- 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 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.