The study is to assess the performance characteristics of a new measure to assess onset of efficacy in a GAD patient population.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Enrollment
169
1.0 mg p.o. three times a day for three days, then 1.5mg p.o. three times a day for 25 days
placebo p.o. t.i.d. for 28 days; placebo matching lorazepam and paroxetine
20mg p.o. daily for 28 days; and matching placebo twice a day to maintain blind
Pfizer Investigational Site
Glendale, California, United States
Pfizer Investigational Site
Northridge, California, United States
Average change from baseline over the first 6 days of treatment assessment (Study Days 2 through 7) on the Daily Assessment of Symptoms - Anxiety (DAS-A) questionnaire.
Time frame: baseline, days 2 through 7
CGIC at endpoint (LOCF)
Time frame: endpoint
PGIC at endpoint (LOCF)
Time frame: endpoint
Q-LES-Q change from baseline to endpoint (LOCF)
Time frame: baseline, endpoint
SF-36v2 Mental Health change from baseline to endpoint (LOCF)
Time frame: baseline, endpoint
HADS-A change from baseline to endpoint (LOCF)
Time frame: baseline, endpoint
HADS-D change from baseline to endpoint (LOCF)
Time frame: baseline, endpoint
Change from baseline to endpoint (Weeks 1, 2, 4, and 5) in the HAM-A total score.
Time frame: baseline and weeks 1,2,4, and 5
Change from baseline to daily time point (Study Days 2 through 7) on the DAS-A.
Time frame: baseline and days 2 through 7
DAS-A change from baseline to endpoint (LOCF)
Time frame: baseline to endpoint
DAS-A 30% and 50% improvement at endpoint;
Time frame: endpoint
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Pfizer Investigational Site
Orange, California, United States
Pfizer Investigational Site
San Diego, California, United States
Pfizer Investigational Site
Sherman Oaks, California, United States
Pfizer Investigational Site
Van Nuys, California, United States
Pfizer Investigational Site
Casselberry, Florida, United States
Pfizer Investigational Site
Orlando, Florida, United States
Pfizer Investigational Site
Atlanta, Georgia, United States
Pfizer Investigational Site
Marietta, Georgia, United States
...and 5 more locations
DAS-A 30% sustained improvement beginning at week 1
Time frame: baseline, week1, 2,4,
HAM-A 30% sustained improvement beginning at week 1
Time frame: baseline, weeks 1,2,4
HAM-A 30% and 50% improvement at endpoint
Time frame: endpoint
GA-VAS average change from baseline over the first 6 days
Time frame: baseline, days 2-7
Change from baseline to daily time point on the GA-VAS(study days 2 through 7)
Time frame: baseline, days 2-7
GA-VAS change from baseline to endpoint
Time frame: aseline, endpoint
GA-VAS sustained 30% improvement beginning at week 1
Time frame: baseline, weeks 1,2,4
GA-VAS 30% and 50% improvement at endpoint
Time frame: endpoint