Efficacy and safety of 3 doses of agomelatine sublingual administration in outpatients with Major Depressive Disorder.

Efficacy and safety of 3 doses (0.25, 0.5 and 1mg/day) of agomelatine sublingual administration over an 8-week treatment period, in out-patients with Major Depressive Disorder. An 8-week randomised, double-blind, fixed dose, international multicentre, placebo-controlled study with parallel groups, followed by an extension double-blind treatment period of 16 weeks.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-014045-92-FI

Enrollment

540

Registered

2009-11-18

Start date

2010-01-12

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: 13.1 Level: PT Classification code 10057840 Term: Major depression System Organ Class: 10037175 - Psychiatric disorders

Interventions

Product Name: S90098 Product Code: S90098 Pharmaceutical Form: Sublingual tablet INN or Proposed INN: AGOMELATINE CAS Number: 138112762 Current Sponsor code: S90098 Concentration unit: mg milligram(s)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Outpatients, male or female, aged between 18 and 70 years (inclusive), fulfilling DSM-IV criteria for Major Depressive Disorder, single or recurrent episode Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 532 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 25

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 ASAT or ALAT or Alkaline Phosphatase (ALP) values = 3 times the upper reference range (ULN) or total bilirubin = 2 times ULN

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess the antidepressant efficacy of 3 doses of S 90098 compared to placebo in out-patients suffering from Major Depressive Disorder;Secondary Objective: To provide pharmacokinetic, efficacy and safety data;Primary end point(s): HAM-D 17-item scale ;Timepoint(s) of evaluation of this end point: ASSE, W0, W2, W4, W6, W8, W12, W16, W20, W24 visits	—

Secondary

Measure	Time frame
Secondary end point(s): Clinical Global Impression scale (CGI) scores Safety measurements;Timepoint(s) of evaluation of this end point: CGI items at ASSE, W0, W2, W4, W6, W8, W12, W16, W20, W24 visits Clinical examination at ASSE, W0, W8 and W24. Laboratory tests at ASSE, W8 and W24, plus at W4 and W12 for liver function parameters. Adverse Events all over the study.	—

Countries

Canada, Czech Republic, Estonia, Finland, France, Mexico, Russian Federation, Sweden

Contacts

Public ContactClinical Studies Department

Institut de Recherches Internationales Servier

clinicaltrials@servier.com+ 33155 72 70 63

Outcome results

None listed

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