Evaluation of efficacy and clinical benefit of agomelatine in patients with major depressive disorder compared to serotonin-norepinephrine reuptake inhibitor (SNRI)
| ISRCTN | ISRCTN96725312 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN96725312 |
| Clinical Trials Information System (CTIS) | 2008-004642-92 |
| Protocol serial number | CL3-20098-062 |
| Sponsor | Institut de Recherches Internationales Servier (France) |
| Funder | Institut de Recherches Internationales Servier (France) |
- Submission date
- 07/04/2009
- Registration date
- 08/05/2009
- Last edited
- 21/04/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Not provided at time of registration and not expected to be available in the future
Contact information
Scientific
50 rue Carnot
Suresnes
92284
France
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised double-blind parallel-group international multicentre active-controlled phase III study |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Evaluation of efficacy and clinical benefit of agomelatine (25 to 50 mg/day) over a 6-month treatment period in patients with Major Depressive Disorder.A randomised, double-blind, international multicentre study with parallel groups versus duloxetine (60 mg/day).Twenty-four weeks of treatment. |
| Study objectives | Long-term antidepressant efficacy of agomelatine compared to serotonin-norepinephrine reuptake inhibitor (SNRI) over a 6-month period. |
| Ethics approval(s) | Ethics approval was obtained before recruitment of the first participants |
| Health condition(s) or problem(s) studied | Major depressive disorder |
| Intervention | Agomelatine 25 or 50 mg versus SNRI over a 6-month period. |
| Intervention type | Drug |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | Agomelatine |
| Primary outcome measure(s) |
Hamilton Rating Scale for Depression (HAM-D) total score, from baseline to week 24. |
| Key secondary outcome measure(s) |
1. HAM-D items, from baseline to week 24 |
| Completion date | 31/10/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 400 |
| Total final enrolment | 418 |
| Key inclusion criteria | 1. Aged between 18 and 65 years, either sex 2. Out-patients fulfilling Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) criteria for major depressive disorder |
| Key exclusion criteria | Women of childbearing potential without effective contraception |
| Date of first enrolment | 29/04/2009 |
| Date of final enrolment | 31/10/2010 |
Locations
Countries of recruitment
- United Kingdom
- Australia
- Brazil
- Canada
- France
- Greece
- Hungary
- Italy
- Portugal
- South Africa
- Spain
Study participating centre
92284
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 | 21/04/2020 | No | No | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
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 updated.
25/01/2018: Publication plan and IPD sharing statement added.
18/12/2017: results summary added.
