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An Eight-Week, Multinational, Multicenter, Randomized, Double-blind, Placebo-controlled Study, with Escitalopram as an Active Control, to Evaluate the Efficacy, Safety and Tolerability of a Saredutant 100 mg Dose Once Daily, in Elderly Patients with Major Depressive Disorder

An Eight-Week, Multinational, Multicenter, Randomized, Double-blind, Placebo-controlled Study, with Escitalopram as an Active Control, to Evaluate the Efficacy, Safety and Tolerability of a Saredutant 100 mg Dose Once Daily, in Elderly Patients with Major Depressive Disorder

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2006-003793-94-CZ
Enrollment
375
Registered
2006-08-25
Start date
2006-10-20
Completion date
Unknown
Last updated
2012-03-19

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

Conditions

to Evaluate the Efficacy, Safety and Tolerability of a Saredutant 100 mg Dose Once Daily, in Elderly Patients with Major Depressive Disorder (MDD)

Interventions

Product Name: saredutant succinate Product Code: SR48968C Pharmaceutical Form: Capsule, hard INN or Proposed INN: saredutant succinate CAS Number: 176381-98-9 Current Sponsor code: SR48968C Concentrat

Sponsors

sanofi-aventis recherche & développement
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: - Male or female - At least 60 years of age - Diagnosis of major depressive disorder as defined by Diagnostic and Statistical Manual of Mental Disorders, 4th edition, Text Revision (DSM-IV-TR) criteria and confirmed by the Mini International Neuropsychiatric Interview (MINI) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Total score of 22 or less on the Montgomery-Asberg Depression Rating Scale (MADRS) - HAM-D total score of 16 or less - MMSE score of 22 or less

Design outcomes

Primary

MeasureTime frame
Main Objective: To evaluate the efficacy of saredutant 100 mg once daily compared to placebo with escitalopram as an active control, in elderly patients with major depressive disorder (MDD), as assessed by a change from baseline to Visit 6 (Day 56) in the 17-item Hamilton Depression Rating Scale (HAM-D) total score.;Secondary Objective: - To evaluate the tolerability and safety of saredutant in elderly patients with major depressive disorder - To evaluate the efficacy of saredutant compared to placebo on disability and quality of life in patients with major depressive disorder - To evaluate plasma concentrations of saredutant and SR49596 (inactive metabolite) - To evaluate the safety and tolerability of twenty-four weeks of additional treatment with saredutant in patients completing the initial eight-week treatment period;Primary end point(s): change from baseline to Visit 6 (Day 56) in the 17-item HAM-D total score in the intent-to-treat (ITT) population—

Countries

Czech Republic, France, Sweden

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026