Safety and Efficacy Evaluation Of Pregabalin (Lyrica) With Patients With Generalized Anxiety Disorder
NCT00624780
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
- Diagnosis Generalized Anxiety Disorder
- HAM-A score >=18 and HAM-D (item 1) score >=2 at screening and baseline
- Needs pharmacological treatment
- Current or past diagnosis of any other DSM IV Axis I disorders
- A history of failed treatment with a benzodiazepine
- Any clinically significant, serious, or unstable hematologic, autoimmune, endocrine,
cardiovascular, renal, hepatic, gastrointestinal, or neurological disorder
NEED INFO?
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

TRY A NEW SEARCH
Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Based on your search, you may also be interested in
- New Haven, Connecticut
- New Haven, Connecticut
- Orlando, Florida
- Prairie Village, Kansas
- Birmingham, Alabama
- Litchfield Park, Arizona
- Arcadia, California
- Beverly Hills, California
- Costa Mesa, California
- Costa Mesa, California
- Encino, California
- Escondido, California
- Murrieta, California
- National City, California
- Newport Beach, California
- Orange, California
- Pasadena, California
- Redlands, California
- San Diego, California
- San Diego, California
- Sherman Oaks, California
- Temecula, California
- Upland, California
- Wildomar, California
- Denver, Colorado
- Hamden, Connecticut
- Norwich, Connecticut
- Altamonte Springs, Florida
- Ft. Myers, Florida
- Jacksonville, Florida
- Maitland, Florida
- Miami, Florida
- Miami, Florida
- Orange City, Florida
- Orlando, Florida
- South Miami, Florida
- West Palm Beach, Florida
- Atlanta, Georgia
- Atlanta, Georgia
- Marietta, Georgia
- Libertyville, Illinois
- Naperville, Illinois
- Park Ridge, Illinois
- Greenwood, Indiana
- Terre Haute, Indiana
- Overland Park, Kansas
- Prairie Village, Kansas
- Wichita, Kansas
- Owensboro, Kentucky
- Lake Charles, Louisiana
- Baltimore, Maryland
- Belmont, Massachusetts
- Boston, Massachusetts
- Fall River, Massachusetts
- Haverhill, Massachusetts
- Pittsfield, Massachusetts
- Omaha, Nebraska
- Las Vegas, Nevada
- Nashua, New Hampshire
- Albuquerque, New Mexico
- Bronx, New York
- Brooklyn, New York
- New York, New York
- New York, New York
- New York, New York
- Rochester, New York
- Raleigh, North Carolina
- Columbus, Ohio
- Dayton, Ohio
- Toledo, Ohio
- Toledo, Ohio
- Bethany, Oklahoma
- Oklahoma City, Oklahoma
- Oklahoma City, Oklahoma
- Portland, Oregon
- Salem, Oregon
- Allentown, Pennsylvania
- Media, Pennsylvania
- Norristown, Pennsylvania
- Philadelphia, Pennsylvania
- Lincoln, Rhode Island
- Columbia, South Carolina
- Memphis, Tennessee
- Memphis, Tennessee
- Austin, Texas
- Dallas, Texas
- Dallas, Texas
- DeSoto, Texas
- Houston, Texas
- Houston, Texas
- Lake Jackson, Texas
- San Antonio, Texas
- Woodstock, Vermont
- Charlottesville, Virginia
- Seattle, Washington
- Middleton, Wisconsin
- Waukesha, Wisconsin
Descriptive Information | ||||
---|---|---|---|---|
Brief Title ICMJE | Safety and Efficacy Evaluation Of Pregabalin (Lyrica) With Patients With Generalized Anxiety Disorder | |||
Official Title ICMJE | Long Term Safety And Efficacy Study Of Pregabalin (Lyrica) In Subjects With Generalized Anxiety Disorder | |||
Brief Summary | The purpose of this study is to characterize the safety and efficacy in patients with generalized anxiety disorder after short- (3 months) and long-term (6 months) use of Pregabalin (Lyrica). | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 4 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment | |||
Condition ICMJE | Generalized Anxiety Disorder | |||
Intervention ICMJE |
| |||
Study Arms ICMJE |
| |||
Publications * | Kasper S, Iglesias-García C, Schweizer E, Wilson J, DuBrava S, Prieto R, Pitman VW, Knapp L. Pregabalin long-term treatment and assessment of discontinuation in patients with generalized anxiety disorder. Int J Neuropsychopharmacol. 2014 May;17(5):685-95. doi: 10.1017/S1461145713001557. Epub 2013 Dec 19. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 615 | |||
Original Estimated Enrollment ICMJE | 600 | |||
Actual Study Completion Date ICMJE | April 2012 | |||
Actual Primary Completion Date | April 2012 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | 18 Years to 65 Years (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Argentina, Austria, Costa Rica, Croatia, Czechia, Finland, Greece, India, Indonesia, Lithuania, Mexico, Russian Federation, Serbia, Slovenia, Spain, Turkey | |||
Removed Location Countries | Colombia, Czech Republic | |||
Administrative Information | ||||
NCT Number ICMJE | NCT00624780 | |||
Other Study ID Numbers ICMJE | A0081147 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. ) | |||
Study Sponsor ICMJE | Pfizer's Upjohn has merged with Mylan to form Viatris Inc. | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
| |||
PRS Account | Pfizer | |||
Verification Date | September 2012 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |