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.

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

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.

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) Scores

Number 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)

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

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

To obtain contact information for a study center near you, click here.

Starting date: September 2006
Last updated: November 9, 2009