Additional identifiers
EudraCT/CTIS number
2008-008220-32
IRAS number
ClinicalTrials.gov number
Protocol/serial number
DM4-20098-108
Study information
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
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(s)
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
Study setting(s)
Other
Study type
Treatment
Patient information sheet
Condition
Major depressive episode
Intervention
Agomelatine 25 or 50 mg over a 6-week period.
Intervention type
Drug
Pharmaceutical study type(s)
Phase
Phase IV
Drug/device/biological/vaccine name(s)
Valdoxan®
Primary outcome measure
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 study start date
20/04/2009
Overall study end date
30/06/2010
Reason abandoned (if study stopped)
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(s)
Patient
Age group
Adult
Lower age limit
18 Years
Sex
Both
Target number of participants
4,000
Total final enrolment
2938
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
Study 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
ROR
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
Summary results are published in https://clinicaltrials.servier.com.
For interventional Phase III studies ending after the 1st January 2014, the results are/will be published in scientific literature.
Intention to publish date
Individual participant data (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.
IPD sharing plan summary
Available on request
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | No | No | |||
| Basic results | 21/04/2020 | No | No |