Evaluation of efficacy and clinical benefit of agomelatine in patients with major depressive disorder compared to serotonin-norepinephrine reuptake inhibitor (SNRI)

Evaluation of efficacy and clinical benefit of agomelatine (25 to 50 mg/day) over a 6-month treatment period in patients with Major Depressive Disorder.A randomised, double-blind, international multicentre study with parallel groups versus duloxetine (60 mg/day).Twenty-four weeks of treatment.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN96725312

Enrollment

400

Registered

2009-05-08

Start date

2009-04-29

Completion date

Unknown

Last updated

2020-05-04

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 SNRI over a 6-month period.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Aged between 18 and 65 years, either sex 2. Out-patients fulfilling Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) criteria for major depressive disorder

Exclusion criteria

Exclusion criteria: Women of childbearing potential without effective contraception

Design outcomes

Primary

Measure	Time frame
Hamilton Rating Scale for Depression (HAM-D) total score, from baseline to week 24.	—

Secondary

Measure	Time frame
1. HAM-D items, from baseline to week 24 2. Clinical Global Impression scale, from baseline to week 24 3. Pittsburgh Sleep Quality Index, from baseline to week 24 4. Leeds Sleep Evaluation Questionnaire, from week 1 to week W2 5. Sheehan Disability Scale, from baseline to week 24 6. Safety from baseline to week 24	—

Countries

Australia, Brazil, Canada, Greece, Hungary, Italy, Portugal, South Africa, Spain, United Kingdom

Outcome results

None listed

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