Efficacy and safety of agomelatine (25 mg/day with potential adjustment to 50 mg) given orally for eight weeks in out-patients with severe major depressive disorder: a randomised double-blind, parallel groups, international study versus selective serotonin reuptake inhibitor (SSRI) with a double-blind extension period of 16 weeks
| ISRCTN | ISRCTN19313268 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN19313268 |
| Clinical Trials Information System (CTIS) | 2004-004008-19 |
| Protocol serial number | CL3-20098-045 |
| Sponsor | Institut de Recherches Internationales Servier (France) |
| Funder | Institut de Recherches Internationales Servier (France) |
- Submission date
- 29/07/2008
- Registration date
- 19/08/2008
- 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 Anthony Hale
Scientific
Scientific
Eastern and Costal Headquarters
St Martin's Hospital
Littlebourne Road
Canterbury
Kent
CT1 1AZ
United Kingdom
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 and safety of agomelatine (25 mg/day with potential adjustment to 50 mg) given orally for 8 weeks in out-patients with severe Major Depressive Disorder. A randomised double-blind, parallel groups, international study versus fluoxetine (20 mg/day with potential adjustment to 40 mg) with a double-blind extension period of 16 weeks. |
| Study objectives | To assess the agomelatine superiority to selective serotonin reuptake inhibitor (SSRI) after an eight-week treatment in out-patients suffering from severe major depressive disorder. |
| Ethics approval(s) | Ethics approval was obtained before recruitment of the first participants |
| Health condition(s) or problem(s) studied | Major depressive disorder |
| Intervention | 1. Agomelatine: 25 mg/day with potential adjustment to 50 mg, given orally for eight weeks 2. Selective serotonin reuptake inhibitor (SSRI) Followed by an extension double-blind period for 16 weeks. |
| Intervention type | Drug |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | Agomelatine, selective serotonin reuptake inhibitor (SSRI) |
| Primary outcome measure(s) |
Hamilton Depression Rating Scale (HAM-D) total score will be assessed from baseline to week 24. |
| Key secondary outcome measure(s) |
1. Clinical Global Impressions (CGI) Scale |
| Completion date | 14/03/2008 |
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. Fulfilling Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition (DSM-IV) criteria for major depressive disorder |
| Key exclusion criteria | 1. Pregnancy, breastfeeding or possibility of becoming pregnant during the study 2. All types of depression other than major depressive disorder 3. Severe or uncontrolled organic disease |
| Date of first enrolment | 06/10/2005 |
| Date of final enrolment | 14/03/2008 |
Locations
Countries of recruitment
- United Kingdom
- England
- Argentina
- Brazil
- Italy
- Spain
Study participating centre
Eastern and Costal Headquarters
Kent
CT1 1AZ
United Kingdom
CT1 1AZ
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 | 01/11/2010 | 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.
