- 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 diagnosis: 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.