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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

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
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2007-003159-36-SE
Enrollment
615
Registered
2007-08-30
Start date
2007-10-24
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

Treatment of Major depressive disorder MedDRA version: 9.1 Level: LLT Classification code 10025453 Term: Major depressive disorder NOS

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: 1. Male or female patients. 2. 18 to 65 years of age. 3. Diagnosis of major depressive disorder, recurrent, as defined by Diagnostic and Statistical Manual of Mental Disorders, 4th edition, Text Revision (DSM-IV-TR) criteria (296.3) and confirmed by the semi-structured 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) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Montgomery-Asberg Depression Rating Scale (MADRS) total score of less than 24 (<24) at Visit 1 (Day –7) or Visit 2 (Day –1). - 17-item HAM-D total score of less than 18 (<18) at Visit 1 (Day –7) or Visit 2 (Day –1)

Design outcomes

Primary

MeasureTime frame
Main Objective: - To evaluate the efficacy of saredutant 100 mg once daily in combination with escitalopram 10 mg once daily compared to saredutant placebo in combination with escitalopram 10 mg once daily in patients with major depressive disorder, as assessed by the change from baseline (Day –1) to Day 56 in the 17-item Hamilton Depression Rating Scale (HAM-D) total score. - To evaluate the effect of saredutant 100 mg once daily in combination with escitalopram 10 mg once daily compared to saredutant placebo in combination with escitalopram 10 mg once daily on sexual function in patients with major depressive disorder, as assessed by the change from baseline (Day -1) to Day 56 in the Changes in Sexual Functioning Questionnaire (CSFQ) total score ;Secondary Objective: To evaluate the tolerability and safety of saredutant 100 mg once daily in combination with escitalopram 10 mg once daily in patients with major depressive disorder;Primary end point(s): • The change from baseline (Day –1) to Day 56 in the 17-item HAM-D total score in the intent-to-treat (ITT) population. • The change from baseline (Day –1) to Day 56 in the CSFQ total score in the ITT population.—

Countries

Finland, France, Sweden

Outcome results

None listed

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