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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Dosage from: 50-100 mg oral capsule Dosage and frequency: 50-350 mg once or twice a day Duration: 6 months
Pfizer Investigational Site
Orlando, Florida, United States
Pfizer Investigational Site
Prairie Village, Kansas, United States
Discontinuations due to adverse events or adverse events occurring during and after the discontinuation of trial medication
Time frame: Weekly
The nature, incidence, duration, and severity of adverse events.
Time frame: Weekly
Suicide related adverse events will be further assessed using the Columbia Suicide Severity Rating Scale as needed
Time frame: As needed
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
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
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)
Overall Health Care utilization will be assessed with the Health Care Utilization (HCU) questionnaire.
Time frame: Twice at Wk 13 and Wk 26/EOT
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
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Plasma concentrations will be collected to evaluate the population pharmacokinetics and the dose/exposure relationships for safety and efficacy .
Time frame: 1 time