 2009

History of Changes

Tracking Information
First Received Date ^ICMJE	February 6, 2008
Last Updated Date	March 24, 2009
Start Date ^ICMJE	September 2002
Primary Completion Date	November 2003 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: February 11, 2008)	To assess the efficacy of 2 fixed doses of quetiapine compared with placebo [ Time Frame: Twice weekly ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00621647 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: February 11, 2008)	To assess the efficacy of quetiapine compared with placebo [ Time Frame: Twice weekly ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Seroquel- Agitation Associated With Dementia
Official Title ^ICMJE	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.
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 Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Factorial Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
Condition ^ICMJE	Alzheimer's Disease Vascular Dementia
Intervention ^ICMJE	Drug: Quetiapine Fumarate Other Name: Seroquel Drug: Quetiapine Fumarate Drug: Placebo
Study Arm (s)	Experimental: 1 1st fixed dose Intervention: Drug: Quetiapine Fumarate Experimental: 2 2nd fixed dose Intervention: Drug: Quetiapine Fumarate Sham Comparator: 3 Placebo Intervention: Drug: Placebo
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	333
Completion Date	November 2003
Primary Completion Date	November 2003 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	55 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT00621647
Other Study ID Numbers ^ICMJE	5077US/0046, D1446L00002
Has Data Monitoring Committee	No
Responsible Party	Hans Eriksson / Medical Science Director, AstraZeneca
Study Sponsor ^ICMJE	AstraZeneca
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	AstraZeneca
Verification Date	March 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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