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An Eight-Week, Double-Blind, Group-Sequential Design, Placebo Controlled Trial To Evaluate The Safety And Efficacy Of The Co- Administration Of Sertraline And Elzasonan (CP-448,187) In Outpatients With Major Depressive Disorder
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.
Details
| Lead sponsor | Pfizer |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 262 |
| Start date | 2005-12 |
| Completion | 2007-07 |
Conditions
- Depressive Disorder, Major
Interventions
- Sertraline and Elzasonan Combination
- Sertraline
- Placebo
Primary outcomes
- 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.
Countries
United States, Chile, Estonia, Russia