Safety and Efficacy Evaluation Of Pregabalin (Lyrica) With Patients With Generalized Anxiety Disorder

• Drug: Pregabalin
  
  Pregabalin 150-300 mg given twice a day
  Other Name: Lyrica
• Drug: Lorazepam
  
  Lorazepam 3-4 mg given twice a day
• Drug: Pregabalin
  
  Pregabalin 450-600 mg given twice a day
  Other Name: Lyrica
• Drug: Placebo
  
  Placebo

• Experimental: 1
  
  Intervention: Drug: Pregabalin
• Active Comparator: 2
  
  Intervention: Drug: Lorazepam
• Experimental: 3
  
  Intervention: Drug: Pregabalin
• Placebo Comparator: 4
  
  Intervention: Drug: Placebo

Inclusion Criteria:

• Diagnosis Generalized Anxiety Disorder
• HAM-A score >=18 and HAM-D (item 1) score >=2 at screening and baseline
• Needs pharmacological treatment

Exclusion Criteria:

• Current or past diagnosis of any other DSM IV Axis I disorders
• A history of failed treatment with a benzodiazepine
• Any clinically significant, serious, or unstable hematologic, autoimmune, endocrine, cardiovascular, renal, hepatic, gastrointestinal, or neurological disorder