AZD7325 Proof of Concept in Patients With Generalized Anxiety Disorder (GAD)

A Phase 2 study testing AZD7325 in people with Anxiety Disorders, run by AstraZeneca at 52 sites in United States.

Completed

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

Trial summary

The purpose of this research study is to determine whether AstraZeneca's drug AZD7325 is safe and effective in the treatment of generalized anxiety disorder. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Anxiety Disorders
What is being tested?: AZD7325
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 725 participants
Where: 52 sitesUnited States
Study dates: Dec 2008to May 2009
Phase: Phase 2
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 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Signed informed consent before any study-related procedures start.
The patient is previously diagnosed with Generalized Anxiety Disorder.
The patient has a HADS-A (anxiety) score ≥10 at both screening and randomization.

Who cannot join

Patient has a lifetime history of schizophrenia or other psychotic disorders
Patient has a history of seizures or seizure disorder.
Patient is pregnant or breast feeding.
Patient has received electroconvulsive treatment (ECT) in the past.

Trial locations and contacts

52 sites in 1 country.

City, postcode or hospital

52 sites in 1 country

United States52 sites

Research Site
Arcadia, California
Research Site
Atlanta, Georgia
Research Site
Baltimore, Maryland
Research Site
Beechwood, Ohio
Research Site
Beverly Hills, California
Research Site
Birmingham, Alabama
Research Site
Bismarck, North Dakota
Research Site
Boston, Massachusetts
Research Site
Cambridge, Massachusetts
Research Site
Cerritos, California
Research Site
Chino, California
Research Site
Cincinnati, Ohio
Research Site
Clementon, New Jersey
Research Site
Encino, California
Research Site
Fort Myers, Florida
Research Site
Fresh Meadows, New York
Research Site
Friendswood, Texas
Research Site
Herndon, Virginia
Research Site
Indianapolis, Indiana
Research Site
Jenkintown, Pennsylvania
Research Site
Libertyville, Illinois
Research Site
Los Alamitos, California
Research Site
Marietta, Georgia
Research Site
Memphis, Tennessee
Research Site
Miami, Florida
Research Site
Middleburg Heights, Ohio
Research Site
Middleton, Wisconsin
Research Site
Mount Kisco, New York
Research Site
New York, New York
Research Site
Norristown, Pennsylvania
Research Site
Norwich, Connecticut
Research Site
Novato, California
Research Site
Oceanside, California
Research Site
Oklahoma City, Oklahoma
Research Site
Overland Park, Kansas
Research Site
Park Ridge, Illinois
Research Site
Pembroke Pines, Florida
Research Site
Portland, Oregon
Research Site
Raleigh, North Carolina
Research Site
Rochester, New York
Research Site
Saint Petersberg, Florida
Research Site
Salt Lake City, Utah
Research Site
San Antonio, Texas
Research Site
San Diego, California
Research Site
Smyrna, Georgia
Research Site
Spokane, Washington
Research Site
St Louis, Missouri
Research Site
Tampa, Florida
Research Site
Tucson, Arizona
Research Site
Winston-Salem, North Carolina
Research Site
Winter Park, Florida
Research Site
Woodstock, Vermont

Other trials in United States

About this study

Official title: A Multi-Center, Randomized, Placebo-Controlled, Double-Blind, Parallel Group, Efficacy and Safety Study of AZD7325 in the Treatment of Generalized Anxiety Disorder (GAD)

The purpose of this research study is to determine whether AstraZeneca's drug AZD7325 is safe and effective in the treatment of generalized anxiety disorder.

Conditions: Anxiety Disorders
Being tested: AZD7325, Placebo
Keywords: Generalized Anxiety Disorder, GAD, Anxiety
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.

AZD7325Drug
2 tablets taken twice a day for 28 days
AZD7325Drug
2 tablets taken twice a day for 28 days
AZD7325Drug
2 tablets taken twice a day for 28 days
PlaceboDrug
2 tablets taken twice a day for 28 days

Study groups in NCT00808249
Study group	Role	What they receive
A-AZD7325 2mg	Experimental	AZD7325 2mg BID Receives: Drug: AZD7325
B-AZD7325 5mg	Experimental	AZD7325 5mg BID Receives: Drug: AZD7325
C-AZD7325 10mg	Experimental	AZD7325 10mg QD Receives: Drug: AZD7325
D-Placebo	Experimental	Placebo Receives: Drug: Placebo

What is being measured

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

Change From Baseline in the Hamilton Rating Scale for Anxiety (HAM-A) Total Score
The HAM -A is a 14-item clinician administered scale for the evaluation of anxiety symptoms. Each HAM-A item is rated on a 0 (not present) to 4 (very severe) scale, higher score indicates high level of anxiety. The HAM-A total score is calculated as the sum of 14 individual scores, with 56 as the maximum.
Measured: From randomization (baseline) to week 4

Secondary outcomes (4)

Change in Hospital Anxiety and Depression Scale for Anxiety (HADS-A) Total Score
The HADS-A is a 7 item, self administered instrument to measure level of anxiety. Each item is a score rate from 0 (happens rarely ) to 3 (happens frequently), and the items are totaled for a maximum score of 21. The mimimum score 0 indicates that the patient rarely suffered from anxiety symptoms.
Measured: From randomization (baseline) to week 4
Change in Psychic Anxiety Symptoms as Measured by HAM-A Psychic Anxiety Factor Score
The HAM-A psychic anxiety factor score is calculated as the sum of 7 HAM-A individual items related with psychic anxiety ( each rated from 0 to 4, 0 is the best). The minimum score for HAM-A psychic anxiety factor is 0 and maximum score is 28, higher score indicates severe psychic anxiety symptoms.
Measured: From baseline (randomization) to week 4
Change in Somatic Symptoms as Measured by HAM-A Somatic Factor Score
The HAM-A somatic factor score is calculated as the sum of 7 individual HAM-A items (each is rated from 0 to 4, 0 is the best) related with somatic anxiety symptoms. The minimum score for HAM-A somatic factor is 0 and maximum score is 28, higher score indicates severe somatic anxiety symptoms
Measured: From baseline ( randomization) to week 4
Change in Sheehan Disability Scale (SDS) Global Total Score
The Sheehan Disability Scale is a patient-rated measure of functional disability in 3 subscales: work, social, and family life. Each subscale is rated from 0 to 10, with 0 as the best. SDS global total score is calculated as the sum of 3 subscales and ranges from 0(unimpaired) to 30 (highly impaired)
Measured: From baseline ( randomization) to week 4

