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NCT00252356 · ClinicalTrials.gov registry record · Phase 3

Efficacy and Safety of SR58611A in Patients With Major Depressive Disorder

A Phase 3 study of Major Depressive Disorder, sponsored by Sanofi.

Completed
Registry status
Phase 3
Development phase
468
Enrollment target
2
Study locations

NCT00252356: Completed Phase 3 study of Major Depressive Disorder, sponsored by Sanofi.

NCT00252356 is a Phase 3 study of Major Depressive Disorder that has completed, run by Sanofi. The registered enrollment target is 468 participants, above the 375-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (25% higher). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00252356, a Phase 3 study of Major Depressive Disorder, has completed, sponsored by Sanofi.

COMPLETED
Registry status
Phase 3
Development phase
468 participants
Enrollment target
2
Study locations

Study Summary

To evaluate the efficacy of a fixed dose of SR58611A(350 mg q12) compared to placebo in patients with MajorDepressive Disorder (MDD) using escitalopram (10 mgqd) as positive control. The study is a multicenter, US and Canadian, randomized, double-blind, 3-parallel-group, placebo- and escitalopram-controlled, Phase III study consisting of four segments (A, B, C and D). Segment A is a 1-week, placebo, single-blind period. Segment B is an 8-week, double-blind period. Segment C is an optional 18-week double-blind extension period. Segment D is a 1-week safety follow-up period after study drug discontinuation or early termination (during Segment B or C).

Conditions Studied

Major Depressive Disorder

Interventions

  • DRUG SR58611A

Study Locations (2)

New Jersey

  • Sanofi-Aventis Administrative Office - Bridgewater

Other

  • Sanofi-Aventis Administrative Office - Laval

Trial Details

FieldValue
Enrollment Target 468 participants
Start Date 2005-09
Est. Completion 2007-05
Phase Phase 3
Sanofi

713 total trials

What the finished NCT00252356 record still lists

NCT00252356 is an interventional study that assigns participants to a tested intervention. The registered 468 participants enrollment target is mid-sized for trials with a published cap, above the 375-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (25% higher).

The record links to 1 condition, with Major Depressive Disorder appearing as the primary indexed condition, and to 1 intervention - of which SR58611A is the first listed.

NCT00252356 reports a single indexed study location in New Jersey, Other.

Frequently Asked Questions

What is clinical trial NCT00252356 about?

NCT00252356 is a clinical study titled "Efficacy and Safety of SR58611A in Patients With Major Depressive Disorder". To evaluate the efficacy of a fixed dose of SR58611A(350 mg q12) compared to placebo in patients with MajorDepressive Disorder (MDD) using escitalopram (10 mgqd) as positive control. The study is a multicenter, US and Canadian, randomized, double-blind, 3-parallel-group, placebo- and escitalopram-co...

What is the current status of trial NCT00252356?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 468 participants. The study started on 2005-09. Estimated completion is 2007-05.

What conditions does trial NCT00252356 study?

This clinical trial studies the following conditions: Major Depressive Disorder.

What interventions are being tested in trial NCT00252356?

The interventions under investigation include: SR58611A (DRUG).

Who is sponsoring clinical trial NCT00252356?

This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00252356 being conducted?

This trial has 2 study locations across New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Major Depressive Disorder

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT00252356's enrollment target sits among peer trials

468 39th of 282 higher than 244 of 282 other Major Depressive Disorder trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Major Depressive Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT00252356, the US trial registry maintained by the National Library of Medicine. NCT00252356 (mid enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.