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.
Information source: Pfizer
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Generalized Anxiety Disorder
Intervention: Pregablin (Drug); Placebo (Other)
Phase: Phase 3
Sponsored by: Pfizer
Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer
Pfizer CT.gov Call Center, Phone: 1-800-718-1021
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 off of alprazolam over 6 weeks. Subjects return weekly for assessment
of safety/tolerability of pregablin vs placebo as well as for assessment of anxiety and
benzodiazepine withdrawal symptoms. Subjects sucessfully able to discontinue alprazolam, will
continue 6 weeks of treatment with pregabalin vs placebo (free of benzodiazepine use). The
efficacy and safety of pregablin vs placebo for anxiety symptoms and ability to
discontinue/remain free of alprazolam will be compared among pregablin and placebo treated
groups. Hypothesis is that a greater proportion of subjects will be successful in
discontinuing and remaining free from benzodiazepines who were treated with pregabalin as
compared to subjects treated with placebo.
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Pregabalin in Subjects With Generalized Anxiety Disorder (GAD) Switching From Benzodiazepine Therapy.
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Negative urine benzodiazepine/psychoactive toxicology assay (done at each visit of the Alprazolam-Free Phase of Double-Blind Treatment) and negative serum benzodiazepine/alcohol assay (done at endpoint).
Negative benzodiazepine use defined as negative labs for benzodiazepines as well not requiring use of 'rescue' alprazolam packet between visits
Efficacy/Safety: Following taper and discontinuation from stable benzodiazepine treatment,the proportion of subjects treated with pregabalin who remain 6 weeks free from benzodiazepine use compared to subjects treated with placebo.
Mean change between 'randomization/baseline' score of Clinical Global Impression Severity (CGI-S) and weekly scores of CGI-S.
Proportion of subjects with > 6 point increase in PWC scores compared to baseline or compared to a previous week in the 6 week benzodiazepine free period.
Proportion of subjects with > 5 new PWC symptoms between weekly visits during the benzodiazepine free 6 week period or between a weekly visit and baseline visit.
Amount of time 'relapse free' among treatment groups during 6 week 'benzodiazepine free'phase (Relapse free-defined as negative labs for benzodiazepines and not requiring more than allowed rescue benzodiazepine medication between visits)
Mean 'Patient Global Impression-Improvement' (PGI-I) score at each visit.
Mean Clinician Global Impression-Improvement (CGI-I) score at each visit.
Time until first subject needs to take "rescue medication"
Mean change in weekly 'Physician Withdrawal Checklist' (PWC) scores compared to randomization /baseline
Mean change from randomization /baseline to endpoint in 'Digit Symbol Substitution Test'(DSST) scores
Mean change in weekly anxiety scores compared to baseline (measured by Hamilton Anxiety Scale or HAM-A)
Time until subject discontinuation (inability to tolerate benzodiazepine taper or free state)
Minimum age: 18 Years.
Maximum age: 65 Years.
- 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)
- Pregnant or lactating women
- History of non-response to alprazolam, other benzodiazepines, gabapentine or
pregabalin given for the treatment of anxiety as indicated by a (screening or
baseline) Hamilton Anxiety Scale (HAM-A) score > 18
Locations and Contacts
Pfizer CT.gov Call Center, Phone: 1-800-718-1021
Pfizer Investigational Site, Plzen 301 00, Czech Republic; Completed
Pfizer Investigational Site, Praha 7 170 00, Czech Republic; Completed
Pfizer Investigational Site, Praha-Bubenec 170 00, Czech Republic; Completed
Pfizer Investigational Site, Praha 6 163 00, Czech Republic; Recruiting
Pfizer Investigational Site, Praha 10 - Hostivar 102 00, Czech Republic; Completed
Pfizer Investigational Site, Elancourt 78990, France; Completed
Pfizer Investigational Site, Nantes-Orvault 44700, France; Completed
Pfizer Investigational Site, ARCACHON 33120, France; Completed
Pfizer Investigational Site, Caen 14000, France; Completed
Pfizer Investigational Site, Guatemala, Guatemala; Active, not recruiting
Pfizer Investigational Site, 20157 Milano 20157, Italy; Completed
Pfizer Investigational Site, L'Aquila 67100, Italy; Active, not recruiting
Pfizer Investigational Site, Mexico D.F. 03740, Mexico; Completed
Pfizer Investigational Site, San Luis Potosi 78216, Mexico; Active, not recruiting
Pfizer Investigational Site, BARCELONA 08036, Spain; Active, not recruiting
Pfizer Investigational Site, BARCELONA 08025, Spain; Completed
Pfizer Investigational Site, ZAMORA 49021, Spain; Completed
Pfizer Investigational Site, LANGREO, ASTURIAS 33900, Spain; Completed
Pfizer Investigational Site, Paris, Cedex 12 75571, France; Completed
Pfizer Investigational Site, Tepic, Nayarit 63000, Mexico; Active, not recruiting
Pfizer Investigational Site, San Pedro de Montes de Oca, San José 00, Costa Rica; Completed
To obtain contact information for a study center near you, click here.
Starting date: September 2006
Ending date: September 2008
Last updated: October 9, 2008