The purpose of this study is to evaluate the safety and efficacy of PD 0332334 compared to placebo in the treatment of Generalized Anxiety Disorder in an adult population
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
222
250 mg capsule, BID for 4 weeks
100 mg capsule, BID for 4 weeks
0 mg capsule, BID for 4 weeks
HAM-A Total Score
Time frame: 4 weeks
HAM-A total score at week 1, 2 and 4
Time frame: 1. 2. ands 4 weeks
HAM-A somatic and psychic subscales
Time frame: 1, 2, and 4 weeks
HAM-A responders
Time frame: 4 weeks
HAM-A sustained responders
Time frame: Week 1 through week 4
DAS-A (daily assessment of symptoms of anxiety) and GA-VAS (VAS scale for global anxiety)
Time frame: Day 2 through day 7
CGI-I (Clinical Global Impression of Improvement) and PGI-I (Patient Global Impression of Change)
Time frame: 1 and 4 weeks
HAM-D total score
Time frame: 1 and 4 weeks
Sheehan Disability Score (SDS)
Time frame: 4 weeks
Treatment Satisfaction Questionaire for Medication
Time frame: 4 weeks
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1 mg capsule, BID for 4 weeks