Effect of agomelatine on cerebral activity measured by functional magnetic resonance imaging (MRI) in patients with major depressive disorder in comparison to healthy volunteers

ISRCTN	ISRCTN53505070
DOI	https://doi.org/10.1186/ISRCTN53505070
Clinical Trials Information System (CTIS)	2007-005564-27
Protocol serial number	CL2-20098-067
Sponsor	Institut de Recherches Internationales Servier (France)
Funder	Institut de Recherches Internationales Servier (France)

Submission date: 30/10/2008
Registration date: 26/11/2008
Last edited: 20/04/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

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

Contact information

Prof Philippe Fossati
Scientific

CHU Pitié-Salpêtrière - 47
Bd de LHôpital
Paris
75013
France

Study information

Primary study design	Interventional
Study design	Randomised double-blind placebo-controlled study
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Effect of agomelatine on cerebral activity measured by functional magnetic resonance imaging (MRI) in patients with major depressive disorder in comparison to healthy volunteers
Study objectives	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.
Ethics approval(s)	Approval received on the 09/07/2008 by CPP Ile de France VI
Health condition(s) or problem(s) studied	Major depressive disorder
Intervention	Agomelatine 25 mg versus placebo.
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Agomelatine
Primary outcome measure(s)	Functional magnetic resonance imaging.
Key secondary outcome measure(s)	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
Completion date	29/02/2012

Eligibility

Participant type(s)	Mixed
Age group	Adult
Sex	Female
Target sample size at registration	60
Total final enrolment	44
Key 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)
Key exclusion criteria	1. Women of childbearing potential without effective contraception 2. Patients meeting DSM-IV-TR current diagnosis of psychiatric disorder other than MDD
Date of first enrolment	29/09/2008
Date of final enrolment	29/02/2012

Locations

Countries of recruitment

France

Study participating centre

CHU Pitié-Salpêtrière - 47

Paris
75013
France

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
IPD sharing plan	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.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Basic results				No	No
Basic results			20/04/2020	No	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

20/04/2020: The following changes were made to the trial record:
1. Added clinicaltrialsregister.eu link to basic results (scientific).
2. The total final enrollment was added.
18/04/2018: Internal review.
28/03/2018: Publication and dissemination plan and IPD sharing statement updated.
24/01/2018: Publication plan and IPD sharing statement added.
29/11/2017: Results summary added.
02/12/2010: 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 overall trial end date has been extended from 31/03/2010 to 30/12/2011.
10/05/2011: The overall trial end date was extended from 30/09/2011 to 29/02/2012.