Additional identifiers
EudraCT/CTIS number
2006-004716-48
IRAS number
ClinicalTrials.gov number
Secondary identifying numbers
CL3-20098-056
Study information
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."
Acronym
Study hypothesis
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)
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
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Overall study end date
30/09/2008
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type(s)
Patient
Age group
Adult
Lower age limit
18 Years
Sex
Both
Target number of participants
130
Participant 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
Recruitment start date
15/02/2007
Recruitment end date
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
Sponsor information
Organisation
Institut de Recherches Internationales Servier (France)
Sponsor details
50 rue Carnot
Suresnes
92284
France
Sponsor type
Industry
Website
ROR
Funders
Funder type
Industry
Funder name
Institut de Recherches Internationales Servier (France)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
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.
Intention to publish date
Individual participant data (IPD) Intention to share
Yes
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.
IPD sharing plan summary
Available on request
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 |