Efficacy and safety of three dose regimens of agomelatine versus placebo given once a day for 6 weeks in out-patients suffering from moderate to severe major depressive disorder
| ISRCTN | ISRCTN10845256 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10845256 |
| EudraCT/CTIS number | 2009-011238-84 |
| Secondary identifying numbers | CL3-20098-069 |
- Submission date
- 09/04/2010
- Registration date
- 18/05/2010
- Last edited
- 18/04/2018
- 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 of protocol
Not provided at time of registration and not expected to be available in the future
Contact information
Dr Ricardo M. Corral
Scientific
Scientific
Cerviño 4634, 5o B
Buenos Aires
BC1425AHQ
Argentina
Study information
| Study design | Randomised double-blind placebo-controlled parallel group study followed by a double-blind optional extension period |
|---|---|
| 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 | Efficacy and safety of three dose regimens of agomelatine (10, 25, 25 - 50 mg) versus placebo given once a day for 6 weeks in out-patients suffering from moderate to severe major depressive disorder: a 6-week randomised, double-blind, placebo-controlled, parallel groups study followed by a double-blind optional 18-week extension period |
| Study objectives | To demonstrate the short term efficacy of at least one of the three dose regimens of agomelatine (versus placebo) using the 17-item Hamilton Rating Scale for Depression (HAM-D-17). |
| Ethics approval(s) | First Ethics Committee approval obtained on 10/06/2009 |
| Health condition(s) or problem(s) studied | Major depressive disorder |
| Intervention | Agomelatine 10, 25 or 50 mg versus placebo for 6 weeks followed by an optional 18-week extension period. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | Agomelatine |
| Primary outcome measure | HAM-D total score, on the week 0 - week 6 period |
| Secondary outcome measures | 1. HAM-D items, from baseline to week 24 2. Clinical Global Impression scale, from baseline to week 6 and 24 3. Sheehan Disability Scale, from baseline to week 6 and 24 4. Hospital Anxiety and Depression Scale, from baseline to week 6 5. Safety from baseline to week 6 and 24 |
| Overall study start date | 28/10/2009 |
| Completion date | 07/04/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 520 |
| Key inclusion criteria | 1. Out-patients of both genders aged between 18 (or legal age) and 65 years of age 2. Fulfilling Diagnostic and Statistical Manual, Fourth Edition, Text Revision (DSM-IV-TR) criteria for major depressive disorder (MDD) of moderate or severe intensity |
| Key exclusion criteria | 1. Women of childbearing potential without effective contraception 2. Other types of depression than MDD 3. Severe or uncontrolled organic diseases, likely to interfere with the conduct of the study |
| Date of first enrolment | 28/10/2009 |
| Date of final enrolment | 07/04/2012 |
Locations
Countries of recruitment
- Argentina
- Bulgaria
- Finland
- Russian Federation
- Slovakia
- Ukraine
Study participating centre
Cerviño 4634, 5o B
Buenos Aires
BC1425AHQ
Argentina
BC1425AHQ
Argentina
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 | |||
| Results article | results | 01/02/2016 | Yes | No |
Editorial Notes
18/04/2018: Internal review.
28/03/2018: Publication plan and IPD sharing statement updated.
18/12/2017: results summary and publication reference added.
