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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.
First Received: August 23, 2006   Last Updated: November 11, 2008   History of Changes
Sponsored by: Pfizer
Information provided by: Pfizer
ClinicalTrials.gov Identifier: NCT00368745
  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 pregablin 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 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.


Condition Intervention Phase
Generalized Anxiety Disorder
 Drug: Pregablin
Other: Placebo
 Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
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:

MedlinePlus related topics: Anxiety
Drug Information available for: Pregabalin
U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Negative benzodiazepine use defined as negative labs for benzodiazepines as well not requiring use of 'rescue' alprazolam packet between visits [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
  • 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). [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. [ Time Frame: weeks 0, 6-13 ] [ Designated as safety issue: Yes ]
  • 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) [ Time Frame: weeks 6-13 ] [ Designated as safety issue: No ]
  • Mean 'Patient Global Impression-Improvement' (PGI-I) score at each visit. [ Time Frame: week 1-13 ] [ Designated as safety issue: No ]
  • Mean Clinician Global Impression-Improvement (CGI-I) score at each visit. [ Time Frame: weeks 1-13 ] [ Designated as safety issue: No ]
  • 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. [ Time Frame: weeks 0, 6-13 ] [ Designated as safety issue: Yes ]
  • Time until first subject needs to take "rescue medication" [ Time Frame: days 1-91 ] [ Designated as safety issue: Yes ]
  • Mean change in weekly 'Physician Withdrawal Checklist' (PWC) scores compared to randomization /baseline [ Time Frame: weeks 0-13 ] [ Designated as safety issue: Yes ]
  • Mean change from randomization /baseline to endpoint in 'Digit Symbol Substitution Test'(DSST) scores [ Time Frame: week 0, 13 ] [ Designated as safety issue: No ]
  • Mean change in weekly anxiety scores compared to baseline (measured by Hamilton Anxiety Scale or HAM-A) [ Time Frame: weeks 0-13 ] [ Designated as safety issue: No ]
  • Time until subject discontinuation (inability to tolerate benzodiazepine taper or free state) [ Time Frame: days 1-91 ] [ Designated as safety issue: Yes ]
  • Mean change between 'randomization/baseline' score of Clinical Global Impression Severity (CGI-S) and weekly scores of CGI-S. [ Time Frame: weeks 0-13 ] [ Designated as safety issue: No ]

Enrollment: 114
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
Pregabalin: Active Comparator
Pregabalin treatment for GAD during 6 week taper/discontinuation from alprazolam treatment; followed by 6 weeks pregabalin treatment 'alprazolam free'.
Drug: Pregablin
GAD subjects on stable dose of alprazolam will be randomized to pregabalin vs matching placebo 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 vs placebo at dose range between 75 and 300 twice daily. Subjects successful in discontinuation of alprazolam while treated with placebo vs pregabalin will continue to be maintained on their randomized medication for 6 weeks and assessed weekly for ability to remain
Treatment: Placebo Comparator
Placebo treatment of GAD during 6 week taper/discontinuation of alprazolam treatment followed by 6 weeks continuation of placebo treatment 'alprazolam free'.
Other: Placebo
GAD subjects on stable dose of alprazolam will be randomized to pregabalin vs matching placebo 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 vs placebo at dose range between 75 and 300 twice daily. Subjects successful in discontinuation of alprazolam while treated with placebo vs pregabalin will continue to be maintained on their randomized medication for 6 weeks and assessed weekly for ability to remain

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

Locations
Costa Rica, San José
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 7, Czech Republic, 170 00
Pfizer Investigational Site
Praha-Bubenec, Czech Republic, 170 00
Pfizer Investigational Site
Praha 6, Czech Republic, 163 00
Pfizer Investigational Site
Praha 10, Czech Republic, 100 00
France
Pfizer Investigational Site
Elancourt, France, 78990
Pfizer Investigational Site
Nantes-Orvault, France, 44700
Pfizer Investigational Site
ARCACHON, France, 33120
Pfizer Investigational Site
Caen, France, 14000
France, Cedex 12
Pfizer Investigational Site
Paris, Cedex 12, France, 75571
Guatemala
Pfizer Investigational Site
Guatemala, Guatemala
Italy
Pfizer Investigational Site
20157 Milano, Italy, 20157
Pfizer Investigational Site
L'Aquila, Italy, 67100
Mexico
Pfizer Investigational Site
Mexico D.F., Mexico, 03740
Pfizer Investigational Site
San Luis Potosi, Mexico, 78216
Mexico, Nayarit
Pfizer Investigational Site
Tepic, Nayarit, Mexico, 63000
Spain
Pfizer Investigational Site
BARCELONA, Spain, 08036
Pfizer Investigational Site
BARCELONA, Spain, 08025
Pfizer Investigational Site
ZAMORA, Spain, 49021
Spain, ASTURIAS
Pfizer Investigational Site
LANGREO, ASTURIAS, Spain, 33900
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers: A0081092
Study First Received: August 23, 2006
Last Updated: November 11, 2008
ClinicalTrials.gov Identifier: NCT00368745     History of Changes
Health Authority: Mexico: Secretaria de Salud de Mexico

Study placed in the following topic categories:
Alprazolam
Anxiety Disorders
Mental Disorders
Pregabalin
 Peripheral Nervous System Agents
Analgesics
Anticonvulsants

Additional relevant MeSH terms:
Disease
Physiological Effects of Drugs
Pregabalin
Pharmacologic Actions
Pathologic Processes
Anxiety Disorders
Mental Disorders
 Sensory System Agents
Therapeutic Uses
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents
Anticonvulsants

ClinicalTrials.gov processed this record on August 12, 2009



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