Seroquel- Agitation Associated With Dementia

Sponsor

AstraZeneca (Industry)

Overall Status

Completed

CT.gov ID

NCT00621647

Collaborator

(none)

333

Enrollment

Arms

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Alzheimer's Disease Vascular Dementia	Drug: Quetiapine Fumarate Drug: Quetiapine Fumarate Drug: Placebo	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

333 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Masking:

Triple (Participant, Care Provider, 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.

Study Start Date :

Sep 1, 2002

Actual Primary Completion Date :

Nov 1, 2003

Actual Study Completion Date :

Nov 1, 2003

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 1st fixed dose	Drug: Quetiapine Fumarate Other Names: Seroquel
Experimental: 2 2nd fixed dose	Drug: Quetiapine Fumarate
Sham Comparator: 3 Placebo	Drug: Placebo

Arm

Intervention/Treatment

Experimental: 1

1st fixed dose

Drug: Quetiapine Fumarate

Other Names:

Seroquel

Experimental: 2

2nd fixed dose

Drug: Quetiapine Fumarate

Sham Comparator: 3

Placebo

Drug: Placebo

Outcome Measures

Primary Outcome Measures

To assess the efficacy of 2 fixed doses of quetiapine compared with placebo [Twice weekly]

Secondary Outcome Measures

To assess the efficacy of quetiapine compared with placebo [Twice weekly]

Eligibility Criteria

Criteria

Ages Eligible for Study:

55 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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