Anxiety DisordersPhase 2NCT00807937

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

A Phase 2 study testing AZD7325 and Lorazepam in people with Anxiety Disorders, run by AstraZeneca at 51 sites in United States.

Completed

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

Official record

Search all trials

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 and Lorazepam
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 369 participants
Where: 51 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

51 sites in 1 country.

City, postcode or hospital

51 sites in 1 country

United States51 sites

Research Site
Allentown, Pennsylvania
Research Site
Atlanta, Georgia
Research Site
Austin, Texas
Research Site
Bartlett, Tennessee
Research Site
Braintree, Massachusetts
Research Site
Carson, California
Research Site
Cedarhurst, New York
Research Site
Charleston, South Carolina
Research Site
Cincinnati, Ohio
Research Site
Cleveland, Ohio
Research Site
Dallas, Texas
Research Site
Dayton, Ohio
Research Site
Escondido, California
Research Site
Eugene, Oregon
Research Site
Fort Lauderdale, Florida
Research Site
Fort Myers, Florida
Research Site
Gainsville, Florida
Research Site
Glen Burnie, Maryland
Research Site
Glendale, California
Research Site
Hallandale, Florida
Research Site
Hoffman Estates, Illinois
Research Site
Irvine, California
Research Site
Jacksonville, Florida
Research Site
Lafayette, Indiana
Research Site
Little Rock, Arkansas
Research Site
Maitland, Florida
Research Site
Mesa, Arizona
Research Site
New York, New York
Research Site
Oak Brook, Illinois
Research Site
Oklahoma City, Oklahoma
Research Site
Orlando, Florida
Research Site
Philadelphia, Pennsylvania
Research Site
Piscataway, New Jersey
Research Site
Raleigh, North Carolina
Research Site
Redlands, California
Research Site
Richmond, Virginia
Research Site
Riverside, California
Research Site
Salem, Oregon
Research Site
San Antonio, Texas
Research Site
Schaumburg, Illinois
Research Site
Seattle, Washington
Research Site
Sherman Oaks, California
Research Site
Shreveport, Louisiana
Research Site
St. Petersburg, Florida
Research Site
Staten Island, New York
Research Site
Tampa, Florida
Research Site
Terre Haute, Indiana
Research Site
West Palm Beach, Florida
Research Site
Westminster, Maryland
Research Site
Wichita Falls, Texas
Research Site
Willoughby, Ohio

Other trials in United States

About this study

Official title: A Multi-Center, Randomized, Placebo-Controlled, Double-Blind, Parallel Group, Phase II Study of 2 Oral Dose Groups of AZD7325, With a Lorazepam Arm, in Subjects With 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, Lorazepam, 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
4 tablets and 1 capsule taken twice a day for 28 days
AZD7325Drug
4 tablets and 1 capsule taken twice a day for 28 days
LorazepamDrug
4 tablets and 1 capsule taken twice a day for 28 days
PlaceboDrug
4 tablets and 1 capsule taken twice a day for 28 days

Study groups in NCT00807937
Study group	Role	What they receive
A	Experimental	AZD7325 5mg twice daily Receives: Drug: AZD7325
B	Experimental	AZD7325 15mg twice daily Receives: Drug: AZD7325
C	Active comparator	Lorazepam 2mg twice daily Receives: Drug: Lorazepam
D	Placebo comparator	Placebo 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, 14 questions scored on scale of 0-4 (0= Not present, 4=Very severe) . Higher HAM-A scores indicate higher levels of anxiety Change : score at week 4 minus score at randomization
Measured: Baseline to week 4

Secondary outcomes (4)

