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

An Eight-week, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Saredutant 100 mg Once Daily in Combination With Escitalopram 10 mg Once Daily in Patients With Major Depressive Disorder

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00531622
Enrollment
643
Registered
2007-09-19
Start date
2007-09-30
Completion date
2009-01-31
Last updated
2016-05-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Major Depressive Disorder

Keywords

Depression, Major Depressive Episode, Antidepressant

Brief 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

DRUGsaredutant (SR48968)

oral administration, capsules

DRUGescitalopram

oral administration, capsules

DRUGplacebo

oral administration, capsules

Sponsors

Sanofi
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* Outpatients with recurrent Major Depressive Disorder

Exclusion criteria

* Symptoms of current depressive episode for less than 30 days or more than 2 years * Mild depression, as measured by standard clinical research scales * Significant suicide risk * Lack of sexual activity (including masturbation) * Other psychiatric conditions that would obscure the results of the study * History of failure to respond to antidepressant treatment * Pregnancy or breast-feeding The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Design outcomes

Primary

MeasureTime frame
Change from baseline to Day 56 in Hamilton depression rating scale (HAM-D) total scoreBaseline, Day 56
Change from Baseline to Day 56 in the CGI-S Severity of Illness scoreBaseline, Day 56

Secondary

MeasureTime frameDescription
Change from baseline to Day 56 in the Clinical Global Impression (CGI) severity of illness scoreBaseline, Day 56—
Change from baseline to Day 56 in HAM-D depressed mood item scores.Baseline, Day 56—
Percentage of patients demonstrating a treatment responseDay 56response is defined as a reduction of at least 50% in HAM-D total score between baseline and any post-baseline assessment

Countries

Argentina, Finland, France, Mexico, Sweden, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026