Efficacy of agomelatine given orally on improvement of subjective sleep in patients with major depressive disorder: a randomised, double-blind, flexible-dose international multicentre study with parallel groups versus Selective Serotonin Reuptake Inhibitor (SSRI) twelve week treatment plus double-blind extension for 12 weeks
| ISRCTN | ISRCTN55250367 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN55250367 |
| Clinical Trials Information System (CTIS) | 2006-006540-54 |
| Protocol serial number | CL3-20098-063 |
| Sponsor | Institut de Recherches Internationales Servier (France) |
| Funder | Institut de Recherches Internationales Servier (France) |
- Submission date
- 15/05/2007
- Registration date
- 12/07/2007
- Last edited
- 21/04/2020
- 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 Emmanuelle Corruble
Scientific
Scientific
CHU de Bicêtre
78 rue du Général Leclerc
Le Kremlin Bicetre
94275
France
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised double-blind parallel-group flexible-dose international multicentre comparative phase III study |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Efficacy of agomelatine (25 to 50 mg/day) given orally on improvement of subjective sleep in patients with Major Depressive Disorder. A randomised, double-blind, flexible-dose international multicentre study with parallel groups versus escitalopram (10 to 20mg/day). Twelve-week treatment plus double-blind extension for 12 weeks. |
| Study objectives | To study the effect of agomelatine on subjective sleep versus Selective Serotonin Reuptake Inhibitor (SSRI). |
| Ethics approval(s) | First ethics committee approval in Brazil on 01/03/2007 from Comitê de Etica em Pesquisa do Instituto de Providencia dos Servidores do Estado de Minas Gerais - IPSEMG/ Hospital Governador Israël Pinheiro HGIP ; registration number: 245/07 ; in Belo Horizonte |
| Health condition(s) or problem(s) studied | Major Depressive Disorder |
| Intervention | Therapeutic oral doses of agomelatine versus therapeutic oral doses of SSRI - twelve week treatment plus double-blind extension for twelve weeks. |
| Intervention type | Drug |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | Agomelatine, Selective Serotonin Reuptake Inhibitor (SSRI) |
| Primary outcome measure(s) |
Improvement of subjective sleep, measured by sleep score compared to SSRI |
| Key secondary outcome measure(s) |
1. Evaluation of depression (Hamilton Depression [HAM-D] scale) |
| Completion date | 15/04/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 300 |
| Total final enrolment | 324 |
| Key inclusion criteria | 1. Aged between 18 to 70 years (included) 2. Male or female 3. Fulfilling Diagnostic and Statistical Manual of mental disorders fourth edition (DSM-IV) criteria for major depressive disorder |
| Key exclusion criteria | 1. Women of childbearing potential without effective contraception as well as pregnant or breastfeeding women 2. All types of depression other than major depressive disorder, all other psychiatric disorders |
| Date of first enrolment | 22/05/2007 |
| Date of final enrolment | 15/04/2009 |
Locations
Countries of recruitment
- United Kingdom
- Australia
- Brazil
- Canada
- France
- Russian Federation
- South Africa
Study participating centre
CHU de Bicêtre - 78
Le Kremlin Bicentre
94275
France
94275
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? |
|---|---|---|---|---|---|
| Basic results | No | No | |||
| Basic results | 21/04/2020 | No | No | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
21/04/2020: The following changes were made to the trial record:
1. Added clinicaltrialsregister.eu link to basic results (scientific).
2. The total final enrollment was added.
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.
18/12/2017: results summary added.`
