Status:
COMPLETED
Pregabalin in the Treatment of Patients With Generalized Anxiety Disorder (GAD).
Lead Sponsor:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Conditions:
Generalized Anxiety Disorder
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The primary objective of this study is to evaluate the efficacy of pregabalin as compared to placebo in the treatment of patients with general anxiety disorder (GAD). Efficacy will be measured by the ...
Detailed Description
Further enrollment in this study was stopped on January 28, 2008 based on the recommendation of an independent data monitoring committee. The recommendation to stop the study was not based on any safe...
Eligibility Criteria
Inclusion
- Adult male and female subjects with primary DSM-IV diagnosis of GAD, as confirmed by the MINI structured interview.
- Historical failure to respond optimally to a GAD treatment
Exclusion
- Current primary DSM-IV (Diagnostic and Statistical Manual of Mental Disorders 4th edition) diagnosis of major depressive disorder with or without seasonal pattern, dysthmic disorder, depressive disorder NOS (not otherwise specified), social phobia, panic disorder with or without agoraphobia, post traumatic stress disorder, dissociative disorder, borderline personality disorder, obsessive-compulsive disorder, antisocial personality disorder, as defined in the DSM-IV TR (Diagnostic and Statistical Manual of Mental Disorders 4th edition, Text Revision).
- Past and/or current DSM-IV diagnosis of schizophrenia, schizoaffective disorder, other psychotic disorders, bipolar disorders (I or II), factitious disorder or cognitive disorder (including delirium, dementia, and amnestic disorder).
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2008
Estimated Enrollment :
356 Patients enrolled
Trial Details
Trial ID
NCT00413010
Start Date
December 1 2006
End Date
March 1 2008
Last Update
February 10 2021
Active Locations (68)
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1
Pfizer Investigational Site
Arcadia, California, United States, 91007-3462
2
Pfizer Investigational Site
Burbank, California, United States, 91506
3
Pfizer Investigational Site
Redlands, California, United States, 92374
4
Pfizer Investigational Site
Sherman Oaks, California, United States, 91403