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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A-AZD7325 2mg | Experimental | AZD7325 2mg BID |
|
| B-AZD7325 5mg | Experimental | AZD7325 5mg BID |
|
| C-AZD7325 10mg | Experimental | AZD7325 10mg QD |
|
| D-Placebo | Experimental | Placebo |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD7325 | Drug | 2 tablets taken twice a day for 28 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From randomization (baseline) to week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From randomization (baseline) to week 4 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark A. Smith, MD, PhD | AstraZeneca | Study Director |
| David V. Sheehan | University of South Florida College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Birmingham | Alabama | United States | |||
| Research Site |
Screening for eligibility and wash-out of restriced medications. 725 subjects enrolled but 424 subjects were randomized. Number of participants analyzed is the number of subjects in MITT (modified intent to treat) population, it is different with any of population listed in the participant flow chart.
International multi-center study, 44 sites recruited between Dec 2008 and May 2009
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| ID | Title | Description |
|---|---|---|
| FG000 | A-AZD7325 2 mg | AZD7325 2 mg BID |
| FG001 | B-AZD7325 5 mg | AZD7325 5 mg BID |
| FG002 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| AZD7325 |
| Drug |
2 tablets taken twice a day for 28 days |
|
| AZD7325 | Drug | 2 tablets taken twice a day for 28 days |
|
| Placebo | Drug | 2 tablets taken twice a day for 28 days |
|
| 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. | 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 | 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) | From baseline ( randomization) to week 4 |
| Tucson |
| Arizona |
| United States |
| Research Site | Arcadia | California | United States |
| Research Site | Beverly Hills | California | United States |
| Research Site | Cerritos | California | United States |
| Research Site | Chino | California | United States |
| Research Site | Encino | California | United States |
| Research Site | Los Alamitos | California | United States |
| Research Site | Novato | California | United States |
| Research Site | Oceanside | California | United States |
| Research Site | San Diego | California | United States |
| Research Site | Norwich | Connecticut | United States |
| Research Site | Fort Myers | Florida | United States |
| Research Site | Miami | Florida | United States |
| Research Site | Pembroke Pines | Florida | United States |
| Research Site | Saint Petersberg | Florida | United States |
| Research Site | Tampa | Florida | United States |
| Research Site | Winter Park | Florida | United States |
| Research Site | Atlanta | Georgia | United States |
| Research Site | Marietta | Georgia | United States |
| Research Site | Smyrna | Georgia | United States |
| Research Site | Libertyville | Illinois | United States |
| Research Site | Park Ridge | Illinois | United States |
| Research Site | Indianapolis | Indiana | United States |
| Research Site | Overland Park | Kansas | United States |
| Research Site | Baltimore | Maryland | United States |
| Research Site | Boston | Massachusetts | United States |
| Research Site | Cambridge | Massachusetts | United States |
| Research Site | St Louis | Missouri | United States |
| Research Site | Clementon | New Jersey | United States |
| Research Site | Fresh Meadows | New York | United States |
| Research Site | Mount Kisco | New York | United States |
| Research Site | New York | New York | United States |
| Research Site | Rochester | New York | United States |
| Research Site | Raleigh | North Carolina | United States |
| Research Site | Winston-Salem | North Carolina | United States |
| Research Site | Bismarck | North Dakota | United States |
| Research Site | Beechwood | Ohio | United States |
| Research Site | Cincinnati | Ohio | United States |
| Research Site | Middleburg Heights | Ohio | United States |
| Research Site | Oklahoma City | Oklahoma | United States |
| Research Site | Portland | Oregon | United States |
| Research Site | Jenkintown | Pennsylvania | United States |
| Research Site | Norristown | Pennsylvania | United States |
| Research Site | Memphis | Tennessee | United States |
| Research Site | Friendswood | Texas | United States |
| Research Site | San Antonio | Texas | United States |
| Research Site | Salt Lake City | Utah | United States |
| Research Site | Woodstock | Vermont | United States |
| Research Site | Herndon | Virginia | United States |
| Research Site | Spokane | Washington | United States |
| Research Site | Middleton | Wisconsin | United States |
| C-AZD7325 10 mg |
AZD7325 10 mg QD |
| FG003 | D-Placebo | Placebo |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | A-AZD7325 2 mg | AZD7325 2 mg BID |
| BG001 | B-AZD7325 5 mg | AZD7325 5 mg BID |
| BG002 | C-AZD7325 10 mg | AZD7325 10 mg QD |
| BG003 | D-Placebo | Placebo |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Least Squares Mean | Standard Error | Units on scale | From randomization (baseline) to week 4 |
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| Secondary | 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. | Posted | Least Squares Mean | Standard Error | Units on scale | From randomization (baseline) to week 4 |
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| Secondary | 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. | Posted | Least Squares Mean | Standard Error | Unit on scale | From baseline (randomization) to week 4 |
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| Secondary | 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 | Posted | Least Squares Mean | Standard Error | Units on scale | From baseline ( randomization) to week 4 |
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| Secondary | 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) | Posted | Least Squares Mean | Standard Error | Units on scale | From baseline ( randomization) to week 4 |
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Number at risk is number of patients in safety population. The participant flow shows patients randomized and completed the study. The numbers are not the same since 2 patients were randomized but did not take study drug.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | A-AZD7325 2 mg | AZD7325 2 mg BID | 1 | 13 | ||||
| EG001 | B-AZD7325 5 mg | AZD7325 5 mg BID | 1 | 18 | ||||
| EG002 | C-AZD7325 10 mg | AZD7325 10 mg QD | 0 | 32 | ||||
| EG003 | D-Placebo | Placebo | 0 | 14 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Road Traffic Accident | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
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| Grand Mal Convulsion | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
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| Deep Vein Thrombosis | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dizziness | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
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| Sedation | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
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| Euphoric Mood | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
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| Dry Mouth | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 12.0 | Systematic Assessment |
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| Feeling Abnormal | General disorders | MedDRA 12.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gerard Lynch | AstraZeneca | aztrial_results_posting@astrazeneca.com |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D000098647 | Generalized Anxiety Disorder |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C576237 | 4-amino-8-(2-fluoro-6-methoxy-phenyl)-N-propylcinnoline-3-carboxamide |
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| 40-65 |
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| Male |
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| Participants |
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| Participants |
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