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.
NCT ID: NCT00368745
Last Updated: 2021-02-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
108 participants
INTERVENTIONAL
2006-09-30
2008-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Pregabalin
Pregabalin treatment for GAD during 6 week taper/discontinuation from alprazolam treatment; followed by 6 weeks pregabalin treatment 'alprazolam free'.
Pregabalin
GAD subjects on stable dose of alprazolam will be randomized to double-blind pregabalin at starting dose of 75mg twice daily. Weekly assessments of tolerability, need for rescue medication, anxiety/withdrawal symptoms will guide flexible dose titration of pregabalin at dose range between 75 and 300mg twice daily. Subjects successful in discontinuation of alprazolam while treated with pregabalin will continue to be maintained on pregabalin for 6 weeks and assessed weekly for ability to remain in the study.
Placebo
Placebo treatment of GAD during 6 week taper/discontinuation of alprazolam treatment followed by 6 weeks continuation of placebo treatment 'alprazolam free'.
Placebo
GAD subjects on stable dose of alprazolam will be randomized to double-blind placebo matching assessments and study medication titration as detailed under the pregabalin arm description. Subjects successful in discontinuation of alprazolam while treated with placebo will continue to be maintained on placebo for 6 weeks and assessed weekly for ability to remain in the study.
Interventions
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Pregabalin
GAD subjects on stable dose of alprazolam will be randomized to double-blind pregabalin at starting dose of 75mg twice daily. Weekly assessments of tolerability, need for rescue medication, anxiety/withdrawal symptoms will guide flexible dose titration of pregabalin at dose range between 75 and 300mg twice daily. Subjects successful in discontinuation of alprazolam while treated with pregabalin will continue to be maintained on pregabalin for 6 weeks and assessed weekly for ability to remain in the study.
Placebo
GAD subjects on stable dose of alprazolam will be randomized to double-blind placebo matching assessments and study medication titration as detailed under the pregabalin arm description. Subjects successful in discontinuation of alprazolam while treated with placebo will continue to be maintained on placebo for 6 weeks and assessed weekly for ability to remain in the study.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
65 Years
ALL
No
Sponsors
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Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Pfizer Investigational Site
San Pedro, Provincia de San José, Costa Rica
Pfizer Investigational Site
Pilsen, , Czechia
Pfizer Investigational Site
Prague, , Czechia
Pfizer Investigational Site
Prague, , Czechia
Pfizer Investigational Site
Prague, , Czechia
Pfizer Investigational Site
Praha-Bubenec, , Czechia
Pfizer Investigational Site
Paris, Cedex 12, France
Pfizer Investigational Site
Arcachon, , France
Pfizer Investigational Site
Caen, , France
Pfizer Investigational Site
Élancourt, , France
Pfizer Investigational Site
Nantes-Orvault, , France
Pfizer Investigational Site
Guatemala City, , Guatemala
Pfizer Investigational Site
L’Aquila, , Italy
Pfizer Investigational Site
Milan, , Italy
Pfizer Investigational Site
Tepic, Nayarit, Mexico
Pfizer Investigational Site
Mexico City, , Mexico
Pfizer Investigational Site
San Luis Potosí City, , Mexico
Pfizer Investigational Site
Langreo, Principality of Asturias, Spain
Pfizer Investigational Site
Barcelona, , Spain
Pfizer Investigational Site
Barcelona, , Spain
Pfizer Investigational Site
Zamora, , Spain
Countries
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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A0081092
Identifier Type: -
Identifier Source: org_study_id
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