Clinical Study Assessing a New Scale to Measure Onset of Action in Generalized Anxiety Disorder

• Drug: lorazepam
  1.0 mg p.o. three times a day for three days, then 1.5mg p.o. three times a day for 25 days
  Other Name: Ativan
• Drug: placebo
  placebo p.o. t.i.d. for 28 days; placebo matching lorazepam and paroxetine
• Drug: paroxetine
  20mg p.o. daily for 28 days; and matching placebo twice a day to maintain blind
  Other Name: Paxil

• Active Comparator: lorazepam
  Intervention: Drug: lorazepam
• Placebo Comparator: placebo
  Intervention: Drug: placebo
• Active Comparator: paroxetine
  Intervention: Drug: paroxetine

Inclusion Criteria:

• Primary Diagnosis of GAD (DSM IV, 300.02) as established by the clinician using all sources of data including the MINI structured interview
• HAM A score ³20 at the Screening (Study Day -7) and Baseline (Study Day 1) Visits by observer rating
• Good health as determined by medical history, physical examination, vital signs, electrocardiography (ECG), and clinical laboratory measurements
• Covi Anxiety Scale total score ³9 and Raskin Depression Scale total score £7 at the Screening Visit (to ensure predominance of anxiety symptoms over depression symptoms)
• Age 18 to 65 (inclusive)

Exclusion Criteria:

• Patients with most other current DSM-IV Axis I disorders.
• Patients with current or past schizophrenia, Psychotic disorder
• Delirium, dementia, amnestic, and other clinically significant cognitive disorders
• Bipolar or schizoaffective disorder
• Benzodiazepine abuse or dependence; and/or Factitious disorder.