Condition category
Mental and Behavioural Disorders
Date applied
15/05/2007
Date assigned
12/07/2007
Last edited
14/07/2014
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 Emmanuelle Corruble

ORCID ID

Contact details

CHU de Bicêtre - 78
Rue du Général Leclerc
Le Kremlin Bicentre
94275
France

Additional identifiers

EudraCT number

2006-006540-54

ClinicalTrials.gov number

Protocol/serial number

CL3-20098-063

Study information

Scientific title

Acronym

Study hypothesis

To study the effect of agomelatine on subjective sleep versus Selective Serotonin Reuptake Inhibitor (SSRI).

Ethics approval

First ethics committee approval in Brazil on 01/03/2007 from Comitê de Etica em Pesquisa do Instituto de Providencia dos Servidores do Estado de Minas Gerais - IPSEMG/ Hospital Governador Israël Pinheiro HGIP ; registration number: 245/07 ; in Belo Horizonte

Study design

Randomised double-blind parallel-group flexible-dose international multicentre comparative phase III 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

Therapeutic oral doses of agomelatine versus therapeutic oral doses of SSRI - twelve week treatment plus double-blind extension for twelve weeks.

Intervention type

Drug

Phase

Phase III

Drug names

Agomelatine, Selective Serotonin Reuptake Inhibitor (SSRI)

Primary outcome measures

Improvement of subjective sleep, measured by sleep score compared to SSRI

Secondary outcome measures

1. Evaluation of depression (Hamilton Depression [HAM-D] scale)
2. Evaluation of daytime drowsiness

Overall trial start date

22/05/2007

Overall trial end date

15/04/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged between 18 to 70 years (included)
2. Male or female
3. 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

300

Participant exclusion criteria

1. Women of childbearing potential without effective contraception as well as pregnant or breastfeeding women
2. All types of depression other than major depressive disorder, all other psychiatric disorders

Recruitment start date

22/05/2007

Recruitment end date

15/04/2009

Locations

Countries of recruitment

Australia, Brazil, Canada, France, Russian Federation, South Africa, United Kingdom

Trial participating centre

CHU de Bicêtre - 78
Le Kremlin Bicentre
94275
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