Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 1:21 PM
Ignite Modification Date:
2025-12-24 @ 1:21 PM
NCT ID:
NCT01034995
Brief Summary:
Primary Objective:
* To evaluate the efficacy of three fixed doses of SSR125543 (20 mg daily, 50 mg daily, and 100 mg daily) compared to placebo in outpatients with major depressive disorder, as assessed by the change from baseline (Day -1) to Day 56 in the 17-item Hamilton Depression Rating Scale (HAM-D) total score.
Secondary Objectives:
* To evaluate the tolerability and safety of SSR125543 in outpatients with major depressive disorder
* To evaluate plasma concentrations of SSR125543
Detailed Description:
This duration of this trial is 11 weeks.
Study:
NCT01034995
Study Brief:
Protocol Section:
NCT01034995