Clinical efficacy of Valdoxan® in everyday practice conditions (efficiency)
| ISRCTN | ISRCTN68100949 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN68100949 |
| EudraCT/CTIS number | 2008-008220-32 |
| Secondary identifying numbers | DM4-20098-108 |
- Submission date
- 26/05/2009
- Registration date
- 15/07/2009
- Last edited
- 21/04/2020
- 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
Not provided at time of registration and not expected to be available in the future
Contact information
Prof Pierre-Michel Llorca
Scientific
Scientific
CHU Hôpital Gabriel Montpied
58 rue Montalembert
Clermont-Ferrand
63003
France
Study information
| 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 |
| 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 |
| 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 |
| 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 |
Eligibility
| 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 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 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
Clermont-Ferrand
63003
France
Sponsor information
Institut de Recherches Internationales Servier (France)
Industry
Industry
50 rue Carnot
Suresnes
92284
France
| Website | http://www.servier.com/ |
|---|---|
"ROR" |
https://ror.org/034e7c066 |
Funders
Funder type
Industry
Institut de Recherches Internationales Servier (France)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| 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. |
| 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 | 21/04/2020 | No | No |
Editorial Notes
21/04/2020: 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 plan and IPD sharing statement were updated.
25/01/2018: Publication plan and IPD sharing statement added.
19/12/2017: results summary added.
