- Diagnosis of GAD (Diagnostic and Statistical Manual-IV [DSM-IV], 300.02) as
established by the clinician (psychiatrist or licensed clinical psychologist) who has
interviewed the subject using all sources of data including the Mini International
Neuropsychiatric Interview (MINI) for DSM-IV Axis I disorders and other clinical
information. Subjects with specific phobia(s) (as defined in DSM-IV) or dysthymic
disorder will be allowed in the study.
- Subjects must have a HAM-A total score >/= 20 at the screening (V1) and randomization
(V2) visits. Subjects must also have a Covi Anxiety Scale score of >/= 9 and a Raskin
Depression Scale score = 7 at the Screening (V1) visit to ensure predominance of
anxiety symptoms over depression symptoms.
- Subjects with evidence or history of clinically significant hematological, renal,
endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, pancreatic,
neurologic, active infections, immunological, or allergic disease (including drug
- Any of the following current (within the past 6 months through the present) DSM-IV
Axis I diagnoses: Major depressive disorder; Obsessive compulsive disorder; Panic
disorder; Agoraphobia; Posttraumatic stress disorder; Anorexia; Bulimia;
Caffeine-induced anxiety disorder; Alcohol or substance abuse or dependence unless in
full remission for at least 6 months; Social anxiety disorder.
- Any of the following past or current DSM-IV Axis I diagnoses: Schizophrenia; Psychotic
disorder; Delirium, dementia, amnestic and other clinically significant cognitive
disorders; Bipolar or schizoaffective disorder; Cyclothymic disorder; Dissociative
- Antisocial or borderline personality disorder.
- Serious suicidal risk per the clinical investigator's judgment.