Efficacy and safety of agomelatine oral administration (25 to 50 mg/day) in elderly patients suffering from Major Depressive Disorder. A 8-week, randomised, double-blind, flexible-dose, parallel groups, placebo-controlled, international, multicentre study followed by an extension double-blind treatment period of 16 weeks

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-011795-29-FI

Enrollment

210

Registered

2009-07-16

Start date

2009-09-04

Completion date

Unknown

Last updated

2012-05-15

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

Conditions

Major Depression MedDRA version: 13.1 Level: PT Classification code 10057840 Term: Major depression System Organ Class: 10037175 - Psychiatric disorders

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

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Out-patients of both genders - Aged older than 65 years (inclusive) - fulfilling DSM-IV criteria for Major Depressive Disorder, recurrent. 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) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: All types of depression other than Major Depressive Disorder Recurrent ; Presence of dementia or MCI ; Severe or uncontrolled organic diseases, likely to interfere with the conduct of the study.

Design outcomes

Primary

Measure	Time frame
Main Objective: Efficacy of agomelatine compared to placebo, in elderly out-patients suffering from Major Depressive Disorder.;Secondary Objective: To provide additional efficacy, safety and pharmacokinetic data. To study the subgroup of patients aged 75 years old and older. ;Primary end point(s): HAM-D-17 total score	—

Countries

Finland, Portugal

Outcome results

None listed

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