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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ISRCTN
Last refreshed on:	4 May 2020
Main ID:	ISRCTN68100949
Date of registration:	15/07/2009
Prospective Registration:	No
Primary sponsor:	Institut de Recherches Internationales Servier (France)
Public title:	Clinical efficacy of Valdoxan® in everyday practice conditions (efficiency)
Scientific title:	Clinical efficacy of VALDOXAN in everyday practice conditions (efficiency) in depressed patients, on a treatment-naive or switch basis. Phase-IV, multicentre, open, interventional clinical study. VALDOXAN D-CHANGE Study
Date of first enrolment:	20/04/2009
Target sample size:	4000
Recruitment status:	Completed
URL:	http://isrctn.com/ISRCTN68100949
Study type:	Interventional
Study design:	Phase IV multicentre open interventional clinical study (Treatment)
Phase:	Phase IV

Countries of recruitment
France

Contacts

Name:
Address:
Telephone:
Email:
Affiliation:

Name:	Pierre-Michel Llorca
Address:	CHU Hôpital Gabriel Montpied 58 rue Montalembert 63003 Clermont-Ferrand France
Telephone:
Email:
Affiliation:

Key inclusion & exclusion criteria

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

Exclusion criteria: Women of childbearing potential without effective contraception

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Major depressive episode
Mental and Behavioural Disorders
Depressive episode

Intervention(s)

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

Primary Outcome(s)

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(s)

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

Secondary ID(s)

2008-008220-32

DM4-20098-108

Source(s) of Monetary Support

Institut de Recherches Internationales Servier (France)

Secondary Sponsor(s)

Ethics review

Status:
Approval date:
Contact:

Ethics approval was obtained before recruitment of the first participants

Results

Results available:	Yes
Date Posted:
Date Completed:	30/06/2010
URL:

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