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
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Generalized Anxiety Disorder
Intervention: Pregabalin (Drug); Placebo (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Pfizer Official(s) and/or principal investigator(s): Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer
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 off of alprazolam over 6 weeks. Subjects return weekly for
assessment of safety/tolerability of pregabalin vs placebo as well as for assessment of
anxiety and benzodiazepine withdrawal symptoms. Subjects successfully able to discontinue
alprazolam, will continue 6 weeks of treatment with pregabalin vs placebo (free of
benzodiazepine use). The efficacy and safety of pregabalin vs placebo for anxiety symptoms
and ability to discontinue/remain free of alprazolam will be compared among pregabalin 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.
Clinical Details
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: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Number of Subjects at Endpoint (Post Alprazolam Free Week 6 or Last Observation Carried Forward [LOCF] Post Alprazolam Free Week 1) Who Are Benzodiazepine Free
Secondary outcome: Mean Change From Baseline in Hamilton Anxiety Scale (HAM-A) ScoresNumber of Subjects With > = 6 Point Increase in Physician's Withdrawal Checklist (PWC) Scores Number of Subjects With > = 5 New PWC Symptoms Mean Change From Baseline in Physician's Withdrawal Checklist (PWC) Scores Mean Change From Baseline in Clinical Global Impression Severity (CGI-S) Scale Scores. Mean Scores for Clinical Global Impression-Improvement (CGI-I) Scale Mean Scores for Patient Global Impression-Improvement (PGI-I) Mean Change From Baseline in Digit Symbol Substitution Test (DSST) Scores Time to Discontinuation Time to First Use of Rescue Medication Number of Subjects in Relapse Free State at 6-week Benzodiazepine-free Endpoint (Alprazolam Free Week 6)
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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 Criteria:
- 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
Locations and Contacts
Pfizer Investigational Site, Plzen 301 00, Czech Republic
Pfizer Investigational Site, Praha 10 100 00, Czech Republic
Pfizer Investigational Site, Praha 6 163 00, Czech Republic
Pfizer Investigational Site, Praha 7 170 00, Czech Republic
Pfizer Investigational Site, Praha-Bubenec 170 00, Czech Republic
Pfizer Investigational Site, Arcachon 33120, France
Pfizer Investigational Site, Caen 14000, France
Pfizer Investigational Site, Elancourt 78990, France
Pfizer Investigational Site, Nantes-Orvault 44700, France
Pfizer Investigational Site, Guatemala, Guatemala
Pfizer Investigational Site, L'Aquila 67100, Italy
Pfizer Investigational Site, Milan 20157, Italy
Pfizer Investigational Site, Mexico D.f. 03740, Mexico
Pfizer Investigational Site, San Luis Potosi 78216, Mexico
Pfizer Investigational Site, Barcelona 08025, Spain
Pfizer Investigational Site, Barcelona 08036, Spain
Pfizer Investigational Site, Zamora 49021, Spain
Pfizer Investigational Site, Langreo, Asturias 33900, Spain
Pfizer Investigational Site, Paris, Cedex 12 75571, France
Pfizer Investigational Site, Tepic, Nayarit 63000, Mexico
Pfizer Investigational Site, San Pedro de Montes de Oca, San José 00, Costa Rica
Additional Information
To obtain contact information for a study center near you, click here.
Starting date: September 2006
Last updated: November 9, 2009
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