This study will evaluate the efficacy and safety of PD 0332334 for the treatment of generalized anxiety disorder.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
551
Capsules, oral, 300 mg BID, 8 weeks with 2 week taper.
Capsules, oral, placebo BID, 8 weeks with 2 week taper.
Capsules, oral, 225 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
Response rate on the clinician-rated CGI-I at Week 1 and Week 8.
Time frame: 8 weeks
Change from Baseline to Week 8 on the Medical Outcomes Study-Sleep Scale (MOSS-SS) subscales.
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, 8 on the DAS-A (total score).
Time frame: 8 weeks
Response rate on the HAM-A at Week 1 and Week 8.
Time frame: 8 weeks
Change from Baseline in the somatic subscale score of the HAM-A (Items 7-13) at Week 8.
Time frame: 8 weeks
Remission rate based on the HAM-A at Week 1 and Week 8.
Time frame: 8 weeks
Response rate on the patient-rated PGI-C at Week 8.
Time frame: 8 weeks
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Capsules, oral, 175 mg BID, 8 weeks with 2 week taper.
Pfizer Investigational Site
Beverly Hills, California, United States
Pfizer Investigational Site
Encino, California, United States
Pfizer Investigational Site
National City, California, United States
Pfizer Investigational Site
Newport Beach, California, United States
Pfizer Investigational Site
San Diego, California, United States
Pfizer Investigational Site
Sherman Oaks, California, United States
Pfizer Investigational Site
Farmington, Connecticut, United States
Pfizer Investigational Site
Jacksonville, Florida, United States
Pfizer Investigational Site
Jacksonville, Florida, United States
Pfizer Investigational Site
Orlando, Florida, United States
...and 33 more locations
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 in 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 Sheehan Disability Scale subscales.
Time frame: 8 weeks
Change from Baseline in CGI-S at 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 8 on the Medical Outcomes Study Sleep Scale (MOS-SS) 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) total score.
Time frame: 1 week
Change from Baseline to Days 2-8 and Weeks 2, 4, 6, 8 on the GA-VAS (diary).
Time frame: 8 weeks