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NCT00531622 · ClinicalTrials.gov registry record · Phase 3

An Eight-week Study of Saredutant and Escitalopram as Combination Treatment for Major Depressive Disorder

A Phase 3 study, sponsored by Sanofi.

Completed
Registry status
Phase 3
Development phase
643
Enrollment target

NCT00531622: Completed Phase 3 study, sponsored by Sanofi.

NCT00531622 is a Phase 3 study that has completed, run by Sanofi. The registered enrollment target is 643 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (17% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00531622, a Phase 3 study, has completed, sponsored by Sanofi.

COMPLETED
Registry status
Phase 3
Development phase
643 participants
Enrollment target

Study Summary

The main purpose of this study is to evaluate the efficacy of saredutant 100mg once daily in combination with escitalopram 10mg once daily compared to saredutant placebo in combination with escitalopram 10mg once daily in patients with major depressive disorder. This study also includes a double-placebo group (saredutant placebo in combination with escitalopram placebo).

Interventions

  • DRUG placebo
  • DRUG escitalopram
  • DRUG saredutant (SR48968)

Trial Details

FieldValue
Enrollment Target 643 participants
Start Date 2007-09
Est. Completion 2009-01
Phase Phase 3
Sanofi

713 total trials

What the finished NCT00531622 record still lists

NCT00531622 is an interventional study that assigns participants to a tested intervention. The registered 643 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (17% lower).

The record links to 0 conditions, and to 3 interventions - of which placebo is the first listed.

NCT00531622 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00531622 about?

NCT00531622 is a clinical study titled "An Eight-week Study of Saredutant and Escitalopram as Combination Treatment for Major Depressive Disorder". The main purpose of this study is to evaluate the efficacy of saredutant 100mg once daily in combination with escitalopram 10mg once daily compared to saredutant placebo in combination with escitalopram 10mg once daily in patients with major depressive disorder. This study also includes a double-pla...

What is the current status of trial NCT00531622?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 643 participants. The study started on 2007-09. Estimated completion is 2009-01.

What interventions are being tested in trial NCT00531622?

The interventions under investigation include: placebo (DRUG), escitalopram (DRUG), saredutant (SR48968) (DRUG).

Who is sponsoring clinical trial NCT00531622?

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

How this trial's enrollment target compares

Where NCT00531622's enrollment target sits among peer trials

643 573rd of 2000 higher than 1,427 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 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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Source: ClinicalTrials.gov NCT00531622, the US trial registry maintained by the National Library of Medicine. NCT00531622 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.