Contact information
Type
Scientific
Primary contact
Prof Frédéric Rouillon
ORCID ID
Contact details
Centre Hospitalier de Sainte Anne CMME
100 rue de la santé
PARIS cedex 14
75674
France
-
F.ROUILLON@ch-sainte-anne.fr
Additional identifiers
EudraCT number
2007-003312-65
ClinicalTrials.gov number
Protocol/serial number
CL2-90098-005
Study information
Scientific title
Efficacy and safety of two doses of S 90098 (1 and 2 mg/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
Acronym
Study hypothesis
To assess the antidepressant efficacy of S 90098 in outpatients suffering from major depressive disorder (MDD).
Ethics approval
First ethics committee approval in France on 25/01/2008 (ref: 87-07, CPP Ile de France VI).
Study design
Randomised, double-blind, parallel group, placebo-controlled, multicentre, phase II study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Major depressive disorder
Intervention
Eight-week randomised treatment period with agomelatine orodispersible 1 or 2 mg/day versus placebo followed by an extension double-blind period for 16 weeks.
Intervention type
Drug
Phase
Phase II
Drug names
S 90098
Primary outcome measures
Hamilton Rating Scale for Depression (HAM-D), assessed from baseline to week 24
Secondary outcome measures
1. Safety
2. Sleep (Leeds Sleep Evaluation Questionnaire [LSEQ])
3. Long term efficacy
4. Pharmacokinetic
Outcome measures will be assessed from baseline to week 24.
Overall trial start date
25/02/2008
Overall trial end date
30/04/2009
Reason abandoned
Eligibility
Participant inclusion criteria
1. Between 18 (or minimum legal age) and 70 years of age
2. Out-patients of both genders
3. Fulfilling Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition (DSM-IV) criteria for major depressive disorder (MDD)
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
240
Participant exclusion criteria
1. Women of childbearing potential without effective contraception
2. Patients meeting DSM-IV-TR current diagnosis of psychiatric disorder other than MDD
3. Any clinically relevant abnormality detected during the physical examination, electrocardiogram (ECG) or laboratory tests likely to interfere with the study conduct or evaluations
Recruitment start date
25/02/2008
Recruitment end date
30/04/2009
Locations
Countries of recruitment
Czech Republic, Estonia, Finland, France, Lithuania
Trial participating centre
Centre Hospitalier de Sainte Anne CMME
PARIS cedex 14
75674
France
Sponsor information
Organisation
Institut de Recherches Internationales Servier (France)
Sponsor details
50 rue Carnot
Suresnes
92284
France
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Institut de Recherches Internationales Servier (France)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Publication plan:
Summary results are published in https://clinicaltrials.servier.com.
IPD sharing statement:
The datasets generated during and/or analysed during the current study will be available upon request from https://clinicaltrials.servier.com if a Marketing Authorisation has been granted after 1st January 2014.
Intention to publish date
Participant level data
Available on request
Results - basic reporting
http://clinicaltrials.servier.com/wp-content/uploads/CL2-90098-005_synopsis_report.pdf
Publication summary