Efficacy and Safety Study of Seroquel SR in the Treatment of Generalised Anxiety Disorder

A Phase 3 study testing Quetiapine XR in people with Anxiety Disorders, run by AstraZeneca at 43 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 66 years and older
Conditions the study is for: Anxiety Disorders
What is being tested?: Quetiapine XR
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 450 participants
Where: 43 sitesin 5 countries
Study dates: Sep 2006to Apr 2008
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 66 years and older
All sexes
No healthy volunteers
Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

43 sites in 5 countries.

Country

City, postcode or hospital

43 sites in 5 countries

United States14 sites

Research Site
Austin, Texas
Research Site
Avon Lake, Ohio
Research Site
Boston, Massachusetts
Research Site
Brooklyn, New York
Research Site
Eugene, Oregon
Research Site
Fort Myers, Florida
Research Site
Gainsville, Florida
Research Site
Houston, Texas
Research Site
Jenkintown, Pennsylvania
Research Site
Miami, Florida
Research Site
Roswell, Georgia
Research Site
San Antonio, Texas
Research Site
Sarasota, Florida
Research Site
The Bronx, New York

Other trials in United States

Russia10 sites

Research Site
Arkhangelsk
Research Site
Izhevsk
Research Site
Lipetsk
Research Site
Moscow
Research Site
Nizhny Novgorod
Research Site
Perm
Research Site
Saint Petersburg
Research Site
Saratov
Research Site
Stavropol
Research Site
Voronezh

Other trials in Russia

Poland8 sites

Research Site
Bialystok
Research Site
Gorlice
Research Site
Katowice
Research Site
Krakow
Research Site
Leszno
Research Site
Skorzewo
Research Site
Torun
Research Site
Wroclaw

Other trials in Poland

Ukraine8 sites

Research Site
Dnipro
Research Site
Dnipropetrovsk
Research Site
Donetsk
Research Site
Hlevakha, Kyiv Oblast
Research Site
Kiev
Research Site
Luhansk
Research Site
Odesa
Research Site
Vinnitsa

Other trials in Ukraine

Estonia3 sites

Research Site
Tallinn
Research Site
Tartu, Estonia
Research Site
Viljandi

Other trials in Estonia

About this study

Official title: A Multi-Centre, Double-Blind, Randomised, Parallel-Group, Placebo-Controlled Phase III Study of the Efficacy and Safety of Quetiapine Fumarate Sustained Release (Seroquel SR) in the Treatment of 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.

Conditions: Anxiety Disorders
Being tested: Quetiapine XR, Placebo
Keywords: Generalised Anxiety Disorder, GAD
Medical subject headings: Anxiety Disorders, Generalized Anxiety Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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.
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.

Study groups in NCT00389064
Study group	Role	What they receive
Quetapine XR	Experimental	Tablets orally administered in flexible doses of 50 to 300 mg quetiapine XR once daily. Receives: Drug: Quetiapine XR
Placebo	Placebo comparator	Matching placebo tablets orally administered once daily. Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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
Q-LES-Q total score is the sum of the first 14 items of Q-LES-Q, and this total score is converted to a % maximum total score by : (Q-LES-Q total score -14) /56 x 100%, Larger values indicate a higher perceived quality of life enjoyment and satisfaction.
Change : percentage at week 9 minus percentage at randomization
Measured: Randomization to Week 9
Change in the Clinical Global Impression - Severity of Illness (CGI-S) Score
CGI-S score is accessed on a seven-graded scale ranging from most extremely ill/ very much worse (7) to normal/very much improved (1) , 1 is best Change : score at week 9 minus score at randomization
Measured: Randomization to Week 9
Change in Psychic Anxiety Factor as Measured by HAM-A Psychic Cluster Score
HAM-A psychic cluster score ( 0-28), 0 is the best Change : score at week 9 minus score at randomization
Measured: Randomization to Week 9
Change in Somatic Symptoms as Measured by HAM-A Somatic Cluster Score
HAM-A somatic cluster score (0-28), 0 is the best Change : score at week 9 minus score at randomization
Measured: Randomization to Week 9
Hamilton Rating Scale for Anxiety (HAM-A) Response.
HAM-A response, defined as 50% or greater reduction from randomization in HAM-A total score.
Measured: Week 9
Number of Patients Reaching Hamilton Rating Scale for Anxiety (HAM-A) Remission
HAM-A remission, defined as HAM-A total score less or equal to 7. An indicator of HAM-A remission is calculated as:
- If HAM-A total score≤7, THEN indicator=1
- If HAM-A total score >7, THEN indicator=0
Measured: Week 9
Change in Montgomery-Asberg Depression Rating Scale (MADRS)
MADRS total score (0-60), 0 is best Change : score at week 9 minus score at randomization
Measured: Randomization to week 9
Change in the Visual Analogue Scale (VAS) Measuring Pain
Visual Analogue Scale (VAS) measuring pain (0-100 mm), 0 is best Change : scale at week 9 minus scale at randomization
Measured: Randomization to week 9
Safety and Well Tolerated as Measured in Adverse Event
Number of patients have at least one adverse event
Measured: From the start of treatment to last dose plus 30 days
Safety and Well Tolerated as Measured by Extra Pyramidal Symptoms (EPS)
Number of patients have adverse events associated with EPS
Measured: From start of the study teatment to last dose plus 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2006Apr 2008

