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Seroquel- Agitation Associated With Dementia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00621647
Recruitment Status : Completed
First Posted : February 22, 2008
Last Update Posted : March 25, 2009
Sponsor:
Information provided by:
AstraZeneca

Tracking Information
First Submitted Date  ICMJE February 6, 2008
First Posted Date  ICMJE February 22, 2008
Last Update Posted Date March 25, 2009
Study Start Date  ICMJE September 2002
Actual 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 ]
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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures 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  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple (Participant, Care Provider, 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 Arms  ICMJE
  • 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
Actual Enrollment  ICMJE
 (submitted: February 11, 2008)
333
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2003
Actual 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 55 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00621647
Other Study ID Numbers  ICMJE 5077US/0046
D1446L00002
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hans Eriksson / Medical Science Director, AstraZeneca
Study Sponsor  ICMJE AstraZeneca
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account AstraZeneca
Verification Date March 2009

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