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: Generalized Anxiety Disorder
MeSH terms: Anxiety Disorders
Intervention: Pregabalin; Placebo
Intervention description: 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.; 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.
Intervention MeSH terms: Pregabalin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 108.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

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