Clinical trial 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.
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Pregabalin in Subjects With Generalized Anxiety Disorder (GAD) Switching From Benzodiazepine Therapy.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Generalized Anxiety Disorder
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2006-08-25
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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

Primary outcomes:
measure: 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
timeFrame: Endpoint (Post Alprazolam Free Week 6 or LOCF Post Alprazolam Free Week 1)
Secondary outcomes:
measure: Mean Change From Baseline in Hamilton Anxiety Scale (HAM-A) Scores
timeFrame: Baseline, Alprazolam Taper Weeks 1 through 6, Alprazolam Free Weeks 1 through 6, and Endpoint (Alprazolam Free [AF] Week 6)
measure: Number of Subjects With > = 6 Point Increase in Physician's Withdrawal Checklist (PWC) Scores
timeFrame: Baseline, Alprazolam Free Weeks 1 through 6, Endpoint (AF Week 6)
measure: Number of Subjects With > = 5 New PWC Symptoms
timeFrame: Baseline, Alprazolam Free Weeks 1 through 6, Endpoint (AF Week 6)
measure: Mean Change From Baseline in Physician's Withdrawal Checklist (PWC) Scores
timeFrame: Baseline, Alprazolam Taper Weeks 1 through 6, Alprazolam Free Weeks 1 through 6, Endpoint (AF Week 6)
measure: Mean Change From Baseline in Clinical Global Impression Severity (CGI-S) Scale Scores.
timeFrame: Baseline, Alprazolam Taper Weeks 1 through 6, Alprazolam Free Weeks 1 through 6, and Endpoint (AF Week 6 )
measure: Mean Scores for Clinical Global Impression-Improvement (CGI-I) Scale
timeFrame: Alprazolam Taper Weeks 1 through 6, Alprazolam Free Weeks 1 through 6, and Endpoint (AF Week 6 )
measure: Mean Scores for Patient Global Impression-Improvement (PGI-I)
timeFrame: Alprazolam Taper Weeks 1 through 6, Alprazolam Free Weeks 1 through 6, and Endpoint (AF Week 6 )
measure: Mean Change From Baseline in Digit Symbol Substitution Test (DSST) Scores
timeFrame: Baseline, Endpoint (AF Week 6 )
measure: Time to Discontinuation
timeFrame: Baseline, Week 13 (Final Visit/Early Termination)
measure: Time to First Use of Rescue Medication
timeFrame: Baseline, Week 13 (Final Visit/Early Termination)
measure: Number of Subjects in Relapse Free State at 6-week Benzodiazepine-free Endpoint (Alprazolam Free Week 6)
timeFrame: Alprazolam Free Week 6
Other outcomes:
Locations:
city: San Pedro De Montes De Oca
country: Costa Rica
facility: Pfizer Investigational Site
state: San José
city: Plzen
country: Czechia
facility: Pfizer Investigational Site
city: Praha 10
country: Czechia
facility: Pfizer Investigational Site
city: Praha 6
country: Czechia
facility: Pfizer Investigational Site
city: Praha 7
country: Czechia
facility: Pfizer Investigational Site
city: Praha-Bubenec
country: Czechia
facility: Pfizer Investigational Site
city: Paris
country: France
facility: Pfizer Investigational Site
state: Cedex 12
city: Arcachon
country: France
facility: Pfizer Investigational Site
city: Caen
country: France
facility: Pfizer Investigational Site
city: Elancourt
country: France
facility: Pfizer Investigational Site
city: Nantes-Orvault
country: France
facility: Pfizer Investigational Site
city: Guatemala
country: Guatemala
facility: Pfizer Investigational Site
city: L'Aquila
country: Italy
facility: Pfizer Investigational Site
city: Milan
country: Italy
facility: Pfizer Investigational Site
city: Tepic
country: Mexico
facility: Pfizer Investigational Site
state: Nayarit
city: Mexico D.F.
country: Mexico
facility: Pfizer Investigational Site
city: San Luis Potosi
country: Mexico
facility: Pfizer Investigational Site
city: Langreo
country: Spain
facility: Pfizer Investigational Site
state: Asturias
city: Barcelona
country: Spain
facility: Pfizer Investigational Site
city: Barcelona
country: Spain
facility: Pfizer Investigational Site
city: Zamora
country: Spain
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: