Seroquel- Agitation Associated With Dementia | NCT00621647

Studies
Seroquel- Agitation Associated With Dementia

NCT00621647

Sponsor

AstraZeneca

Status

Completed

Last Update Posted

Mar 25, 2009Estimated

Enrollment

333Actual

Phase

Phase 3

Conditions

Alzheimer's Disease
Vascular Dementia

Interventions

Quetiapine Fumarate
Quetiapine Fumarate
Placebo

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
D1446L00002

Status Module

Record Verification Date

Mar 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2002

Primary Completion Date

Nov 2003Actual

Completion Date

Nov 2003Actual

First Submitted Date

Feb 6, 2008

First Submission Date that Met QC Criteria

Feb 11, 2008

First Posted Date

Feb 22, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 24, 2009

Last Update Posted Date

Mar 25, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

333Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	1st fixed dose	Drug: Quetiapine Fumarate
2	Experimental	2nd fixed dose	Drug: Quetiapine Fumarate
3	Sham Comparator	Placebo	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Quetiapine Fumarate	Drug		1	Seroquel
Quetiapine Fumarate

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To assess the efficacy of 2 fixed doses of quetiapine compared with placebo		Twice weekly

Secondary Outcomes

Measure	Description	Time Frame
To assess the efficacy of quetiapine compared with placebo		Twice weekly

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

55 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000544	Alzheimer Disease
D015140	Dementia, Vascular
D003704	Dementia

Ancestor Terms

ID	Term
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D024801	Tauopathies

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000069348	Quetiapine Fumarate

Ancestor Terms

ID	Term
D003987	Dibenzothiazepines
D013841	Thiazepines
D013846	Thiepins
D013457	Sulfur Compounds

Browse Leaves

Not provided

Browse Branches

Not provided