Additional identifiers
EudraCT number
2006-006540-54
ClinicalTrials.gov number
Protocol/serial number
CL3-20098-063
Study information
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.
Acronym
Study hypothesis
To study the effect of agomelatine on subjective sleep versus Selective Serotonin Reuptake Inhibitor (SSRI).
Ethics approval
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
Study design
Randomised double-blind parallel-group flexible-dose international multicentre comparative phase III study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial 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 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 names
Agomelatine, Selective Serotonin Reuptake Inhibitor (SSRI)
Primary outcome measure
Improvement of subjective sleep, measured by sleep score compared to SSRI
Secondary outcome measures
1. Evaluation of depression (Hamilton Depression [HAM-D] scale)
2. Evaluation of daytime drowsiness
Overall trial start date
22/05/2007
Overall trial end date
15/04/2009
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
300
Total final enrolment
324
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, all other psychiatric disorders
Recruitment start date
22/05/2007
Recruitment end date
15/04/2009
Locations
Countries of recruitment
Australia, Brazil, Canada, France, Russian Federation, South Africa, United Kingdom
Trial participating centre
CHU de Bicêtre - 78
Le Kremlin Bicentre
94275
France
Sponsor information
Organisation
Institut de Recherches Internationales Servier (France)
Sponsor details
50 rue Carnot
Suresnes
92284
France
Sponsor type
Industry
Website
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.
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.
Intention to publish date
Participant level data
Available on request
Basic results (scientific)
http://clinicaltrials.servier.com/wp-content/uploads/CL3-20098-063_synopsis_report.pdf
https://www.clinicaltrialsregister.eu/ctr-search/trial/2006-006540-54/results (added 21/04/2020)
Publication list