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.

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00368745
First received: August 23, 2006
Last updated: November 9, 2009
Last verified: November 2009
  Purpose

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.


Condition Intervention Phase
Generalized Anxiety Disorder
Drug: Pregabalin
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Pregabalin in Subjects With Generalized Anxiety Disorder (GAD) Switching From Benzodiazepine Therapy.

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 [ Time Frame: Endpoint (Post Alprazolam Free Week 6 or LOCF Post Alprazolam Free Week 1) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mean Change From Baseline in Hamilton Anxiety Scale (HAM-A) Scores [ Time Frame: Baseline, Alprazolam Taper Weeks 1 through 6, Alprazolam Free Weeks 1 through 6, and Endpoint (Alprazolam Free [AF] Week 6) ] [ Designated as safety issue: No ]
  • Number of Subjects With > = 6 Point Increase in Physician's Withdrawal Checklist (PWC) Scores [ Time Frame: Baseline, Alprazolam Free Weeks 1 through 6, Endpoint (AF Week 6) ] [ Designated as safety issue: No ]
  • Number of Subjects With > = 5 New PWC Symptoms [ Time Frame: Baseline, Alprazolam Free Weeks 1 through 6, Endpoint (AF Week 6) ] [ Designated as safety issue: No ]
  • Mean Change From Baseline in Physician's Withdrawal Checklist (PWC) Scores [ Time Frame: Baseline, Alprazolam Taper Weeks 1 through 6, Alprazolam Free Weeks 1 through 6, Endpoint (AF Week 6) ] [ Designated as safety issue: No ]
  • Mean Change From Baseline in Clinical Global Impression Severity (CGI-S) Scale Scores. [ Time Frame: Baseline, Alprazolam Taper Weeks 1 through 6, Alprazolam Free Weeks 1 through 6, and Endpoint (AF Week 6 ) ] [ Designated as safety issue: No ]
  • Mean Scores for Clinical Global Impression-Improvement (CGI-I) Scale [ Time Frame: Alprazolam Taper Weeks 1 through 6, Alprazolam Free Weeks 1 through 6, and Endpoint (AF Week 6 ) ] [ Designated as safety issue: No ]
  • Mean Scores for Patient Global Impression-Improvement (PGI-I) [ Time Frame: Alprazolam Taper Weeks 1 through 6, Alprazolam Free Weeks 1 through 6, and Endpoint (AF Week 6 ) ] [ Designated as safety issue: No ]
  • Mean Change From Baseline in Digit Symbol Substitution Test (DSST) Scores [ Time Frame: Baseline, Endpoint (AF Week 6 ) ] [ Designated as safety issue: No ]
  • Time to Discontinuation [ Time Frame: Baseline, Week 13 (Final Visit/Early Termination) ] [ Designated as safety issue: Yes ]
  • Time to First Use of Rescue Medication [ Time Frame: Baseline, Week 13 (Final Visit/Early Termination) ] [ Designated as safety issue: Yes ]
  • Number of Subjects in Relapse Free State at 6-week Benzodiazepine-free Endpoint (Alprazolam Free Week 6) [ Time Frame: Alprazolam Free Week 6 ] [ Designated as safety issue: No ]

Enrollment: 108
Study Start Date: September 2006
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Pregabalin
Pregabalin treatment for GAD during 6 week taper/discontinuation from alprazolam treatment; followed by 6 weeks pregabalin treatment 'alprazolam free'.
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.
Other Name: Lyrica
Placebo Comparator: Placebo
Placebo treatment of GAD during 6 week taper/discontinuation of alprazolam treatment followed by 6 weeks continuation of placebo treatment 'alprazolam free'.
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00368745

Locations
Costa Rica
Pfizer Investigational Site
San Pedro de Montes de Oca, San José, Costa Rica, 00
Czech Republic
Pfizer Investigational Site
Plzen, Czech Republic, 301 00
Pfizer Investigational Site
Praha 10, Czech Republic, 100 00
Pfizer Investigational Site
Praha 6, Czech Republic, 163 00
Pfizer Investigational Site
Praha 7, Czech Republic, 170 00
Pfizer Investigational Site
Praha-Bubenec, Czech Republic, 170 00
France
Pfizer Investigational Site
Paris, Cedex 12, France, 75571
Pfizer Investigational Site
Arcachon, France, 33120
Pfizer Investigational Site
Caen, France, 14000
Pfizer Investigational Site
Elancourt, France, 78990
Pfizer Investigational Site
Nantes-Orvault, France, 44700
Guatemala
Pfizer Investigational Site
Guatemala, Guatemala
Italy
Pfizer Investigational Site
L'Aquila, Italy, 67100
Pfizer Investigational Site
Milan, Italy, 20157
Mexico
Pfizer Investigational Site
Tepic, Nayarit, Mexico, 63000
Pfizer Investigational Site
Mexico D.f., Mexico, 03740
Pfizer Investigational Site
San Luis Potosi, Mexico, 78216
Spain
Pfizer Investigational Site
Langreo, Asturias, Spain, 33900
Pfizer Investigational Site
Barcelona, Spain, 08036
Pfizer Investigational Site
Barcelona, Spain, 08025
Pfizer Investigational Site
Zamora, Spain, 49021
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00368745     History of Changes
Other Study ID Numbers: A0081092
Study First Received: August 23, 2006
Results First Received: August 10, 2009
Last Updated: November 9, 2009
Health Authority: Mexico: Secretaria de Salud de Mexico

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders
Alprazolam
Pregabalin
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Cardiovascular Agents

ClinicalTrials.gov processed this record on August 21, 2014