FindTrial
Sign In

Effects of agomelatine (25 to 50 mg/day) on sleep EEG parameters compared to escitalopram in patients with Major Depressive Disorder. A 6-week randomised, double-blind parallel groups study versus comparator, followed by a double-blind optional treatment extension period up to 6 months.

Effects of agomelatine (25 to 50 mg/day) on sleep EEG parameters compared to escitalopram in patients with Major Depressive Disorder. A 6-week randomised, double-blind parallel groups study versus comparator, followed by a double-blind optional treatment extension period up to 6 months.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2006-004716-48-FI
Enrollment
130
Registered
2006-12-21
Start date
2007-02-14
Completion date
Unknown
Last updated
2012-03-19

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: 8.1 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

Sponsors

Institut de Recherches Internationales Servier
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: - Outpatients of both genders, - Aged between 18 and 60 years, - Fulfilling DSM-IV-TR 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, - Positive plasma beta hCG for women - All types of depression other than Major Depressive Disorder, - Contraindication to escitalopram.

Design outcomes

Primary

MeasureTime frame
Main Objective: To demonstrate that depressed patients treated with agomelatine present a greater improvement in sleep efficiency than patients treated with escitalopram.;Secondary Objective: To show that agomelatine improves other objective sleep parameters, improves subjective sleep, restores a more physiological sleep architecture and does not impair daytime performance in depressed patients.;Primary end point(s): Sleep efficiency index—

Countries

Austria, Finland, France, Spain, United Kingdom

Outcome results

None listed

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