Proof of Concept in Patients With Generalized Anxiety Disorder (GAD)AZD7325
Overview[ - collapse ][ - ]
| Purpose | 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. |
|---|---|
| Condition | Anxiety Disorders |
| Intervention | Drug: AZD7325 Drug: AZD7325 Drug: Lorazepam Drug: Placebo |
| Phase | Phase 2 |
| Sponsor | AstraZeneca |
| Responsible Party | AstraZeneca |
| ClinicalTrials.gov Identifier | NCT00807937 |
| First Received | December 12, 2008 |
| Last Updated | September 16, 2010 |
| Last verified | September 2010 |
Tracking Information[ + expand ][ + ]
| First Received Date | December 12, 2008 |
|---|---|
| Last Updated Date | September 16, 2010 |
| Start Date | December 2008 |
| Estimated Primary Completion Date | May 2009 |
| Current Primary Outcome Measures | Change in the Hamilton Rating Scale for Anxiety (HAM-A) Total Score [Time Frame: Baseline to week 4] [Designated as safety issue: No]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 |
| Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
| Brief Title | Proof of Concept in Patients With Generalized Anxiety Disorder (GAD)AZD7325 |
|---|---|
| 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) |
| Brief 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. |
| Detailed Description | Not Provided |
| Study Type | Interventional |
| Study Phase | Phase 2 |
| Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment |
| Condition | Anxiety Disorders |
| Intervention | Drug: AZD7325 4 tablets and 1 capsule taken twice a day for 28 days Drug: AZD7325 4 tablets and 1 capsule taken twice a day for 28 days Drug: Lorazepam 4 tablets and 1 capsule taken twice a day for 28 days Drug: Placebo 4 tablets and 1 capsule taken twice a day for 28 days |
| Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
|---|---|
| Estimated Enrollment | 369 |
| Estimated Completion Date | May 2009 |
| Estimated Primary Completion Date | May 2009 |
| Eligibility Criteria | 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. |
| Gender | Both |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | United States |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00807937 |
|---|---|
| Other Study ID Numbers | D1140C00014 |
| Has Data Monitoring Committee | Not Provided |
| Information Provided By | AstraZeneca |
| Study Sponsor | AstraZeneca |
| Collaborators | Not Provided |
| Investigators | Study Director: Mark A. Smith, MD, PhD AstraZeneca |
| Verification Date | September 2010 |
Locations[ + expand ][ + ]
| Research Site | Mesa, Arizona, United States |
|---|---|
| Research Site | Little Rock, Arkansas, United States |
| Research Site | Carson, California, United States |
| Research Site | Escondido, California, United States |
| Research Site | Glendale, California, United States |
| Research Site | Irvine, California, United States |
| Research Site | Redlands, California, United States |
| Research Site | Riverside, California, United States |
| Research Site | Sherman Oaks, California, United States |
| Research Site | Fort Lauderdale, Florida, United States |
| Research Site | Fort Myers, Florida, United States |
| Research Site | Gainsville, Florida, United States |
| Research Site | Hallandale Beach, Florida, United States |
| Research Site | Jacksonville, Florida, United States |
| Research Site | Maitland, Florida, United States |
| Research Site | Orlando, Florida, United States |
| Research Site | St. Petersburg, Florida, United States |
| Research Site | Tampa, Florida, United States |
| Research Site | West Palm Beach, Florida, United States |
| Research Site | Atlanta, Georgia, United States |
| Research Site | Hoffman Estates, Illinois, United States |
| Research Site | Oak Brook, Illinois, United States |
| Research Site | Schaumburg, Illinois, United States |
| Research Site | Lafayette, Indiana, United States |
| Research Site | Terre Haute, Indiana, United States |
| Research Site | Shreveport, Louisiana, United States |
| Research Site | Glen Burnie, Maryland, United States |
| Research Site | Westminster, Maryland, United States |
| Research Site | Braintree, Massachusetts, United States |
| Research Site | Piscataway, New Jersey, United States |
| Research Site | Cedarhurst, New York, United States |
| Research Site | New York, New York, United States |
| Research Site | Staten Island, New York, United States |
| Research Site | Raleigh, North Carolina, United States |
| Research Site | Cincinnati, Ohio, United States |
| Research Site | Cleveland, Ohio, United States |
| Research Site | Dayton, Ohio, United States |
| Research Site | Willoughby, Ohio, United States |
| Research Site | Oklahoma City, Oklahoma, United States |
| Research Site | Eugene, Oregon, United States |
| Research Site | Salem, Oregon, United States |
| Research Site | Allentown, Pennsylvania, United States |
| Research Site | Philadelphia, Pennsylvania, United States |
| Research Site | Charleston, South Carolina, United States |
| Research Site | Bartlett, Tennessee, United States |
| Research Site | Austin, Texas, United States |
| Research Site | Dallas, Texas, United States |
| Research Site | San Antonio, Texas, United States |
| Research Site | Wichita Falls, Texas, United States |
| Research Site | Richmond, Virginia, United States |
| Research Site | Seattle, Washington, United States |