6-Month Open-Label Safety Study Of PD 0332334 In Elderly Patients With Generalized Anxiety Disorder (GAD)

A Phase 3, 6-Month Open-Label Safety Study Of PD 0332334 In Elderly Patients With Generalized Anxiety Disorder

This is an open-label, multi-site, 6-month study of an investigational compound in elderly outpatients, age 65 years old or above, to assess the long-term safety and tolerability of the compound in the treatment of elderly subjects with Generalized Anxiety Disorder (GAD).

Termination reason: On February 23rd 2009, a decision to terminate further development for PD 0332334 was communicated to investigators in this study. The decision to terminate this study was not based on any safety concerns.

Inclusion Criteria:

• Men or women age > 65 years.
• A primary diagnosis of Generalized Anxiety Disorder according to the Diagnostic and Statistical Manual-IV (DSM-IV).
• Subjects must have a HAM-A score of 16 or higher at both screening and baseline visits.

Exclusion Criteria:

• Women who are pregnant or contemplating pregnancy (eg, via in vitro fertilization) during the study through 30 days after the last dose of study medication.
• Subjects with evidence of a current (within the past 6 months) clinically significant or unstable hematological, autoimmune, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, pancreatic, psychiatric, neurologic, immunological or retinal disorder; subjects with an active infection within the past 2 months.
• Subjects who have an ongoing, unresolved, clinically significant cardiovascular or cerebrovascular medical problem.
• Mini Mental Status Exam (MMSE) score <24 or possibility of undiagnosed dementia, cognitive or amnestic disorder, including, but not limited to mild cognitive impairment.