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 |
| Clinical Trials Information System (CTIS) | 2009-011795-29 |
| Protocol serial number | CL3-20098-070 |
| Sponsor | Institut de Recherches Internationales Servier (France) |
| Funder | Institut de Recherches Internationales Servier (France) |
- 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 of protocol
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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised double-blind flexible-dose parallel group placebo-controlled international multicentre study, followed by an extension double-blind treatment period |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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 objectives | 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 |
| Health condition(s) or problem(s) studied | 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 |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | Agomelatine |
| Primary outcome measure(s) |
HAM-D total score, on the week 0 - 8 period |
| Key secondary outcome measure(s) |
1. Clinical Global Impression scale scores, from baseline to week 8 and 24 |
| Completion date | 31/10/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | All |
| Target sample size at registration | 210 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 04/11/2009 |
| Date of final enrolment | 31/10/2011 |
Locations
Countries of recruitment
- United Kingdom
- England
- Argentina
- Finland
- Mexico
- Portugal
- Romania
Study participating centre
Radbourne Unit
Derby
DE22 3NE
United Kingdom
DE22 3NE
United Kingdom
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? |
|---|---|---|---|---|---|
| Results article | results | 01/06/2013 | Yes | No | |
| Results article | results | 01/07/2017 | Yes | No | |
| Basic results | No | No | |||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
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
