Efficacy and safety of agomelatine (25 mg/day with potential adjustment to 50 mg) given orally for eight weeks in out-patients with severe major depressive disorder: a randomised double-blind, parallel groups, international study versus selective serotonin reuptake inhibitor (SSRI) with a double-blind extension period of 16 weeks

ISRCTN ISRCTN19313268
DOI https://doi.org/10.1186/ISRCTN19313268
EudraCT/CTIS number 2004-004008-19
Secondary identifying numbers CL3-20098-045
Submission date
29/07/2008
Registration date
19/08/2008
Last edited
28/03/2018
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration and not expected to be available in the future

Contact information

Prof Anthony Hale
Scientific

Eastern and Costal Headquarters
St Martin's Hospital
Littlebourne Road
Canterbury
Kent
CT1 1AZ
United Kingdom

Study information

Study designRandomised, double-blind, parallel-group, comparative phase III study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleEfficacy 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.
Study objectivesTo 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
Health condition(s) or problem(s) studiedMajor depressive disorder
Intervention1. 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 typeDrug
Pharmaceutical study type(s)
PhasePhase III
Drug / device / biological / vaccine name(s)Agomelatine, selective serotonin reuptake inhibitor (SSRI)
Primary outcome measureHamilton Depression Rating Scale (HAM-D) total score will be assessed from baseline to week 24.
Secondary outcome measures1. 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 date06/10/2005
Completion date14/03/2008

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants500
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment06/10/2005
Date of final enrolment14/03/2008

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

Institut de Recherches Internationales Servier (France)
Industry

50 rue Carnot
Suresnes
92284
France

Website http://www.servier.com/
ROR logo "ROR" https://ror.org/034e7c066

Funders

Funder type

Industry

Institut de Recherches Internationales Servier (France)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planSummary 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.
IPD sharing planThe 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.

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

Editorial Notes

28/03/2018: Publication plan and IPD sharing statement amended.
25/01/2018: Publication plan and IPD sharing statement added.
18/12/2017: results summary and publication reference added.