Condition category
Mental and Behavioural Disorders
Date applied
04/05/2007
Date assigned
08/06/2007
Last edited
18/04/2018
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 Franck Bayle

ORCID ID

Contact details

Centre Hospitalier Sainte-Anne
1 rue Cabanis
Paris cedex 14
75674
France

Additional identifiers

EudraCT number

2004-004009-10

ClinicalTrials.gov number

Protocol/serial number

CL3-20098-046

Study information

Scientific title

Efficacy of agomelatine (25 mg/day with potential adjustment to 50 mg) given orally on rest/activity circadian rhythms in outpatients with Major Depressive Disorder. A randomized, double-blind international study with parallel groups versus sertraline (50 mg/day with potential adjustment to 100 mg). Six-week treatment plus optional continuation for 18 weeks.

Acronym

Study hypothesis

To demonstrate that agomelatine improves rest/activity circadian rhythms faster than Selective Serotonin Reuptake Inhibitor (SSRI) in outpatients suffering from major depressive disorder.

Ethics approval

First ethics committee approval in France received from the local ethics board (Comités de Consultation pour la Protection des Personnes se prêtant à la Recherche Biomédicale [CCPPRB] Paris-Broussais) on the 15/03/2005 (ref: 2005-006)

Study design

Randomised double-blind parallel-group comparative phase III study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

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 versus SSRI

Intervention type

Drug

Phase

Phase III

Drug names

Agomelatine, Selective Serotonin Reuptake Inhibitor (SSRI)

Primary outcome measure

Efficacy assessed by actimetry recording

Secondary outcome measures

1. Depression
2. Sleep

Overall trial start date

01/04/2005

Overall trial end date

30/09/2007

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Male or female
2. Out-patients
3. Aged of 18 to 60 years (inclusive)
4. Fulfilling Diagnostic and Statistical Manual of Mental Disorders - fourth edition (DSM-IV) criteria for major depressive disorder
5. Requiring an antidepressant treatment

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

300

Participant exclusion criteria

1. Pregnant or breastfeeding, women of childbearing potential without effective contraception
2. All types of depression other than major depressive disorder
3. Severe or uncontrolled disease

Recruitment start date

01/04/2005

Recruitment end date

30/09/2007

Locations

Countries of recruitment

Austria, France, Germany, Italy, Poland, Spain

Trial participating centre

Centre Hospitalier Sainte-Anne
Paris cedex 14
75674
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

Summary results are published in 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/CL3-20098-046_synopsis_report.pdf

Publication list

2010 results in: http://www.ncbi.nlm.nih.gov/pubmed/20193645

Publication citations

  1. Results

    Kasper S, Hajak G, Wulff K, Hoogendijk WJ, Montejo AL, Smeraldi E, Rybakowski JK, Quera-Salva MA, Wirz-Justice AM, Picarel-Blanchot F, Baylé FJ, Efficacy of the novel antidepressant agomelatine on the circadian rest-activity cycle and depressive and anxiety symptoms in patients with major depressive disorder: a randomized, double-blind comparison with sertraline., J Clin Psychiatry, 2010, 71, 2, 109-120, doi: 10.4088/JCP.09m05347blu.

Additional files

Editorial Notes

18/04/2018: Internal review. 28/03/2018: Publication and dissemination plan and IPD sharing statement updated. 25/01/2018: Publication plan and IPD sharing statement added. 18/12/2017: results summary added.