Condition category
Mental and Behavioural Disorders
Date applied
29/07/2008
Date assigned
19/08/2008
Last edited
28/03/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Prof Anthony Hale

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

2004-004008-19

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

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

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

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

Phase

Phase III

Drug names

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 trial start date

06/10/2005

Overall trial 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

Patient

Age group

Adult

Gender

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, Italy, Spain, United Kingdom

Trial 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

http://www.servier.com/

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.
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/CL3-20098-045_synopsis_report.pdf

Publication list

2010 results in https://www.ncbi.nlm.nih.gov/pubmed/?term=20856123

Publication citations

Additional files

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.