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 |
| EudraCT/CTIS number | 2008-004642-92 |
| Secondary identifying numbers | CL3-20098-062 |
- 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
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
Mrs Christine Marey
Scientific
Scientific
50 rue Carnot
Suresnes
92284
France
Study information
| Study design | Randomised double-blind parallel-group international multicentre active-controlled phase III study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 hypothesis | 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 |
| Condition | Major depressive disorder |
| Intervention | Agomelatine 25 or 50 mg versus SNRI over a 6-month period. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | Agomelatine |
| Primary outcome measure | Hamilton Rating Scale for Depression (HAM-D) total score, from baseline to week 24. |
| Secondary outcome measures | 1. HAM-D items, from baseline to week 24 2. Clinical Global Impression scale, from baseline to week 24 3. Pittsburgh Sleep Quality Index, from baseline to week 24 4. Leeds Sleep Evaluation Questionnaire, from week 1 to week W2 5. Sheehan Disability Scale, from baseline to week 24 6. Safety from baseline to week 24 |
| Overall study start date | 29/04/2009 |
| Overall study end date | 31/10/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 400 |
| Total final enrolment | 418 |
| Participant 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 |
| Participant exclusion criteria | Women of childbearing potential without effective contraception |
| Recruitment start date | 29/04/2009 |
| Recruitment end date | 31/10/2010 |
Locations
Countries of recruitment
- Australia
- Brazil
- Canada
- France
- Greece
- Hungary
- Italy
- Portugal
- South Africa
- Spain
- United Kingdom
Study participating centre
50 Rue Carnot
Suresnes
92284
France
92284
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 updated.
25/01/2018: Publication plan and IPD sharing statement added.
18/12/2017: results summary added.
