NCT00389064

Brief Summary

The primary purpose of this study is to evaluate whether treatment with (SEROQUEL SR) quetiapine fumarate sustained release (SR) for 9 weeks compared to placebo will improve elderly patients with generalised anxiety disorder. PLEASE NOTE: Seroquel SR and Seroquel extended release(XR) refer to the same formulation. The SR designation was changed to XR after consultation with FDA.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
450

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Sep 2006

Geographic Reach
5 countries

43 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 17, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 18, 2006

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

June 23, 2009

Completed
Last Updated

April 4, 2012

Status Verified

March 1, 2012

Enrollment Period

1.6 years

First QC Date

October 17, 2006

Results QC Date

April 15, 2009

Last Update Submit

March 30, 2012

Conditions

Anxiety Disorders

Keywords

Generalised Anxiety DisorderGAD

Outcome Measures

Primary Outcomes (1)

  • Change in the Hamilton Rating Scale for Anxiety (HAM-A) Total Score

    HAM-A total score ( 0-56 units), 0 is the best, Change : score at week 9 minus score at randomization

    Randomization to Week 9

Secondary Outcomes (10)

  • Change in Health-related Quality of Life as Measured by Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) Percent Maximum Total Score

    Randomization to Week 9

  • Change in the Clinical Global Impression - Severity of Illness (CGI-S) Score

    Randomization to Week 9

  • Change in Psychic Anxiety Factor as Measured by HAM-A Psychic Cluster Score

    Randomization to Week 9

  • Change in Somatic Symptoms as Measured by HAM-A Somatic Cluster Score

    Randomization to Week 9

  • Hamilton Rating Scale for Anxiety (HAM-A) Response.

    Week 9

  • +5 more secondary outcomes

Study Arms (2)

Quetapine XR

EXPERIMENTAL

Tablets orally administered in flexible doses of 50 to 300 mg quetiapine XR once daily.

Drug: Quetiapine XR

Placebo

PLACEBO COMPARATOR

Matching placebo tablets orally administered once daily.

Drug: Placebo

Interventions

Quetiapine XRDRUG

Quetiapine XR 50 mg tablets orally administered in flexible doses of 50 to 300 mg quetiapine XR once daily, in the evening for a 9-week treatment period.

Quetapine XR
PlaceboDRUG

Matching placebo tablets orally administered in flexible doses of 50 to 300 mg once daily, in the evening for a 9-week treatment period.

Placebo

Eligibility Criteria

Age66 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Male or female patients, 66 years or older, with a documented clinical diagnosis of Generalised Anxiety Disorder (GAD).
  • Absence of current episode of major depression.

You may not qualify if:

  • The presence of dementia or other mental disorder than GAD.
  • Serious suicidal risk, uncontrolled hypertension, substance or alcohol abuse.
  • A current diagnosis of cancer or current or past diagnosis of stroke.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (43)

Research Site

Fort Myers, Florida, United States

Location

Research Site

Gainsville, Florida, United States

Location

Research Site

Miami, Florida, United States

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Research Site

Sarasota, Florida, United States

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Research Site

Roswell, Georgia, United States

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Research Site

Boston, Massachusetts, United States

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Research Site

Brooklyn, New York, United States

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Research Site

The Bronx, New York, United States

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Research Site

Avon Lake, Ohio, United States

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Research Site

Eugene, Oregon, United States

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Research Site

Jenkintown, Pennsylvania, United States

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Research Site

Austin, Texas, United States

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Research Site

Houston, Texas, United States

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Research Site

San Antonio, Texas, United States

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Research Site

Tartu, Estonia, Estonia

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Research Site

Tallinn, Estonia

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Research Site

Viljandi, Estonia

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Research Site

Bialystok, Poland

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Research Site

Gorlice, Poland

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Katowice, Poland

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Krakow, Poland

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Leszno, Poland

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Skorzewo, Poland

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Torun, Poland

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Wroclaw, Poland

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Arkhangelsk, Russia

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Izhevsk, Russia

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Research Site

Lipetsk, Russia

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Moscow, Russia

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Research Site

Nizhny Novgorod, Russia

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Research Site

Perm, Russia

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Research Site

Saint Petersburg, Russia

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Research Site

Saratov, Russia

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Research Site

Stavropol, Russia

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Research Site

Voronezh, Russia

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Research Site

Hlevakha, Kyiv Oblast, Ukraine

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Research Site

Dnipro, Ukraine

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Research Site

Dnipropetrovsk, Ukraine

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Research Site

Donetsk, Ukraine

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Research Site

Kiev, Ukraine

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Research Site

Luhansk, Ukraine

Location

Research Site

Odesa, Ukraine

Location

Research Site

Vinnitsa, Ukraine

Location

Related Publications (1)

  • Mezhebovsky I, Magi K, She F, Datto C, Eriksson H. Double-blind, randomized study of extended release quetiapine fumarate (quetiapine XR) monotherapy in older patients with generalized anxiety disorder. Int J Geriatr Psychiatry. 2013 Jun;28(6):615-25. doi: 10.1002/gps.3867. Epub 2012 Oct 16.

    PMID: 23070803DERIVED

MeSH Terms

Conditions

Anxiety DisordersGeneralized Anxiety Disorder

Condition Hierarchy (Ancestors)

Mental Disorders

Results Point of Contact

Title
Gerard Lynch
Organization
AstraZeneca
AZTrial_Results_Posting@astrazeneca.com

Study Officials

  • Ricardo Ruiz, MD

    AstraZeneca

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 17, 2006

First Posted

October 18, 2006

Study Start

September 1, 2006

Primary Completion

April 1, 2008

Study Completion

April 1, 2008

Last Updated

April 4, 2012

Results First Posted

June 23, 2009

Record last verified: 2012-03

Locations

UA(8)PL(8)US(14)ES(3)RU(10)