Condition category
Mental and Behavioural Disorders
Date applied
03/04/2007
Date assigned
22/06/2007
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

Dr Maria-Antonia Quera-Salva

ORCID ID

Contact details

Hôpital Raymond Poincaré
104
boulevard Raymond Poincaré
Garches
92380
France

Additional identifiers

EudraCT number

2006-004716-48

ClinicalTrials.gov number

Protocol/serial number

CL3-20098-056

Study information

Scientific title

Acronym

Study hypothesis

To demonstrate that depressed patients treated with agomelatine present a greater improvement in sleep efficiency than patients treated with Selective Serotonin Reuptake Inhibitors (SSRI).

Ethics approval

First approval received from the local ethics committee (Comité de Protection des Personnes Ile de France VIII) on the 18/01/2007 (ref: 070101)

Study design

Six-week randomised double-blind parallel groups study with agomelatine versus SSRI, followed by a double-blind optional treatment extension period up to six months with agomelatine versus SSRI

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 doses of agomelatine versus therapeutic doses of SSRI.

Intervention type

Drug

Phase

Not Applicable

Drug names

Agomelatine, SSRI

Primary outcome measures

Effects of agomelatine on sleep Electroencephalogram (EEG) parameters, corresponding to sleep efficiency index, compared to SSRI in patients with major depressive disorder.

Secondary outcome measures

1. Other sleep parameters
2. Subjective sleep parameters
3. Daytime performance
4. Evaluation of depression with the Hamilton rating scale for Depression (HAM-D) scale
5. Safety measured with adverse events, laboratory parameters, and Electrocardiogram (ECG) parameters

Overall trial start date

15/02/2007

Overall trial end date

30/09/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged between 18 and 60 years
2. Male or female
3. Fulfilling Diagnostic and Statistical Manual of mental disorders fourth edition (DSM-IV-TR) criteria for major depressive disorder

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

130

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

Recruitment start date

15/02/2007

Recruitment end date

30/09/2008

Locations

Countries of recruitment

Australia, Austria, Brazil, Finland, France, Germany, Spain, Taiwan, United Kingdom

Trial participating centre

Hôpital Raymond Poincaré
Garches
92380
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