A 10-Week Study Evaluating the Efficacy And Safety of PD 0332334 for the Treatment of Generalized Anxiety Disorder

• Drug: PD 0332334
  
  Capsules, oral, 300 mg BID, 8 weeks with 2 week taper.
  Other Name: imagabalin
• Drug: Placebo
  
  Capsules, oral, placebo BID, 8 weeks with 2 week taper.
• Drug: PD 0332334
  
  Capsules, oral, 225 mg BID, 8 weeks with 2 week taper.
• Drug: PD 0332334
  
  Capsules, oral, 175 mg BID, 8 weeks with 2 week taper.

• Experimental: PD 0332334 300 mg BID
  
  Intervention: Drug: PD 0332334
• Placebo Comparator: Placebo BID
  
  Intervention: Drug: Placebo
• Experimental: PD 0332334 225 mg BID
  
  Intervention: Drug: PD 0332334
• Experimental: PD 0332334 175 mg BID
  
  Intervention: Drug: PD 0332334

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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 allergies).
• 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 disorders.
• Antisocial or borderline personality disorder.
• Serious suicidal risk per the clinical investigator's judgment.