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.

PHASE3CompletedINTERVENTIONAL
Enrollment

108

Participants

Timeline

Start Date

September 30, 2006

Primary Completion Date

August 31, 2008

Study Completion Date

August 31, 2008

Conditions
Generalized Anxiety Disorder
Interventions
DRUG

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.

DRUG

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.

Trial Locations (21)

14000

Pfizer Investigational Site, Caen

20157

Pfizer Investigational Site, Milan

33120

Pfizer Investigational Site, Arcachon

33900

Pfizer Investigational Site, Langreo

44700

Pfizer Investigational Site, Nantes-Orvault

49021

Pfizer Investigational Site, Zamora

63000

Pfizer Investigational Site, Tepic

67100

Pfizer Investigational Site, L’Aquila

75571

Pfizer Investigational Site, Paris

78216

Pfizer Investigational Site, San Luis Potosí City

78990

Pfizer Investigational Site, Élancourt

00

Pfizer Investigational Site, San Pedro

301 00

Pfizer Investigational Site, Pilsen

100 00

Pfizer Investigational Site, Prague

163 00

Pfizer Investigational Site, Prague

170 00

Pfizer Investigational Site, Prague

Pfizer Investigational Site, Praha-Bubenec

Unknown

Pfizer Investigational Site, Guatemala City

03740

Pfizer Investigational Site, Mexico City

08025

Pfizer Investigational Site, Barcelona

08036

Pfizer Investigational Site, Barcelona

All Listed Sponsors
lead

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

INDUSTRY

NCT00368745 - 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. | Biotech Hunter | Biotech Hunter