Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
CL3-20098-083
Study information
Scientific title
Early effect of agomelatine on general interest in outpatients suffering major depressive disorder: a parallel group, randomised, double-blind, multicentre study
Acronym
Study hypothesis
To assess the early effect of agomelatine on general interest in outpatients suffering from major depressive disorder
Please note tht as of 26/11/2012, the anticipated end date for this trial was updated from 30/09/2012 to 30/03/2013.
Ethics approval
Ethics approval was obtained before recruitment of the first participants
Study design
Parallel group randomised double-blind multicentre study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Depression
Intervention
Therapeutic oral doses of agomelatine and therapeutic oral doses of selective serotonin reuptake inhibitors (SSRI) for 12 weeks, a randomised double-blind period
Intervention type
Drug
Phase
Not Applicable
Drug names
Agomelatine
Primary outcome measure
General interest score obtained from the Visual Analogue Scale (VAS) reflecting the item 13 of the QIDS-SR 16 scale
Secondary outcome measures
To provide additional efficacy, safety and tolerability data on agomelatine
Overall trial start date
23/05/2011
Overall trial end date
30/03/2013
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Male or female outpatients
2. Aged between 18 and 65 years (inclusive) at the time of selection
3. Fulfilling Diagnostic and Statistical Manual of Mental Disorders 4th edition, Text Revision (DSM-IV-TR) criteria for current major depressive episode (MDE) < = 12months, of moderate to severe intensity
4. Major depressive episode diagnosis documented using the brief structured Mini-International Neuropsychiatric Interview (M.I.N.I.)
5. Quick Inventory of Depressive Symptomatology Self-Report (QIDS-SR16) item 13 (General interest) > = 2
6. Hamilton Rating Scale for Depression (HAM-D-17) total score > = 22
7. Clinical Global Impression - Severity (CGI-S) (Severity of illness) > = 4 (moderately to severely ill)
8. Requiring an antidepressant treatment
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
300
Participant exclusion criteria
1. Patient fulfilling DSM-IV-TR criteria for a MDE of mild intensity or severe episode with psychotic features,catatonic features or with duration <4 weeks
2. All types of depression other than MDD, according to DSM-IV-TR criteria
3. Marked suicidal intent and/or known suicidal tendencies for the current episode defined as a score of 4 at the item 3 of the HAM-D-17 and/or in the investigator's opinion based on the patient's medical history, previoussuicide attempts, quality of social and familial support
4. Pregnancy, breastfeeding or possibility of becoming pregnant during the study and without an effective contraception
5. Hepatic impairment
6. Severe renal insufficiency
Recruitment start date
23/05/2011
Recruitment end date
30/03/2013
Locations
Countries of recruitment
Romania
Trial participating centre
Spitalul Clinic de Neuropsihiatrie Craiova
Craiova
200317
Romania
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/CL3-20098-083_synopsis_report.pdf
Publication list