Efficacy and safety of agomelatine oral administration (25 to 50 mg/day) in elderly patients suffering from major depressive disorder: an 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

"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

Phase 3

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN57507360

Enrollment

210

Registered

2010-04-30

Start date

2009-11-04

Completion date

Unknown

Last updated

2018-05-21

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

Conditions

Major depressive disorder Mental and Behavioural Disorders Depressive episode

Interventions

Agomelatine 25 or 50 mg versus placebo. 8-week treatment followed by an extension double-blind treatment period of 16 weeks.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Out-patients of both genders aged more than 65 years 2. Fulfilling Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) criteria for a moderate to severe episode of a recurrent major depressive disorder

Exclusion criteria

Exclusion criteria: 1. All types of depression other than major depressive disorder recurrent 2. Severe or uncontrolled organic diseases, likely to interfere with the conduct of the study 3. Current diagnosis of neurological disorders

Design outcomes

Primary

Measure	Time frame
HAM-D total score, on the week 0 - 8 period	—

Secondary

Measure	Time frame
1. Clinical Global Impression scale scores, from baseline to week 8 and 24 2. Sheehan Disability Scale scores, from baseline to week 8 and 24 3. Safety from baseline to week 8 and 24	—

Countries

Argentina, Finland, Mexico, Portugal, Romania

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 10, 2026