Change in Hospital Anxiety and Depression Scale for Anxiety (HADS-A) Total Score
HADS-A total score 0-21 units, 0 is the best, Higher total scores indicate a higher severity of the mood or anxiety disorder Change : score at week 4 minus score at randomization
Measured: Baseline to week 4
Change in Psychic Anxiety Factor as Measured by HAM-A Psychic Cluster Score
The HAM-A psychic anxiety cluster score 0-28 units consists of 7 questions scored on scale of 0-4 (0=Not present, 4=Very severe) . Higher scores indicate higher levels of psychic anxiety disorder.
Change: score at week 4 minus score at randomization
Measured: Baseline to week 4
Change in Somatic Symptoms as Measured by HAM-A Somatic Cluster Score
The HAM-A Somatic cluster score 0-28 units consists of 7 questions scored on scale of 0-4 (0=Not present, 4=Very severe ) . Higher scores indicate higher levels of psychic anxiety disorder.
Measured: Baseline to week 4
Change in Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q-SF) Percent Maximum Total Score
Q-LES-Q total score is the sum of the first 14 times of Q-LES-Q, and this total score is converted to a % maximum total score by : Q-LES-Q total score /70 x 100%, Larger values indicate a higher perceived quality of life enjoyment and satisfaction.
Change : percentage at week 4 minus percentage at randomization
Measured: Baseline 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: 369 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00807937
Sponsor's protocol ID: D1140C00014
Status last verified: Sep 2010
First submitted: 12 Dec 2008
Last updated: 8 Oct 2010
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 8 Oct 2010. 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, Phase II Study of 2 Oral Dose Groups of AZD7325, With a Lorazepam Arm, in Subjects With Generalized Anxiety Disorder (GAD)
ClinicalTrials.gov ID: NCT00807937
Acronym / sponsor ID: D1140C00014
Conditions: Anxiety Disorders
Keywords: Generalized Anxiety Disorder, GAD, Anxiety
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 369 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 8 Oct 2010

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	Experimental	Drug: AZD7325AZD7325 5mg twice daily
B	Experimental	Drug: AZD7325AZD7325 15mg twice daily
C	Active comparator	Drug: LorazepamLorazepam 2mg twice daily
D	Placebo comparator	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
AZD73254 tablets and 1 capsule taken twice a day for 28 days	Drug	A
AZD73254 tablets and 1 capsule taken twice a day for 28 days	Drug	B
Lorazepam4 tablets and 1 capsule taken twice a day for 28 days	Drug	C
Placebo4 tablets and 1 capsule taken twice a day for 28 days	Drug	D

Primary outcome

Change in the Hamilton Rating Scale for Anxiety (HAM-A) Total Score
Time frame: Baseline to week 4
HAM-A total score 0-56 units, 14 questions scored on scale of 0-4 (0= Not present, 4=Very severe) . Higher HAM-A scores indicate higher levels of anxiety Change : score at week 4 minus score at randomization

4 secondary outcomes

Change in Hospital Anxiety and Depression Scale for Anxiety (HADS-A) Total Score
Time frame: Baseline to week 4
Change in Psychic Anxiety Factor as Measured by HAM-A Psychic Cluster Score
Time frame: Baseline to week 4
Change in Somatic Symptoms as Measured by HAM-A Somatic Cluster Score
Time frame: Baseline to week 4
Change in Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q-SF) Percent Maximum Total Score
Time frame: Baseline to week 4

Results and safety

Results posted to the registry on 8 Oct 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
AZD7325 5 mg	93	66
AZD7325 15 mg	92	67
Lorazepam	92	78
Placebo	92	77

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

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

Measure	AZD7325 5 mg n = 89	AZD7325 15 mg n = 89	Lorazepam n = 91	Placebo n = 90
Value	-10.1 (0.89)	-10.4 (0.89)	-10.8 (0.88)	-9.5 (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
AZD7325 5 mg	0 of 93 (0%)	63 of 93 (67.7%)	Not reported
AZD7325 15 mg	0 of 92 (0%)	59 of 92 (64.1%)	Not reported
Lorazepam	0 of 92 (0%)	65 of 92 (70.7%)	Not reported
Placebo	0 of 92 (0%)	51 of 92 (55.4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2010.
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

51 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 and Lorazepam in people with Anxiety Disorders, run by AstraZeneca at 51 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 8 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 51 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. 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 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 8 Oct 2010). 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: 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 NCT00807937.

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 8 Oct 2010.