Additional identifiers
EudraCT/CTIS number
2004-004008-19
IRAS number
ClinicalTrials.gov number
Protocol/serial number
CL3-20098-045
Study information
Scientific title
Efficacy and safety of agomelatine (25 mg/day with potential adjustment to 50 mg) given orally for 8 weeks in out-patients with severe Major Depressive Disorder. A randomised double-blind, parallel groups, international study versus fluoxetine (20 mg/day with potential adjustment to 40 mg) with a double-blind extension period of 16 weeks.
Acronym
Study hypothesis
To assess the agomelatine superiority to selective serotonin reuptake inhibitor (SSRI) after an eight-week treatment in out-patients suffering from severe major depressive disorder.
Ethics approval(s)
Ethics approval was obtained before recruitment of the first participants
Study design
Randomised, double-blind, parallel-group, comparative phase III study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Hospital
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
1. Agomelatine: 25 mg/day with potential adjustment to 50 mg, given orally for eight weeks
2. Selective serotonin reuptake inhibitor (SSRI)
Followed by an extension double-blind period for 16 weeks.
Intervention type
Drug
Pharmaceutical study type(s)
Phase
Phase III
Drug/device/biological/vaccine name(s)
Agomelatine, selective serotonin reuptake inhibitor (SSRI)
Primary outcome measure
Hamilton Depression Rating Scale (HAM-D) total score will be assessed from baseline to week 24.
Secondary outcome measures
1. Clinical Global Impressions (CGI) Scale
2. Leeds Sleep Evaluation Questionnaire (LSEQ)
3. Hamilton Rating Scale for Anxiety (HAM-A)
4. Safety
Assessed from baseline to week 24.
Overall study start date
06/10/2005
Overall study end date
14/03/2008
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Aged 18 to 65 years
2. Male or female
3. Out-patients
4. Fulfilling Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition (DSM-IV) criteria for major depressive disorder
Participant type(s)
Patient
Age group
Adult
Lower age limit
18 Years
Sex
Both
Target number of participants
500
Participant exclusion criteria
1. Pregnancy, breastfeeding or possibility of becoming pregnant during the study
2. All types of depression other than major depressive disorder
3. Severe or uncontrolled organic disease
Recruitment start date
06/10/2005
Recruitment end date
14/03/2008
Locations
Countries of recruitment
Argentina, Brazil, England, Italy, Spain, United Kingdom
Study participating centre
Eastern and Costal Headquarters
Kent
CT1 1AZ
United Kingdom
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 on 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) 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 | 01/11/2010 | Yes | No |