Condition category
Mental and Behavioural Disorders
Date applied
27/03/2008
Date assigned
24/04/2008
Last edited
08/11/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration and not expected to be available in the future

Trial website

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

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 below 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), outcome measures will be 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

http://www.servier.com/

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

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes