This is a 10-week trial that evaluates the efficacy and safety of PD 0332334 in subjects ages 18 and older 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
TRIPLE
Enrollment
286
Capsules, oral, 225 mg BID, 8 weeks, with 2 week taper
Capsules, oral, 300 mg BID, 8 weeks, with 2 week taper
Capsules, oral, 20 mg q am, 8 weeks, with 2 week taper
Change from Baseline in HAM-A total score at Week 8
Time frame: 8 weeks
To assess the safety and tolerability of PD 0332334 in subjects with GAD
Time frame: 8 weeks with taper
Response rate on the HAM-A at Week 1 and Week 8
Time frame: 8 weeks
Remission rate based on the HAM-A at Week 8
Time frame: 8 weeks
Change from Baseline in the somatic subscale score of the HAM-A (item 7-13) at Week 8
Time frame: 8 weeks
Change from Baseline to Week 8 on the Medical Outcomes Study - Sleep Scale subscales
Time frame: 8 weeks
Worsening and improvement (from Baseline to Week 8) on the Changes in Sexual Functioning Questionnaire (CSFQ).
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 in the HAM-A total score at Weeks 1, 2, 4 and 6)
Time frame: 6 weeks
Response rate on the PGI-C at Week 8
Time frame: 8 weeks
Response rate on the CGI-I at Week 1 and Week 8
Time frame: 8 weeks
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Capsules, oral, BID, 8 weeks, with 2 week taper
Pfizer Investigational Site
Birmingham, Alabama, United States
Pfizer Investigational Site
Glendale, California, United States
Pfizer Investigational Site
Orange, California, United States
Pfizer Investigational Site
Temecula, California, United States
Pfizer Investigational Site
Upland, California, United States
Pfizer Investigational Site
Wildomar, California, United States
Pfizer Investigational Site
Fort Myers, Florida, United States
Pfizer Investigational Site
Orange City, Florida, United States
Pfizer Investigational Site
Atlanta, Georgia, United States
Pfizer Investigational Site
Marietta, Georgia, United States
...and 18 more locations
Change from Baseline to Week 8 on the Medical Outcomes Study Sleep Scale (MOS-SS) Sleep Disturbance Score
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
Change from Baseline to Days 2-8 and Weeks 2, 4, 6 and 8 on the GA-VAS (diary)
Time frame: 8 weeks
The "Week 1 Sustained Responser" rate based on the HAM-A
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 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 in the Q-Les-Q General Activities Score
Time frame: 8 weeks
Change from Baseline to Week 1 on the Medical Outcomes Study Sleep Scale (MOS-SS) Sleep Disturbance Score
Time frame: 1 week
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 in CGI-S at Week 8
Time frame: 8 weeks