Effects of agomelatine on sleep electroencephalogram parameters compared to selective serotonin reuptake inhibitors in patients with major depressive disorder: a six-week randomised, double-blind parallel group study versus comparator, followed by a double-blind optional treatment extension period up to six months
| ISRCTN | ISRCTN44737909 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN44737909 |
| EudraCT/CTIS number | 2006-004716-48 |
| Secondary identifying numbers | CL3-20098-056 |
- Submission date
- 03/04/2007
- Registration date
- 22/06/2007
- 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
Dr Maria-Antonia Quera-Salva
Scientific
Scientific
Hôpital Raymond Poincaré
104 boulevard Raymond Poincaré
Garches
92380
France
Study information
| Study design | Six-week randomised double-blind parallel groups study with agomelatine versus SSRI, followed by a double-blind optional treatment extension period up to six months with agomelatine versus SSRI |
|---|---|
| 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 | "Effects of agomelatine (25 to 50 mg/day) on sleep EEG parameters compared to escitalopram in patients with Major Depressive Disorder. A 6-week randomised, double-blind parallel groups study versus comparator, followed by a double-blind optional treatment extension period up to 6 months." |
| Study objectives | To demonstrate that depressed patients treated with agomelatine present a greater improvement in sleep efficiency than patients treated with Selective Serotonin Reuptake Inhibitors (SSRI). |
| Ethics approval(s) | First approval received from the local ethics committee (Comité de Protection des Personnes Ile de France VIII) on the 18/01/2007 (ref: 070101) |
| Health condition(s) or problem(s) studied | Major Depressive Disorder |
| Intervention | Therapeutic doses of agomelatine versus therapeutic doses of SSRI. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Agomelatine, SSRI |
| Primary outcome measure | Effects of agomelatine on sleep Electroencephalogram (EEG) parameters, corresponding to sleep efficiency index, compared to SSRI in patients with major depressive disorder. |
| Secondary outcome measures | 1. Other sleep parameters 2. Subjective sleep parameters 3. Daytime performance 4. Evaluation of depression with the Hamilton rating scale for Depression (HAM-D) scale 5. Safety measured with adverse events, laboratory parameters, and Electrocardiogram (ECG) parameters |
| Overall study start date | 15/02/2007 |
| Completion date | 30/09/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 130 |
| Key inclusion criteria | 1. Aged between 18 and 60 years 2. Male or female 3. Fulfilling Diagnostic and Statistical Manual of mental disorders fourth edition (DSM-IV-TR) 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 |
| Date of first enrolment | 15/02/2007 |
| Date of final enrolment | 30/09/2008 |
Locations
Countries of recruitment
- Australia
- Austria
- Brazil
- Finland
- France
- Germany
- Spain
- Taiwan
- United Kingdom
Study participating centre
Hôpital Raymond Poincaré
Garches
92380
France
92380
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 | 01/09/2011 | Yes | No |
Editorial Notes
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 and publication reference added.
