- Healthy males or females with a diagnosis of Generalized Anxiety Disorder (GAD)
(Diagnostic and Statistical Manual-IV [DSM-IV], 300.02).
- HAM-A Total Score ≥20 and item #1 on the HAM-D (depressed mood score) ≤2 at both
Screening and Baseline/Randomization.
- Current diagnoses (within the 6 months) of Major Depressive Disorder; Obsessive
Compulsive Disorder; Panic Disorder; Posttraumatic Stress Disorder; Anorexia; Bulimia;
Caffeine-induced anxiety disorder;
- Any of the following past or current diagnoses: Schizophrenia; Psychotic Disorder;
Delirium, Dementia, Bipolar or Schizoaffective Disorder; Cyclothymic Disorder;
Dissociative Disorders; Antisocial or borderline personality disorder
- Current use of psychotropic medications (i.e., drugs normally prescribed for
depression, mania, anxiety, insomnia, or psychosis) that could not be discontinued 2
weeks prior to dosing.