Efficacy and safety of agomelatine oral administration (25 to 50 mg/day) in elderly patients suffering from major depressive disorder: an 8-week, randomised, double-blind, flexible-dose, parallel groups, placebo-controlled, international, multicentre study followed by an extension double-blind treatment period of 16 weeks
| ISRCTN | ISRCTN57507360 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN57507360 |
| EudraCT/CTIS number | 2009-011795-29 |
| Secondary identifying numbers | CL3-20098-070 |
- Submission date
- 07/04/2010
- Registration date
- 30/04/2010
- 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
Not provided at time of registration and not expected to be available in the future
Contact information
Prof Reinhard Heun
Scientific
Scientific
Radbourne Unit
Derby City General Hospital
Uttoxeter Road
Derby
DE22 3NE
United Kingdom
Study information
| Study design | Randomised double-blind flexible-dose parallel group placebo-controlled international multicentre study, followed by an extension double-blind treatment period |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| 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 agomelatine oral administration (25 to 50 mg/day) in elderly patients suffering from Major Depressive Disorder. A 8-week, randomised, double-blind, flexible-dose, parallel groups, placebo-controlled, international, multicentre study followed by an extension double-blind treatment period of 16 weeks" |
| Study hypothesis | To demonstrate the efficacy of agomelatine compared to placebo using the 17-item Hamilton Rating Scale for Depression (HAM-D-17), after 8 weeks of treatment in elderly out-patients suffering from major depressive disorder. |
| Ethics approval(s) | First Ethics Committee approval obtained on 18/08/2009 in Finland |
| Condition | Major depressive disorder |
| Intervention | Agomelatine 25 or 50 mg versus placebo. 8-week treatment followed by an extension double-blind treatment period of 16 weeks. |
| 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 - 8 period |
| Secondary outcome measures | 1. Clinical Global Impression scale scores, from baseline to week 8 and 24 2. Sheehan Disability Scale scores, from baseline to week 8 and 24 3. Safety from baseline to week 8 and 24 |
| Overall study start date | 04/11/2009 |
| Overall study end date | 31/10/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Both |
| Target number of participants | 210 |
| Participant inclusion criteria | 1. Out-patients of both genders aged more than 65 years 2. Fulfilling Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) criteria for a moderate to severe episode of a recurrent major depressive disorder |
| Participant exclusion criteria | 1. All types of depression other than major depressive disorder recurrent 2. Severe or uncontrolled organic diseases, likely to interfere with the conduct of the study 3. Current diagnosis of neurological disorders |
| Recruitment start date | 04/11/2009 |
| Recruitment end date | 31/10/2011 |
Locations
Countries of recruitment
- Argentina
- England
- Finland
- Mexico
- Portugal
- Romania
- United Kingdom
Study participating centre
Radbourne Unit
Derby
DE22 3NE
United Kingdom
DE22 3NE
United Kingdom
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 | 01/06/2013 | Yes | No | |
| Results article | results | 01/07/2017 | Yes | No |
Editorial Notes
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.
19/12/2017: results summary and publication reference added
