Additional identifiers
EudraCT number
2009-011238-84
ClinicalTrials.gov number
Protocol/serial number
CL3-20098-069
Study information
Scientific title
Efficacy and safety of three dose regimens of agomelatine (10, 25, 25 - 50 mg) versus placebo given once a day for 6 weeks in out-patients suffering from moderate to severe major depressive disorder: a 6-week randomised, double-blind, placebo-controlled, parallel groups study followed by a double-blind optional 18-week extension period
Acronym
Study hypothesis
To demonstrate the short term efficacy of at least one of the three dose regimens of agomelatine (versus placebo) using the 17-item Hamilton Rating Scale for Depression (HAM-D-17).
Ethics approval
First Ethics Committee approval obtained on 10/06/2009
Study design
Randomised double-blind placebo-controlled parallel group study followed by a double-blind optional extension period
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
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
Agomelatine 10, 25 or 50 mg versus placebo for 6 weeks followed by an optional 18-week extension period.
Intervention type
Drug
Phase
Phase III
Drug names
Agomelatine
Primary outcome measure
HAM-D total score, on the week 0 - week 6 period
Secondary outcome measures
1. HAM-D items, from baseline to week 24
2. Clinical Global Impression scale, from baseline to week 6 and 24
3. Sheehan Disability Scale, from baseline to week 6 and 24
4. Hospital Anxiety and Depression Scale, from baseline to week 6
5. Safety from baseline to week 6 and 24
Overall trial start date
28/10/2009
Overall trial end date
07/04/2012
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Out-patients of both genders aged between 18 (or legal age) and 65 years of age
2. Fulfilling Diagnostic and Statistical Manual, Fourth Edition, Text Revision (DSM-IV-TR) criteria for major depressive disorder (MDD) of moderate or severe intensity
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
520
Participant exclusion criteria
1. Women of childbearing potential without effective contraception
2. Other types of depression than MDD
3. Severe or uncontrolled organic diseases, likely to interfere with the conduct of the study
Recruitment start date
28/10/2009
Recruitment end date
07/04/2012
Locations
Countries of recruitment
Argentina, Bulgaria, Finland, Russian Federation, Slovakia, Ukraine
Trial participating centre
Cerviño 4634, 5o B
Buenos Aires
BC1425AHQ
Argentina
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/CL3-20098-069_synopsis_report.pdf
Publication list
2016 results in: https://www.ncbi.nlm.nih.gov/pubmed/26708320