Condition category
Mental and Behavioural Disorders
Date applied
06/02/2007
Date assigned
16/03/2007
Last edited
13/08/2014
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 Frederic Rouillon

ORCID ID

Contact details

Hôpital Albert Chenevier - 40 rue de Mesly
Créteil
94000
France

Additional identifiers

EudraCT number

2004-003981-13

ClinicalTrials.gov number

Protocol/serial number

CL3-20098-041

Study information

Scientific title

Acronym

Study hypothesis

To assess the efficacy of agomelatine in the prevention of depressive relapse, in ambulatory patients suffering from major depressive disorder

Ethics approval

Sub-Committee on Medical Research Ethics (TUJIKA) of the National Advisory Board on Health Care Ethics, Finland, 01/11/2004

Study design

Randomised double-blind parallel group study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

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

A 8- to 10-week open treatment period with agomelatine followed by 24-week randomised double-blind period, placebo-controlled, parallel groups and 20 weeks of optional double-blind treatment period

Intervention type

Drug

Phase

Not Applicable

Drug names

Agomelatine

Primary outcome measures

Efficacy in the prevention of depressive relapse, measured by Hamilton Depression Rating Scale (HAMD) - questionnaire

Secondary outcome measures

Safety parameters, meausred by Adverse Event reporting

Overall trial start date

09/02/2005

Overall trial end date

30/06/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged 18 to 65 years
2. Male or female
3. Out-patients
4. Requiring an antidepressant treatment

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

500

Participant exclusion criteria

1. All types of depression other than major depressive disorder
2. Severe or uncontrolled organic disease
3. Pregnant or breastfeeding women

Recruitment start date

09/02/2005

Recruitment end date

30/06/2007

Locations

Countries of recruitment

Australia, Finland, France, South Africa, United Kingdom

Trial participating centre

Hôpital Albert Chenevier - 40 rue de Mesly
Créteil
94000
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

2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23151774

Publication citations

  1. Results

    Goodwin GM, Boyer P, Emsley R, Rouillon F, de Bodinat C, Is it time to shift to better characterization of patients in trials assessing novel antidepressants? An example of two relapse prevention studies with agomelatine., Int Clin Psychopharmacol, 2013, 28, 1, 20-28, doi: 10.1097/YIC.0b013e32835b0814.

Additional files

Editorial Notes