Submission date
03/04/2007
Registration date
22/06/2007
Last edited
18/04/2018
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English Summary

Not provided at time of registration and not expected to be available in the future

Study website

Contact information

Type

Scientific

Contact name

Dr Maria-Antonia Quera-Salva

ORCID ID

Contact details

Hôpital Raymond Poincaré
104 boulevard Raymond Poincaré
Garches
92380
France

Additional identifiers

EudraCT/CTIS number

2006-004716-48

IRAS number

ClinicalTrials.gov number

Secondary identifying numbers

CL3-20098-056

Study information

Scientific title

"Effects of agomelatine (25 to 50 mg/day) on sleep EEG parameters compared to escitalopram in patients with Major Depressive Disorder.
A 6-week randomised, double-blind parallel groups study versus comparator, followed by a double-blind optional treatment extension period up to 6 months."

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(s)

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

Study setting(s)

Not specified

Study 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

Pharmaceutical study type(s)

Phase

Not Applicable

Drug/device/biological/vaccine name(s)

Agomelatine, SSRI

Primary outcome measure

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 study start date

15/02/2007

Overall study end date

30/09/2008

Reason abandoned (if study stopped)

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(s)

Patient

Age group

Adult

Lower age limit

18 Years

Sex

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

Study 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/

ROR

https://ror.org/034e7c066

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.

Intention to publish date

Individual participant data (IPD) Intention to share

Yes

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.

IPD sharing plan summary

Available on request

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Basic results No No
Results article results 01/09/2011 Yes No

Additional files

Editorial Notes

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