Efficacy of agomelatine (25 to 50 mg/day) given orally on improvement of subjective sleep in patients with Major Depressive Disorder. A randomised, double-blind, flexible-dose international multicentre study with parallel groups versus escitalopram (10 to 20mg/day). Twelve-week treatment plus double-blind extension for 12 weeks.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-006540-54-FR

Enrollment

300

Registered

2007-04-23

Start date

2007-06-11

Completion date

Unknown

Last updated

2021-10-08

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: 9.1 Level: LLT Classification code 10057840 Term: Major depression

Interventions

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 Concentration unit: mg milligram

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Outpatients between 18 (or minimum legal age) and 70 years of age (included), male or female, 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) 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 Severe or uncontrolled organic disease, likely to interfere with the conduct of the study Women of childbearing potential without effective contraception (oral contraceptive pill, intra-uterine contraceptive device, contraceptive implant or condom) as well as pregnant or breastfeeding women

Design outcomes

Primary

Measure	Time frame
Main Objective: To show that patients treated with agomelatine have an earlier improvement of subjective sleep than patients treated with escitalopram;Secondary Objective: To study the effects of agomelatine and escitalopram on depression, other sleep patterns, daytime sleepiness, quality of life and to provide additional safety and acceptability data ;Primary end point(s): Global satisfaction on sleep score expressed in terms of change from baseline	—

Measure

Time frame

Main Objective: To show that patients treated with agomelatine have an earlier improvement of subjective sleep than patients treated with escitalopram;Secondary Objective: To study the effects of agomelatine and escitalopram on depression, other sleep patterns, daytime sleepiness, quality of life and to provide additional safety and acceptability data ;Primary end point(s): Global satisfaction on sleep score expressed in terms of change from baseline

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Countries

France, United Kingdom

Outcome results

None listed

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