Effect of agomelatine (25 mg) given orally once a day for 7 days on cerebral activity measured by functional MRI during processing of emotional stimuli in patients with Major Depressive Disorder. A randomised, double-blind, placebo-controlled study with an open extension period of 6 months with agomelatine (25 mg).Comparison to functional MRI profiles of healthy volunteers.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-005564-27-FR

Enrollment

Registered

2008-03-25

Start date

2008-07-15

Completion date

Unknown

Last updated

2022-04-04

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: - Patient group : out-patients, Caucasian, females, aged between 25 and 50 years (inclusive), fulfilling DSM-IV-TR criteria for Major Depressive Disorder of moderate or severe intensity. - Healthy volunteers group : Caucasian, females, aged between 25 and 50 years (inclusive). 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: Patient and Healthy volunteers groups : - Unable to be subjected to MRI, - Patients unlikely to fully cooperate in the study, - Pregnant or breastfeeding women.

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess the effect on cerebral activation measured by fMRI in MDD patients;Secondary Objective: - Hamilton Depression Rating Scale (HAM-D) and Clinical Global Impression (CGI), - Leeds Sleep Evaluation Questionnaire (LSEQ), - Metabonomic profiles of MDD patients and HV, - Pharmacogenetic, - To compare fMRI profiles of Major Depressive Disorder patients to fMRI profiles of Healthy Volunteers;Primary end point(s): fMRI	—

Measure

Time frame

Main Objective: To assess the effect on cerebral activation measured by fMRI in MDD patients;Secondary Objective: - Hamilton Depression Rating Scale (HAM-D) and Clinical Global Impression (CGI), - Leeds Sleep Evaluation Questionnaire (LSEQ), - Metabonomic profiles of MDD patients and HV, - Pharmacogenetic, - To compare fMRI profiles of Major Depressive Disorder patients to fMRI profiles of Healthy Volunteers;Primary end point(s): fMRI

—

Countries

France

Outcome results

None listed

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