|
ISRCTN
|
ISRCTN38378163
|
|
ClinicalTrials.gov identifier
|
|
|
Public 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
|
|
Scientific title
|
|
|
Acronym
|
N/A
|
|
Serial number at source
|
CL2-90098-005
|
|
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 25th January 2008 (ref: 87-07, CPP Ile de France VI).
|
|
Study design
|
Randomised, double-blind, parallel group, placebo-controlled, multicentre, phase II study
|
|
Countries of recruitment
|
France, Czech Republic, Finland, Estonia, Lithuania
|
|
Disease/condition/study domain
|
Major depressive disorder
|
|
Participants - 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)
|
|
Participants - 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
|
|
Anticipated start date
|
25/02/2008
|
|
Anticipated end date
|
30/04/2009
|
|
Status of trial
|
Ongoing
|
|
Patient information material
|
|
|
Target number of participants
|
240
|
|
Interventions
|
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.
|
|
Primary outcome measure(s)
|
Hamilton Rating Scale for Depression (HAM-D), outcome measures will be assessed from baseline to week 24.
|
|
Secondary outcome measure(s)
|
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.
|
|
Sources of funding
|
Institut de Recherches Internationales Servier (France)
|
|
Trial website
|
|
|
Publications
|
|
|
Contact name
|
Prof
Frédéric
Rouillon
|
|
Address
|
Centre Hospitalier de Sainte Anne CMME
100 rue de la santé
|
|
City/town
|
PARIS cedex 14
|
|
Zip/Postcode
|
75674
|
|
Country
|
France
|
|
Email
|
F.ROUILLON@ch-sainte-anne.fr
|
|
Sponsor
|
Institut de Recherches Internationales Servier (France)
|
|
Address
|
6, place des Pléiades
|
|
City/town
|
Courbevoie
|
|
Zip/Postcode
|
92415
|
|
Country
|
France
|
|
Date applied
|
27/03/2008
|
|
Last edited
|
24/04/2008
|
|
Date ISRCTN assigned
|
24/04/2008
|