First posted18 Oct 2006 (estimated)
Study startSep 2006
Primary completionApr 2008
Study completionApr 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Anxiety DisordersStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 450 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00389064
Sponsor's protocol ID: D1448C00015
Other IDs: EUDRACT No: 2006-001195-21
Status last verified: Mar 2012
First submitted: 17 Oct 2006
Last updated: 4 Apr 2012
Results posted: Yes, on ClinicalTrials.gov

Publications

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.
PubMed 23070803

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 4 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multi-Centre, Double-Blind, Randomised, Parallel-Group, Placebo-Controlled Phase III Study of the Efficacy and Safety of Quetiapine Fumarate Sustained Release (Seroquel SR) in the Treatment of Elderly Patients With Generalised Anxiety Disorder
ClinicalTrials.gov ID: NCT00389064
Acronym / sponsor ID: D1448C00015
Conditions: Anxiety Disorders
Keywords: Generalised Anxiety Disorder, GAD
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 450 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Sep 2006
Primary completion: Apr 2008 (actual)
Study completion: Apr 2008 (actual)
First posted: 18 Oct 2006 (estimated)
Results: Posted 23 Jun 2009

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Quetapine XR	Experimental	Drug: Quetiapine XRTablets orally administered in flexible doses of 50 to 300 mg quetiapine XR once daily.
Placebo	Placebo comparator	Drug: PlaceboMatching placebo tablets orally administered once daily.

Who may qualify

Ages: 66 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Older adult

Key inclusion criteria (2 listed)

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.

Key exclusion criteria (3 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Quetiapine XRQuetiapine 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.	Drug	Quetapine XR
PlaceboMatching placebo tablets orally administered in flexible doses of 50 to 300 mg once daily, in the evening for a 9-week treatment period.	Drug	Placebo

Primary outcome

Change in the Hamilton Rating Scale for Anxiety (HAM-A) Total Score
Time frame: Randomization to Week 9
HAM-A total score ( 0-56 units), 0 is the best, Change : score at week 9 minus score at randomization

10 secondary outcomes

Change in Health-related Quality of Life as Measured by Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) Percent Maximum Total Score
Time frame: Randomization to Week 9
Change in the Clinical Global Impression - Severity of Illness (CGI-S) Score
Time frame: Randomization to Week 9
Change in Psychic Anxiety Factor as Measured by HAM-A Psychic Cluster Score
Time frame: Randomization to Week 9
Change in Somatic Symptoms as Measured by HAM-A Somatic Cluster Score
Time frame: Randomization to Week 9
Hamilton Rating Scale for Anxiety (HAM-A) Response.
Time frame: Week 9
Number of Patients Reaching Hamilton Rating Scale for Anxiety (HAM-A) Remission
Time frame: Week 9
Change in Montgomery-Asberg Depression Rating Scale (MADRS)
Time frame: Randomization to week 9
Change in the Visual Analogue Scale (VAS) Measuring Pain
Time frame: Randomization to week 9
Safety and Well Tolerated as Measured in Adverse Event
Time frame: From the start of treatment to last dose plus 30 days
Safety and Well Tolerated as Measured by Extra Pyramidal Symptoms (EPS)
Time frame: From start of the study teatment to last dose plus 30 days

Results and safety

Results posted to the registry on 23 Jun 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Quetiapine XR	223	178
Placebo	227	168

Primary outcome: Change in the Hamilton Rating Scale for Anxiety (HAM-A) Total Score

Time frame: Randomization to Week 9. Least squares mean (Standard Deviation). Unit: units on scale

Measure	Quetiapine XR n = 222	Placebo n = 226
Value	-14.97 (7.4)	-7.21 (7.8)

Population analysed: Modified Intent to Treat (MITT) population.

10 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Quetiapine XR	1 of 223 (0.4%)	171 of 223 (76.7%)	Not reported
Placebo	3 of 227 (1.3%)	89 of 227 (39.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 23070803Mezhebovsky 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Ricardo Ruiz, MD study director

AstraZeneca

43 sites in 5 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Quetiapine XR in people with Anxiety Disorders, run by AstraZeneca at 43 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 43 sites in United States, Russia, Poland, Ukraine, Estonia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Jun 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in the Hamilton Rating Scale for Anxiety (HAM-A) Total Score (time frame: Randomization to Week 9). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00389064, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2012.