Efficacy and safety of 2 doses of S 90098 (1 and 2mg/day), sublingual formulation for 8 weeks 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 for 16 weeks.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-003312-65-FR

Enrollment

240

Registered

2007-10-30

Start date

2008-01-25

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: S90098 Product Code: S90098 Pharmaceutical Form: Orodispersible tablet Current Sponsor code: S90098 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1-

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 assess the antidepressant efficacy of 2 doses of S 90098 compared to placebo;Secondary Objective: To provide short-term and long-term safety data of S90098, to study the effects on subjective sleep and daytime sleepiness, to provide long-term efficacy data and to provide pharmacokinetic data.;Primary end point(s): HAM-D 17-item	—

Countries

Czech Republic, Estonia, Finland, France, Lithuania

Outcome results

None listed

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