Seroquel- Agitation Associated With Dementia - Tabular View

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

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
Study Phase	Phase III
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Factorial Assignment, Safety/Efficacy Study
Condition ^ICMJE	Alzheimer's Disease Vascular Dementia
Intervention ^ICMJE	Drug: Quetiapine Fumarate Drug: Placebo
Study Arms / Comparison Groups	Experimental: 1st fixed dose Experimental: 2nd fixed dose Sham Comparator: Placebo
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) 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

Administrative Information
NCT ID ^ICMJE	NCT00621647
Responsible Party	Hans Eriksson / Medical Science Director, AstraZeneca
Study ID Numbers ^ICMJE	5077US/0046, D1446L00002
Study Sponsor ^ICMJE	AstraZeneca
Collaborators ^ICMJE
Investigators ^ICMJE
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