The major purpose of the study is to help determine whether giving the combination of Elzasonan with Zoloft to people with depression is a better treatment than taking Zoloft alone. This study will also compare the safety and tolerability of Elzasonan and Zoloft combination to Zoloft alone or placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
262
Pfizer Investigational Site
Beverly Hills, California, United States
Pfizer Investigational Site
Norwich, Connecticut, United States
The estimated treatment difference (elzasonan plus sertraline - sertraline monotherapy) in MADRS (Montgomery-Asberg Depression Rating Scale) remission rates at Week 8 in patients with MDD.
Change from baseline in: MADRS, CGI-I, CGI-S, HAMA, HAMD17, CSFQ, SOS-10 and PGID-D total scores at Week 8. Treatment differences in MADRS response rates at Week 8.
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Pfizer Investigational Site
New York, New York, United States
Pfizer Investigational Site
Beachwood, Ohio, United States
Pfizer Investigational Site
Santiago, RM, Chile
Pfizer Investigational Site
Viljandi, Viljandi Mk., Estonia
Pfizer Investigational Site
Pärnu, Estonia
Pfizer Investigational Site
Tallinn, Estonia
Pfizer Investigational Site
Gatchina, Leningradskaya Oblast', Russia
Pfizer Investigational Site
Moscow, Russia
...and 9 more locations