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CompletedNCT00319709ZEPHIRUpdated Mar 12, 2009

An Eight-Week Study to Evaluate the Efficacy and Safety of SR58611A in Elderly Patients With Depression

A Phase 3 interventional study of SR58611A in Depressive Disorder, sponsored by Sanofi. Completed at 5 sites in 5 countries. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2009-03-12.

Sponsored by Sanofi · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
288
Allocation
Randomized
Ages
65 Years and older
Sex
All
01

Study summary

The purpose of the study is to evaluate the efficacy and safety of SR58611A in elderly patients with depression.The primary objective is to evaluate the efficacy of a 700 mg dose of SR58611A compared to placebo in elderly patients with depression. The secondary objectives are to evaluate the safety of SR58611A and to evaluate the efficacy of SR58611A on disability and quality of life in elderly patients with depression.

02

Conditions studied

  • Depressive Disorder

Keywords

  • depression
  • antidepressive agents
  • controlled clinical trial
03

In context

Depressive Disorder

4,845 studies on the registry are indexed under Depressive Disorder; 514 are open to participants now.

This study's enrollment of 288 is above the median of 80 across 3,999 interventional studies indexed under Depressive Disorder.

Browse Depressive Disorder studies →

Lead sponsor

Sanofi is the lead sponsor of 1,508 studies on the registry; 90 are open to participants now.

Of its 198 completed or terminated interventional studies of FDA-regulated products, 118 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Outpatients or inpatients
  • Major Depressive Disorder (MDD) with a recurrent Major Depressive Episode (MDE) according to DSM IV-TR criteria.
  • MADRS score equal of above 22.

Exclusion criteria

Exclusion Criteria:

  • Patients with a current significant risk of suicide in the investigator's clinical judgment.
  • The duration of the current depressive episode is greater than 2 years.
  • Patients whose current depressive episode is secondary to a general medical condition
  • Patients with a lifetime history according to MINI at screening of:bipolar disorder, psychotic disorder, antisocial personality disorder.
  • Patients with a current history according to MINI at screening of anxiety disorders, alcohol dependence or abuse or substance dependence or abuse
  • Patients with severe or unstable concomitant medical conditions.
  • History of seizures other than a single childhood febrile seizure.
  • Patients with abnormal thyroid functioning.
  • Patients with clinically significant ECG findings at screening.
  • Patients who have taken an investigational drug in the last 3 months prior to screening.
  • Any subject who has previously participated in a SR58611A protocol.
  • Patients with Mini-Mental State Examination (MMSE) score \< 25 at screening.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
288 participants (actual)

Interventions

  • DrugSR58611A
06

What researchers measure

Primary outcomes

  1. The primary outcome of the study is the change from baseline to Day 56 of treatment in the Hamilton Depression Rating Scale (HAM-D) total score.

Secondary outcomes

  1. The main secondary outcomes are the changes from baseline to Day 56 of treatment in the HAM-D depressed mood item, the Montgomery Asberg Depression Rating Scale total, and the Clinical Global Impression Severity of Illness scores.

07

Study locations

5 sites
  • Sanofi-Aventis Administrative Office
    Sofia, Bulgaria
  • Sanofi-Aventis Administrative Office
    Helsinki, Finland
  • Sanofi-Aventis Administrative Office
    Bucuresti, Romania
  • Sanofi-Aventis Administrative Office
    Belgrade, Serbia
  • Sanofi-Aventis Administrative Office
    Bratislava, Slovakia
08

References and documents

Related links

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 12, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00319709
Lead sponsor
Sanofi
First posted
Apr 27, 2006
Start date
Apr 2006
Primary completion
Apr 2007
Completion
Aug 2007
Last update
Mar 12, 2009

Study contacts

ICD CSD
study director · Sanofi
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2009. You cannot join it, but the record below documents what was studied.

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