Anxiety Disorders Clinical Trial
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)
| Verified date | September 2010 |
| Source | AstraZeneca |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 369 |
| Est. completion date | May 2009 |
| Est. primary completion date | May 2009 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 65 Years |
| Eligibility |
Inclusion Criteria: - 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. Exclusion Criteria: - 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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Research Site | Allentown | Pennsylvania |
| United States | Research Site | Atlanta | Georgia |
| United States | Research Site | Austin | Texas |
| United States | Research Site | Bartlett | Tennessee |
| United States | Research Site | Braintree | Massachusetts |
| United States | Research Site | Carson | California |
| United States | Research Site | Cedarhurst | New York |
| United States | Research Site | Charleston | South Carolina |
| United States | Research Site | Cincinnati | Ohio |
| United States | Research Site | Cleveland | Ohio |
| United States | Research Site | Dallas | Texas |
| United States | Research Site | Dayton | Ohio |
| United States | Research Site | Escondido | California |
| United States | Research Site | Eugene | Oregon |
| United States | Research Site | Fort Lauderdale | Florida |
| United States | Research Site | Fort Myers | Florida |
| United States | Research Site | Gainsville | Florida |
| United States | Research Site | Glen Burnie | Maryland |
| United States | Research Site | Glendale | California |
| United States | Research Site | Hallandale Beach | Florida |
| United States | Research Site | Hoffman Estates | Illinois |
| United States | Research Site | Irvine | California |
| United States | Research Site | Jacksonville | Florida |
| United States | Research Site | Lafayette | Indiana |
| United States | Research Site | Little Rock | Arkansas |
| United States | Research Site | Maitland | Florida |
| United States | Research Site | Mesa | Arizona |
| United States | Research Site | New York | New York |
| United States | Research Site | Oak Brook | Illinois |
| United States | Research Site | Oklahoma City | Oklahoma |
| United States | Research Site | Orlando | Florida |
| United States | Research Site | Philadelphia | Pennsylvania |
| United States | Research Site | Piscataway | New Jersey |
| United States | Research Site | Raleigh | North Carolina |
| United States | Research Site | Redlands | California |
| United States | Research Site | Richmond | Virginia |
| United States | Research Site | Riverside | California |
| United States | Research Site | Salem | Oregon |
| United States | Research Site | San Antonio | Texas |
| United States | Research Site | Schaumburg | Illinois |
| United States | Research Site | Seattle | Washington |
| United States | Research Site | Sherman Oaks | California |
| United States | Research Site | Shreveport | Louisiana |
| United States | Research Site | St. Petersburg | Florida |
| United States | Research Site | Staten Island | New York |
| United States | Research Site | Tampa | Florida |
| United States | Research Site | Terre Haute | Indiana |
| United States | Research Site | West Palm Beach | Florida |
| United States | Research Site | Westminster | Maryland |
| United States | Research Site | Wichita Falls | Texas |
| United States | Research Site | Willoughby | Ohio |
| Lead Sponsor | Collaborator |
|---|---|
| AstraZeneca |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Baseline to week 4 | No |
| Secondary | 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 | Baseline to week 4 | No |
| Secondary | 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 |
Baseline to week 4 | No |
| Secondary | 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. | Baseline to week 4 | No |
| Secondary | 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 |
Baseline to week 4 | No |
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