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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 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.

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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

Sponsor

Sanofi

713 total trials

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What the Registry Record Tells You About NCT00252356

The ClinicalTrials.gov registry entry for NCT00252356 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 468 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 375-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (25% higher). The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.

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 2 study locations spanning 2 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.