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

February 6, 2008
March 24, 2009
September 2002
November 2003   (final data collection date for primary outcome measure)
To assess the efficacy of 2 fixed doses of quetiapine compared with placebo [ Time Frame: Twice weekly ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00621647 on ClinicalTrials.gov Archive Site
To assess the efficacy of quetiapine compared with placebo [ Time Frame: Twice weekly ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
  • Alzheimer's Disease
  • Vascular Dementia
  • Drug: Quetiapine Fumarate
    Other Name: Seroquel
  • Drug: Quetiapine Fumarate
  • Drug: Placebo
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
333
November 2003
November 2003   (final data collection date for primary outcome measure)

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
Both
55 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00621647
5077US/0046, D1446L00002
No
Hans Eriksson / Medical Science Director, AstraZeneca
AstraZeneca
Not Provided
Not Provided
AstraZeneca
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP