Status:
COMPLETED
Efficacy and Safety of Pregabalin vs Placebo for Generalized Anxiety Disorder (GAD) Symptoms in Subjects Discontinuing Benzodiazepine Treatment and Remaining 6 Weeks on Study Medication, Free From Benzodiazepine Use.
Lead Sponsor:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Conditions:
Generalized Anxiety Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
GAD subjects maintained on a stable dose of alprazolam for at least four weeks who meet eligibility criteria will be randomized to receive pregabalin vs matching placebo while simultaneously tapering ...
Eligibility Criteria
Inclusion
- Provide written informed consent
- 18-65 years old
- male and female
- A primary lifetime diagnosis of DSM-IV-TR (2000) GAD (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition)
Exclusion
- Pregnant or lactating women
- History of non-response to alprazolam, other benzodiazepines, gabapentin or pregabalin given for the treatment of anxiety as indicated by a (screening or baseline) Hamilton Anxiety Scale (HAM-A) score \> 18
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2008
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT00368745
Start Date
September 1 2006
End Date
August 1 2008
Last Update
February 9 2021
Active Locations (21)
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1
Pfizer Investigational Site
San Pedro, Provincia de San José, Costa Rica, 00
2
Pfizer Investigational Site
Pilsen, Czechia, 301 00
3
Pfizer Investigational Site
Prague, Czechia, 100 00
4
Pfizer Investigational Site
Prague, Czechia, 163 00