Timeline

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

Dec 2008May 2009

First posted15 Dec 2008 (estimated)
Study startDec 2008
Primary completionMay 2009
Study completionMay 2009

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.
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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 725 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00808249
Sponsor's protocol ID: D1140C00006
Status last verified: Apr 2011
First submitted: 12 Dec 2008
Last updated: 20 Jun 2011
Results posted: Yes, on ClinicalTrials.gov

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?

See locations

Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence

All Anxiety Disorders trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multi-Center, Randomized, Placebo-Controlled, Double-Blind, Parallel Group, Efficacy and Safety Study of AZD7325 in the Treatment of Generalized Anxiety Disorder (GAD)
ClinicalTrials.gov ID: NCT00808249
Acronym / sponsor ID: D1140C00006
Conditions: Anxiety Disorders
Keywords: Generalized Anxiety Disorder, GAD, Anxiety
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 725 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Dec 2008
Primary completion: May 2009 (actual)
Study completion: May 2009 (actual)
First posted: 15 Dec 2008 (estimated)
Results: Posted 19 May 2011

Clinical summary

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

The purpose of this research study is to determine whether AstraZeneca's drug AZD7325 is safe and effective in the treatment of generalized anxiety disorder.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
A-AZD7325 2mg	Experimental	Drug: AZD7325AZD7325 2mg BID
B-AZD7325 5mg	Experimental	Drug: AZD7325AZD7325 5mg BID
C-AZD7325 10mg	Experimental	Drug: AZD7325AZD7325 10mg QD
D-Placebo	Experimental	Drug: PlaceboPlacebo

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Signed informed consent before any study-related procedures start.
The patient is previously diagnosed with Generalized Anxiety Disorder.
The patient has a HADS-A (anxiety) score ≥10 at both screening and randomization.

Key exclusion criteria (4 listed)

Patient has a lifetime history of schizophrenia or other psychotic disorders
Patient has a history of seizures or seizure disorder.
Patient is pregnant or breast feeding.
Patient has received electroconvulsive treatment (ECT) in the past.

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
AZD73252 tablets taken twice a day for 28 days	Drug	A-AZD7325 2mg
AZD73252 tablets taken twice a day for 28 days	Drug	B-AZD7325 5mg
AZD73252 tablets taken twice a day for 28 days	Drug	C-AZD7325 10mg
Placebo2 tablets taken twice a day for 28 days	Drug	D-Placebo

Primary outcome

Change From Baseline in the Hamilton Rating Scale for Anxiety (HAM-A) Total Score
Time frame: From randomization (baseline) to week 4
The HAM -A is a 14-item clinician administered scale for the evaluation of anxiety symptoms. Each HAM-A item is rated on a 0 (not present) to 4 (very severe) scale, higher score indicates high level of anxiety. The HAM-A total score is calculated as the sum of 14 individual scores, with 56 as the maximum.

4 secondary outcomes

Change in Hospital Anxiety and Depression Scale for Anxiety (HADS-A) Total Score
Time frame: From randomization (baseline) to week 4
Change in Psychic Anxiety Symptoms as Measured by HAM-A Psychic Anxiety Factor Score
Time frame: From baseline (randomization) to week 4
Change in Somatic Symptoms as Measured by HAM-A Somatic Factor Score
Time frame: From baseline ( randomization) to week 4
Change in Sheehan Disability Scale (SDS) Global Total Score
Time frame: From baseline ( randomization) to week 4

Results and safety

Results posted to the registry on 19 May 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
A-AZD7325 2 mg	107	90
B-AZD7325 5 mg	106	91
C-AZD7325 10 mg	105	83
D-Placebo	106	90

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

Time frame: From randomization (baseline) to week 4. Least squares mean (Standard Error). Unit: Units on scale

Measure	A-AZD7325 2 mg n = 105	B-AZD7325 5 mg n = 105	C-AZD7325 10 mg n = 103	D-Placebo n = 102
Value	-10.9 (0.87)	-11.1 (0.86)	-11.5 (0.87)	-10.9 (0.88)

4 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
A-AZD7325 2 mg	1 of ?	13 of ?	Not reported
B-AZD7325 5 mg	1 of ?	18 of ?	Not reported
C-AZD7325 10 mg	0 of ?	32 of ?	Not reported
D-Placebo	0 of ?	14 of ?	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2011.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Anxiety Disorders

Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence

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.

Mark A. Smith, MD, PhD study director

AstraZeneca

David V. Sheehan principal investigator

University of South Florida College of Medicine

52 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AZD7325 in people with Anxiety Disorders, run by AstraZeneca at 52 sites in United States.

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 3 inclusion and 4 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 20 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 52 sites in United States. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 19 May 2011). 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 From Baseline in the Hamilton Rating Scale for Anxiety (HAM-A) Total Score (time frame: From randomization (baseline) to week 4). 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 NCT00808249.

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 20 Jun 2011.