This is a 10-week trial that evaluates the efficacy and safety of PD 0332334 in subjects, ages from 18 to 65, 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
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
501
Capsules, oral, 175 mg BID, 8 weeks with 2 week taper
Capsules, oral, 225 mg BID, 8 weeks with 2 week taper
Capsules, oral, 75 mg BID, 8 weeks with 2 week taper
The efficacy of PD 0332334 in the treatment of GAD will be measured by the change in the Hamilton Anxiety Rating Scale (HAM-A) total scores from baseline observed following 8 weeks of double-blind treatment.
Time frame: 8 weeks
The safety and tolerability of PD 0332334 in subjects with GAD will be monitored in this study
Time frame: 8 weeks
Worsening and improvement from baseline to week 8 on the changes in the Sexual Functioning Questionnaire (CSFQ)
Time frame: 8 weeks
Response rate on the patient-rated PGI-C at week 8
Time frame: 8 weeks
Change from baseline to week 8 on the Sheehan Disability Scale subscales
Time frame: 8 weeks
Change from baseline in the somatic subscale score of the HAM-A (items 7 - 13)
Time frame: 8 weeks
Response rate on the HAM-A at week 1 and week 8
Time frame: 8 weeks
Response rate on the clinician-rated CGI-I ate week 1 and week 8
Time frame: 8 weeks
Change from Baseline in the psychic subscale score of the HAM A (Items 1- 6 and 14) at Week 8
Time frame: 8 weeks
Change from Baseline to Week 1 on the Medical Outcomes Study Sleep Scale (MOS SS) Sleep Problems Index II
Time frame: 1 week
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Capsules, oral, Paroxetine 20 mg QD, 8 weeks with 2 week taper
Capsules, oral, placebo bid, 8 weeks with 2 week taper
Pfizer Investigational Site
Litchfield Park, Arizona, United States
Pfizer Investigational Site
Costa Mesa, California, United States
Pfizer Investigational Site
Pasadena, California, United States
Pfizer Investigational Site
Redlands, California, United States
Pfizer Investigational Site
Denver, Colorado, United States
Pfizer Investigational Site
Norwich, Connecticut, United States
Pfizer Investigational Site
Altamonte Springs, Florida, United States
Pfizer Investigational Site
Maitland, Florida, United States
Pfizer Investigational Site
Miami, Florida, United States
Pfizer Investigational Site
Miami, Florida, United States
...and 42 more locations
Change from Baseline to Week 8 on the Medical Outcomes Study Sleep Scale (MOS SS) Sleep Problems Index II
Time frame: 8 weeks
Change from baseline in the HAM-A total score at weeks 1, 2, 4, and 6
Time frame: 6 weeks
Change from baseline in the 17-item HAM-D total score at weeks 1, 2, 4, and 8
Time frame: 8 weeks
Change from Baseline to Week 8 on the Medical Outcomes Study Sleep Scale subscales
Time frame: 8 weeks
Remission rate based on the HAM A at Week 8
Time frame: 8 weeks
Change from baseline in CGI-S at week 8
Time frame: 8 weeks
Change from baseline to week 8 in the QLesQ General Activity Score
Time frame: 8 weeks
The "Week 1 Sustained Responder" rate based on the HAM A (where "Week 1 Sustained Responders" are defined as subjects with a 50% or greater improvement from baseline on the HAM A total score at Week 1 that is sustained until the Week 8 visit)
Time frame: 1 week
Change from Baseline to Days 2 8 and Weeks 2, 4, 6, 8 on the DAS A (total score)
Time frame: 8 weeks
Change from baseline to week 8 on the Sheehan Disability Scale (SDS) total score
Time frame: 8 weeks
Change from baseline to Days 2-8 and weeks 2, 4, 6 and 8 on the GA-VAS (diary)
Time frame: 8 weeks
Average (across the week 1, 2, 4, 6 and 8 visits) HAM-A change from baseline score
Time frame: 8 weeks