Condition category
Mental and Behavioural Disorders
Date applied
07/04/2009
Date assigned
08/05/2009
Last edited
08/11/2013
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

Mrs Christine Marey

ORCID ID

Contact details

50
Rue Carnot
Suresnes
92284
France

Additional identifiers

EudraCT number

2008-004642-92

ClinicalTrials.gov number

Protocol/serial number

CL3-20098-062

Study information

Scientific title

Acronym

Study hypothesis

Long-term antidepressant efficacy of agomelatine compared to serotonin-norepinephrine reuptake inhibitor (SNRI) over a 6-month period.

Ethics approval

Ethics approval was obtained before recruitment of the first participants

Study design

Randomised double-blind parallel-group international multicentre active-controlled 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

Agomelatine 25 or 50 mg versus SNRI over a 6-month period.

Intervention type

Drug

Phase

Phase III

Drug names

Agomelatine

Primary outcome measures

Hamilton Rating Scale for Depression (HAM-D) total score, from baseline to week 24.

Secondary outcome measures

1. HAM-D items, from baseline to week 24
2. Clinical Global Impression scale, from baseline to week 24
3. Pittsburgh Sleep Quality Index, from baseline to week 24
4. Leeds Sleep Evaluation Questionnaire, from week 1 to week W2
5. Sheehan Disability Scale, from baseline to week 24
6. Safety from baseline to week 24

Overall trial start date

29/04/2009

Overall trial end date

31/10/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged between 18 and 65 years, either sex
2. Out-patients fulfilling Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) criteria for major depressive disorder

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

400

Participant exclusion criteria

Women of childbearing potential without effective contraception

Recruitment start date

29/04/2009

Recruitment end date

31/10/2010

Locations

Countries of recruitment

Australia, Brazil, Canada, Greece, Hungary, Italy, Portugal, South Africa, Spain, United Kingdom

Trial participating centre

50, Rue Carnot
Suresnes
92284
France

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

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes