This study will assess the long-term safety and tolerability of 350 to 600 mg/day of PD 0332334 administered in split dose (twice daily) in subjects with Generalized Anxiety Disorder.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
468
Dosage Form: 25 or 100 mg oral capsules Dosage and frequency: 350-600 mg twice a day Duration: 1 year
The nature, incidence, and duration of adverse events monitored throughout the study by physical exam
Time frame: Screening, Wk 25 & Wk 52/EOT
Electrocardiogram will be performed at screening and during follow up visits to assess the safety and tolerability of the compound in terms of clinically significant cardiovascular changes
Time frame: Screening, Wk 4, Wk 25, Wk 52/EOT
The Columbia Suicide Severity Rating scale will be used to assess any suicide related adverse events
Time frame: As needed
The nature, incidence, and duration of adverse events monitored throughout the study by vital signs evaluation at each visit, weight measurements and clinical laboratory monitoring periodically
Time frame: Screening, Baseline, Wk 4, Wk 12, Wk 25, Wk 38, & Wk 52/EOT
All discontinuations due to adverse events will be reviewed throughout the trial to assess the safety and tolerability of the compound
Time frame: Weekly
The Hamilton Rating Scale for Anxiety (HAM-A) will be used to assess symptoms of Generalized Anxiety Disorder (GAD) over a one year time period.
Time frame: Baseline, Wk 12, Wk 25, Wk 38, Wk 51 & Wk 52/EOT
The Clinical Global Impression of Severity (CGI-S), and the Daily Diary (DD) will also be used to assess symptoms of GAD over a one year time period.
Time frame: Baseline, Wk 51 & Wk 52/EOT
The Health Care Utilization Questionnaire will be utilized to assess overall Health Care over a one year time period.
Time frame: Baseline, Wk 12, Wk 25, Wk 38 & Wk 51
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