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Efficacy and safety of 3 dose regimens of agomelatine (10, 25, 25-50 mg) versus placebo given once a day for 6 weeks in out-patients suffering from moderate to severe Major Depressive Disorder. A 6-week randomised, double-blind, placebo-controlled, parallel groups study followed by a double-blind optional 18-week extension period.

Efficacy and safety of 3 dose regimens of agomelatine (10, 25, 25-50 mg) versus placebo given once a day for 6 weeks in out-patients suffering from moderate to severe Major Depressive Disorder. A 6-week randomised, double-blind, placebo-controlled, parallel groups study followed by a double-blind optional 18-week extension period.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2009-011238-84-SK
Enrollment
520
Registered
2009-09-10
Start date
2009-09-21
Completion date
Unknown
Last updated
2012-08-07

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

Conditions

Major Depressive Disorder MedDRA version: 11.1 Level: LLT Classification code 10057840 Term:

Interventions

Trade Name: VALDOXAN Product Name: S20098 Product Code: S20098 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: agomelatine CAS Number: 138112-76-2 Current Sponsor code: S20098 Concentrati

Sponsors

Institut de Recherches Internationales Servier
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Out-patients of both genders - Aged between 18 (or minimum legal age) and 65 years (inclusive) - fulfilling DSM-IV criteria for Major Depressive Disorder 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: - Women of childbearing potential without effective contraception, - Other types of depression than MDD, - Severe or uncontrolled organic diseases, likely to interfere with the conduct of the study

Design outcomes

Primary

MeasureTime frame
Main Objective: Short-term efficacy (HAM-D) of 3 dose regimens of agomelatine versus placebo.;Secondary Objective: Short-term and long term efficacy and safety of 3 dose regimens of agomelatine.;Primary end point(s): HAM-D—

Countries

Bulgaria, Finland, Slovakia

Outcome results

None listed

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