Condition category
Mental and Behavioural Disorders
Date applied
07/04/2010
Date assigned
30/04/2010
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 Reinhard Heun

ORCID ID

Contact details

Radbourne Unit
Derby City General Hospital
Uttoxeter Road
Derby
DE22 3NE
United Kingdom

Additional identifiers

EudraCT number

2009-011795-29

ClinicalTrials.gov number

Protocol/serial number

CL3-20098-070

Study information

Scientific title

"Efficacy and safety of agomelatine oral administration (25 to 50 mg/day) in elderly patients suffering from Major Depressive Disorder.
A 8-week, randomised, double-blind, flexible-dose, parallel groups, placebo-controlled, international, multicentre study followed by an extension double-blind treatment period of 16 weeks"

Acronym

Study hypothesis

To demonstrate the efficacy of agomelatine compared to placebo using the 17-item Hamilton Rating Scale for Depression (HAM-D-17), after 8 weeks of treatment in elderly out-patients suffering from major depressive disorder.

Ethics approval

First Ethics Committee approval obtained on 18/08/2009 in Finland

Study design

Randomised double-blind flexible-dose parallel group placebo-controlled international multicentre study, followed by an extension double-blind treatment period

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 25 or 50 mg versus placebo. 8-week treatment followed by an extension double-blind treatment period of 16 weeks.

Intervention type

Drug

Phase

Phase III

Drug names

Agomelatine

Primary outcome measure

HAM-D total score, on the week 0 - 8 period

Secondary outcome measures

1. Clinical Global Impression scale scores, from baseline to week 8 and 24
2. Sheehan Disability Scale scores, from baseline to week 8 and 24
3. Safety from baseline to week 8 and 24

Overall trial start date

04/11/2009

Overall trial end date

31/10/2011

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Out-patients of both genders aged more than 65 years
2. Fulfilling Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) criteria for a moderate to severe episode of a recurrent major depressive disorder

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

210

Participant exclusion criteria

1. All types of depression other than major depressive disorder recurrent
2. Severe or uncontrolled organic diseases, likely to interfere with the conduct of the study
3. Current diagnosis of neurological disorders

Recruitment start date

04/11/2009

Recruitment end date

31/10/2011

Locations

Countries of recruitment

Argentina, Finland, Mexico, Portugal, Romania

Trial participating centre

Radbourne Unit
Derby
DE22 3NE
United Kingdom

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/CL3-20098-070_synopsis_report.pdf

Publication list

1. 2013 results in: https://www.ncbi.nlm.nih.gov/pubmed/23842010
2. 2017 results in: https://www.ncbi.nlm.nih.gov/pubmed/28383308

Publication citations

  1. Results

    Heun R, Ahokas A, Boyer P, Giménez-Montesinos N, Pontes-Soares F, Olivier V, , The efficacy of agomelatine in elderly patients with recurrent major depressive disorder: a placebo-controlled study., J Clin Psychiatry, 2013, 74, 6, 587-594, doi: 10.4088/JCP.12m08250.

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. 19/12/2017: results summary and publication reference added