Condition category
Mental and Behavioural Disorders
Date applied
26/05/2009
Date assigned
15/07/2009
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 Pierre-Michel Llorca

ORCID ID

Contact details

CHU Hôpital Gabriel Montpied 58 rue Montalembert
Clermont-Ferrand
63003
France

Additional identifiers

EudraCT number

2008-008220-32

ClinicalTrials.gov number

Protocol/serial number

DM4-20098-108

Study information

Scientific title

Acronym

Etude Valdoxan® D-Change

Study hypothesis

Clinical efficiency of Valdoxan® after 6 weeks of treatment.

Please note that as of 26/11/2012 the anticipated end date for this study has been updated from 30/04/2010 to 30/06/2010.

Ethics approval

Ethics approval was obtained before recruitment of the first participants

Study design

Phase IV multicentre open interventional clinical study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Condition

Major depressive episode

Intervention

Agomelatine 25 or 50 mg over a 6-week period.

Intervention type

Drug

Phase

Phase IV

Drug names

Valdoxan®

Primary outcome measures

Assessment of the response to the treatment based on Clinical Global Impression Improvement (CGI-I) Scale, Patient Global Impression Improvement (PGI-I) Scale, Leeds Sleep Evaluation Questionnaire (LSEQ) and patients wish to continue the study treatment at week 6.

Secondary outcome measures

1. Sheehan Disability Scale (SDS) from baseline to week 6
2. MAThyS from baseline to week 6
3. CGI-EI from week 2 to week 6
4. Safety from baseline to week 6

Overall trial start date

20/04/2009

Overall trial end date

30/06/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients older than 18 years (inclusive), either sex
2. Out-patients fulfilling Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) criteria for major depressive disorder

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

4000

Participant exclusion criteria

Women of childbearing potential without effective contraception

Recruitment start date

20/04/2009

Recruitment end date

30/06/2010

Locations

Countries of recruitment

France

Trial participating centre

CHU Hôpital Gabriel Montpied 58 rue Montalembert
Clermont-Ferrand
63003
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