Condition category
Mental and Behavioural Disorders
Date applied
24/01/2006
Date assigned
31/03/2006
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

Dr Thierry Bougerol

ORCID ID

Contact details

CHU de Grenoble-Hopital Sud
Psychiatrie de l'Adulte
BP 185
Cedex 09
Grenoble
38042
France

Additional identifiers

EudraCT number

2005-002388-95

ClinicalTrials.gov number

Protocol/serial number

CL3-20098-048

Study information

Scientific title

Efficacy of agomelatine (25 to 50 mg/day) given orally on quality of remission in elderly depressed patients, after a 12-week treatment period.A randomised, double-blind, flexible-dose international multicentre study with parallel groups versus paroxetine (20 to 30 mg/day).Twelve-week treatment plus optional continuation for 12 weeks.

Acronym

Study hypothesis

To show the efficacy of agomelatine in improving the quality of remission in elderly depressed patients.

On 26/11/2012 the anticipated end date of this trial was updated from 30/10/2007 to 30/04/2008.

Ethics approval

First approved by the Ethical Committee of Clinical Investigations, Clinical Hospital of San Carlos (Comite Etico de Investigacion Clinica, Hospital Clinico, San Carlos) on 05/08/2005 in Spain, reference number: 05/165-R

Study design

Randomised double-blind flexible-dose international multicentre study with parallel groups versus SSRI drug

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

Agomelatine versus SSRI drug

Intervention type

Drug

Phase

Not Applicable

Drug names

Agomelatine

Primary outcome measure

Quality of sleep

Secondary outcome measures

1. Other sleep patterns
2. Quality of life
3. Daytime drowsiness
4. Residual symptoms of depression

Overall trial start date

07/10/2005

Overall trial end date

30/04/2008

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Out-patients aged at least 60 years with recurrent major depressive episode according to diagnostic and statistical manual of mental disorders (DSM) IV

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

400

Participant exclusion criteria

1. Patients treated with electroconvulsive therapy (ECT) within the last three months
2. Insight-oriented and structured psychotherapy started within the three months before inclusion
3. Light-therapy started within two weeks before inclusion
4. Current diagnosis of neurological disorders
5. Cognitive dysfunction
6. Severe or uncontrolled organic disease, likely to interfere with the conduct of the study

Recruitment start date

07/10/2005

Recruitment end date

30/04/2008

Locations

Countries of recruitment

Austria, Belgium, Denmark, France, Hungary, Italy, Norway, Poland, Portugal, Spain

Trial participating centre

CHU de Grenoble-Hopital Sud
Grenoble
38042
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/CL3-20098-048_synopsis_report.pdf

Publication list

2013 results in: https://www.ncbi.nlm.nih.gov/pubmed/23023074

Publication citations

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 and publication reference added.