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.
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
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.
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
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Cedarhurst, New York
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Charleston, South Carolina
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Cincinnati, Ohio
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Cleveland, Ohio
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Dallas, Texas
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Dayton, Ohio
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Escondido, California
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Eugene, Oregon
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Fort Lauderdale, Florida
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Fort Myers, Florida
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Gainsville, Florida
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Glen Burnie, Maryland
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Glendale, California
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Hallandale, Florida
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Hoffman Estates, Illinois
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Irvine, California
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Jacksonville, Florida
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Lafayette, Indiana
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Little Rock, Arkansas
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Maitland, Florida
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Mesa, Arizona
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New York, New York
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Oak Brook, Illinois
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Oklahoma City, Oklahoma
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Orlando, Florida
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Philadelphia, Pennsylvania
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Piscataway, New Jersey
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Raleigh, North Carolina
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Redlands, California
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Richmond, Virginia
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Riverside, California
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Salem, Oregon
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San Antonio, Texas
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Schaumburg, Illinois
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Seattle, Washington
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Sherman Oaks, California
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Shreveport, Louisiana
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St. Petersburg, Florida
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Staten Island, New York
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Tampa, Florida
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Terre Haute, Indiana
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West Palm Beach, Florida
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Westminster, Maryland
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Wichita Falls, Texas
Research Site
Willoughby, Ohio
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 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.
- 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)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Mark A. Smith, MD, PhD, Study director, AstraZeneca
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