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An eight-week, multinational, multicenter, double-blind, active- and placebo-controlled clinical trial evaluating the efficacy and tolerability of three fixed doses of SSR125543 (20 mg daily, 50 mg daily and 100 mg daily) in outpatients with major depressive disorder. - AGATE

An eight-week, multinational, multicenter, double-blind, active- and placebo-controlled clinical trial evaluating the efficacy and tolerability of three fixed doses of SSR125543 (20 mg daily, 50 mg daily and 100 mg daily) in outpatients with major depressive disorder. - AGATE

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2009-010339-42-BE
Enrollment
580
Registered
2009-10-27
Start date
2010-02-10
Completion date
Unknown
Last updated
2022-01-04

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

Conditions

Major depression disorders and irritable bowel syndrome. MedDRA version: 12.0 Level: LLT Classification code 10025453 Term: Major depressive disorder NOS MedDRA version: 12.0 Level: LLT Classification code 10023003 Term: Irritable bowel syndrome

Interventions

Product Code: SSR125543 Pharmaceutical Form: Capsule, hard Current Sponsor code: SSR125543 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 20- Pharmaceutical form o

Sponsors

Sanofi-Aventis Recherche & Développement
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Diagnosis of major depressive disorder, as defined by the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) criteria and confirmed by the Mini International Neuropsychiatric Interview (MINI) criteria. 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: 1. Age less than 18 years (64) 2. Total score of less than 18 (<18) on the 17-item Hamilton Depression Rating Scale (HAM-D) total score. 3. Total score of less than 24 (<24) on the Montgomery-Asberg Depression Rating Scale (MADRS) total score.

Design outcomes

Primary

MeasureTime frame
Main Objective: To evaluate the efficacy of three fixed doses of SSR125543 (20 mg daily, 50 mg daily and 100 mg daily) compared to placebo in outpatients 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.;Secondary Objective: To evaluate the tolerability and safety of SSR125543 in outpatients with major depressive disorder. To evaluate plasma concentrations of SSR125543. ;Primary end point(s): The primary efficacy endpoint is the change from baseline (Day -1) to Day 56 in the 17-item HAM-D total score.—

Countries

Belgium, Estonia, Finland, France, Germany, Netherlands, Slovakia, Sweden

Outcome results

None listed

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