A study to determine the maintenance of efficacy of agomelatine to prevent relapse in out-patients with major depressive disorder. A 8 to 10 weeks open period treatment with agomelatine followed by 24 weeks randomised double-blind period, placebo-controlled, parallel groups and 20 weeks of optional double-blind treatment period.
| ISRCTN | ISRCTN53193024 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN53193024 |
| Clinical Trials Information System (CTIS) | 2004-003981-13 |
| Protocol serial number | CL3-20098-041 |
| Sponsor | Institut de Recherches Internationales Servier (France) |
| Funder | Institut de Recherches Internationales Servier (France) |
- Submission date
- 06/02/2007
- Registration date
- 16/03/2007
- Last edited
- 28/03/2018
- 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 Frederic Rouillon
Scientific
Scientific
Hôpital Albert Chenevier
40 rue de Mesly
Créteil
94000
France
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised double-blind parallel group study |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | A study to determine the maintenance of efficacy of agomelatine (25 mg to 50 mg) to prevent relapse in out-patients with Major Depressive Disorder. A 8 to 10 weeks open period treatment with agomelatine (25 mg to 50 mg) followed by 24 weeks randomised double-blind period, placebo-controlled, parallel groups and 20 weeks of optional double-blind treatment period. |
| Study objectives | To assess the efficacy of agomelatine in the prevention of depressive relapse, in ambulatory patients suffering from major depressive disorder |
| Ethics approval(s) | Sub-Committee on Medical Research Ethics (TUJIKA) of the National Advisory Board on Health Care Ethics, Finland, 01/11/2004 |
| Health condition(s) or problem(s) studied | Major depressive disorder |
| Intervention | A 8- to 10-week open treatment period with agomelatine followed by 24-week randomised double-blind period, placebo-controlled, parallel groups and 20 weeks of optional double-blind treatment period |
| Intervention type | Drug |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Agomelatine |
| Primary outcome measure(s) |
Efficacy in the prevention of depressive relapse, measured by Hamilton Depression Rating Scale (HAMD) - questionnaire |
| Key secondary outcome measure(s) |
Safety parameters, meausred by Adverse Event reporting |
| Completion date | 30/06/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 500 |
| Key inclusion criteria | 1. Aged 18 to 65 years 2. Male or female 3. Out-patients 4. Requiring an antidepressant treatment |
| Key exclusion criteria | 1. All types of depression other than major depressive disorder 2. Severe or uncontrolled organic disease 3. Pregnant or breastfeeding women |
| Date of first enrolment | 09/02/2005 |
| Date of final enrolment | 30/06/2007 |
Locations
Countries of recruitment
- United Kingdom
- Australia
- Finland
- France
- South Africa
Study participating centre
Hôpital Albert Chenevier - 40 rue de Mesly
Créteil
94000
France
94000
France
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 | 01/08/2009 | Yes | No | |
| Results article | results | 01/01/2013 | Yes | No | |
| Basic results | No | No | |||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
28/03/2018: Publication plan and IPD sharing statement amended.
25/01/2018: Publication plan and IPD sharing statement added.
18/12/2017: results summary and publication reference added.
