Efficacy of agomelatine given orally on rest/activity circadian rhythms in outpatients with major depressive disorder: a randomised, double-blind international study with parallel groups versus Selective Serotonin Reuptake Inhibitor (SSRI). Six-week treatment plus optional continuation for 18 weeks.
| ISRCTN | ISRCTN49376288 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN49376288 |
| Clinical Trials Information System (CTIS) | 2004-004009-10 |
| Protocol serial number | CL3-20098-046 |
| Sponsor | Institut de Recherches Internationales Servier (France) |
| Funder | Institut de Recherches Internationales Servier (France) |
- Submission date
- 04/05/2007
- Registration date
- 08/06/2007
- 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 Franck Bayle
Scientific
Scientific
Centre Hospitalier Sainte-Anne
1 rue Cabanis
Paris cedex 14
75674
France
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised double-blind parallel-group comparative phase III study |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Efficacy of agomelatine (25 mg/day with potential adjustment to 50 mg) given orally on rest/activity circadian rhythms in outpatients with Major Depressive Disorder. A randomized, double-blind international study with parallel groups versus sertraline (50 mg/day with potential adjustment to 100 mg). Six-week treatment plus optional continuation for 18 weeks. |
| Study objectives | To demonstrate that agomelatine improves rest/activity circadian rhythms faster than Selective Serotonin Reuptake Inhibitor (SSRI) in outpatients suffering from major depressive disorder. |
| Ethics approval(s) | First ethics committee approval in France received from the local ethics board (Comités de Consultation pour la Protection des Personnes se prêtant à la Recherche Biomédicale [CCPPRB] Paris-Broussais) on the 15/03/2005 (ref: 2005-006) |
| Health condition(s) or problem(s) studied | Major depressive disorder |
| Intervention | Agomelatine versus SSRI |
| Intervention type | Drug |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | Agomelatine, Selective Serotonin Reuptake Inhibitor (SSRI) |
| Primary outcome measure(s) |
Efficacy assessed by actimetry recording |
| Key secondary outcome measure(s) |
1. Depression |
| Completion date | 30/09/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 60 Years |
| Sex | All |
| Target sample size at registration | 300 |
| Key inclusion criteria | 1. Male or female 2. Out-patients 3. Aged of 18 to 60 years (inclusive) 4. Fulfilling Diagnostic and Statistical Manual of Mental Disorders - fourth edition (DSM-IV) criteria for major depressive disorder 5. Requiring an antidepressant treatment |
| Key exclusion criteria | 1. Pregnant or breastfeeding, women of childbearing potential without effective contraception 2. All types of depression other than major depressive disorder 3. Severe or uncontrolled disease |
| Date of first enrolment | 01/04/2005 |
| Date of final enrolment | 30/09/2007 |
Locations
Countries of recruitment
- Austria
- France
- Germany
- Italy
- Poland
- Spain
Study participating centre
Centre Hospitalier Sainte-Anne
Paris cedex 14
75674
France
75674
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 | 01/02/2010 | 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 and dissemination plan and IPD sharing statement updated.
25/01/2018: Publication plan and IPD sharing statement added.
18/12/2017: results summary added.
