Efficacy of agomelatine given orally on the quality of remission in elderly depressed patients, after a 12-week treatment period. A randomised, double-blind, flexible-dose international multicentre study with parallel groups versus SSRI drug. Twelve-week treatment plus optional continuation for 12 weeks.
| ISRCTN | ISRCTN68222771 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN68222771 |
| EudraCT/CTIS number | 2005-002388-95 |
| Secondary identifying numbers | CL3-20098-048 |
- Submission date
- 24/01/2006
- Registration date
- 31/03/2006
- 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 Thierry Bougerol
Scientific
Scientific
CHU de Grenoble-Hopital Sud
Psychiatrie de l'Adulte
BP 185
Cedex 09
Grenoble
38042
France
Study information
| Study design | Randomised double-blind flexible-dose international multicentre study with parallel groups versus SSRI drug |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| 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 of agomelatine (25 to 50 mg/day) given orally on quality of remission in elderly depressed patients, after a 12-week treatment period.A randomised, double-blind, flexible-dose international multicentre study with parallel groups versus paroxetine (20 to 30 mg/day).Twelve-week treatment plus optional continuation for 12 weeks. |
| Study objectives | To show the efficacy of agomelatine in improving the quality of remission in elderly depressed patients. On 26/11/2012 the anticipated end date of this trial was updated from 30/10/2007 to 30/04/2008. |
| Ethics approval(s) | First approved by the Ethical Committee of Clinical Investigations, Clinical Hospital of San Carlos (Comite Etico de Investigacion Clinica, Hospital Clinico, San Carlos) on 05/08/2005 in Spain, reference number: 05/165-R |
| Health condition(s) or problem(s) studied | Major depressive disorder |
| Intervention | Agomelatine versus SSRI drug |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Agomelatine |
| Primary outcome measure | Quality of sleep |
| Secondary outcome measures | 1. Other sleep patterns 2. Quality of life 3. Daytime drowsiness 4. Residual symptoms of depression |
| Overall study start date | 07/10/2005 |
| Completion date | 30/04/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 400 |
| Key inclusion criteria | Out-patients aged at least 60 years with recurrent major depressive episode according to diagnostic and statistical manual of mental disorders (DSM) IV |
| Key exclusion criteria | 1. Patients treated with electroconvulsive therapy (ECT) within the last three months 2. Insight-oriented and structured psychotherapy started within the three months before inclusion 3. Light-therapy started within two weeks before inclusion 4. Current diagnosis of neurological disorders 5. Cognitive dysfunction 6. Severe or uncontrolled organic disease, likely to interfere with the conduct of the study |
| Date of first enrolment | 07/10/2005 |
| Date of final enrolment | 30/04/2008 |
Locations
Countries of recruitment
- Austria
- Belgium
- Denmark
- France
- Hungary
- Italy
- Norway
- Poland
- Portugal
- Spain
Study participating centre
CHU de Grenoble-Hopital Sud
Grenoble
38042
France
38042
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 | |||
| Results article | results | 01/01/2013 | Yes | No |
Editorial Notes
18/04/2018: Internal review.
28/03/2018: Publication and dissemination plan and IPD sharing statement updated.
25/01/2018: Publication plan and IPD sharing statement added.
18/12/2017: results summary and publication reference added.
