Condition category
Mental and Behavioural Disorders
Date applied
30/10/2008
Date assigned
26/11/2008
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 Philippe Fossati

ORCID ID

Contact details

CHU Pitié-Salpêtrière - 47
Bd de L’Hôpital
Paris
75013
France

Additional identifiers

EudraCT number

2007-005564-27

ClinicalTrials.gov number

Protocol/serial number

CL2-20098-067

Study information

Scientific title

Acronym

Study hypothesis

To assess the effect of agomelatine compared to placebo, on cerebral activation measured by functional magnetic resonance imaging (fMRI) in major depressive disorder patients. Comparison to functional MRI profiles of healthy volunteers.

Please note that as of 02/12/10 this record has been updated to include changes to the inclusion criteria. More details can be found in the relevant field with the above update date. Please also note that the end date of this trial has been extended from 31/03/10 to 30/12/11.

As of 10/05/2011 the anticipated end date for this trial has been extended from 30/09/2011 to 29/02/2012.

Ethics approval

Approval received on the 09/07/2008 by CPP Ile de France VI

Study design

Randomised double-blind placebo-controlled 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

Agomelatine 25 mg versus placebo.

Intervention type

Drug

Phase

Not Specified

Drug names

Agomelatine

Primary outcome measures

Functional magnetic resonance imaging.

Secondary outcome measures

1. Functional magnetic resonance imaging
2. Hamilton Rating Scale for Depression (HAM-D), Time point: baseline to week 24
3. Clinical Global Impression (CGI), Time point: baseline to week 24
4. Sleep (Leeds Sleep Evaluation Questionnaire [LSEQ]), Time point: baseline to week 24
5. Safety, Time point: baseline to week 24

Overall trial start date

29/09/2008

Overall trial end date

29/02/2012

Reason abandoned

Eligibility

Participant inclusion criteria

Amended 02/12/2010:
1. Healthy volunteers and patients: between 25 and 53 years, female

initial information at time of registration
1. Healthy volunteers and patients: between 25 and 50 years, female
2. Out-patients fulfilling Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition (DSM-IV) criteria for major depressive disorder (MDD)

Participant type

Healthy volunteer

Age group

Adult

Gender

Female

Target number of participants

60

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

Recruitment start date

29/09/2008

Recruitment end date

29/02/2012

Locations

Countries of recruitment

France

Trial participating centre

CHU Pitié-Salpêtrière - 47
Paris
75013
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