• Discontinuations due to adverse events or adverse events occurring during and after the discontinuation of trial medication [ Time Frame: Weekly ] [ Designated as safety issue: Yes ]
• The nature, incidence, duration, and severity of adverse events. [ Time Frame: Weekly ] [ Designated as safety issue: Yes ]
• Suicide related adverse events will be further assessed using the Columbia Suicide Severity Rating Scale as needed [ Time Frame: As needed ] [ Designated as safety issue: Yes ]
• The primary outcome is safety which will be assessed throughout the 6-months by physical exams, monitoring of vital signs, body weight changes, and clinical safety laboratory [ Time Frame: Screening, Baseline, Wk 4, Wk 14, Wk 26/EOT, & at FU; Vital signs at every vist ] [ Designated as safety issue: Yes ]
• Electrocardiograms will be performed to assess any changes in cardiac functioning related to the compound [ Time Frame: Screening, Baseline, Wk 4, Wk 15 & Wk 26/EOT ] [ Designated as safety issue: Yes ]

• Symptom severity of generalized Anxiety Disorder (GAD) will be measured by the Hamilton Rating Scale for Anxiety (HAM-A). [ Time Frame: Screening, Baseline, Wk 1-2, Wk 4, Wk 14, Wk 26/EOT & Wk 27 (FU) ] [ Designated as safety issue: No ]
• Overall Health Care utilization will be assessed with the Health Care Utilization (HCU) questionnaire. [ Time Frame: Twice at Wk 13 and Wk 26/EOT ] [ Designated as safety issue: No ]
• Also, the Daily Diary (including the Daily assessment of Symptoms DAS-A and Global Anxiety - Visual Analog Scale (GA-VAS) and the Clinical Global Impression of Severity (CGI-S) will be used to assess symptoms of GAD. [ Time Frame: Screening, Baseline, Wk 1-2, Wk 4, Wk 14, Wk 26/EOT ] [ Designated as safety issue: No ]
• Plasma concentrations will be collected to evaluate the population pharmacokinetics and the dose/exposure relationships for safety and efficacy . [ Time Frame: 1 time ] [ Designated as safety issue: No ]

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.