Condition category
Mental and Behavioural Disorders
Date applied
09/04/2010
Date assigned
18/05/2010
Last edited
05/11/2013
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 Ricardo M. Corral

ORCID ID

Contact details

Cerviño 4634
5o B
Buenos Aires
BC1425AHQ
Argentina

Additional identifiers

EudraCT number

2009-011238-84

ClinicalTrials.gov number

Protocol/serial number

CL3-20098-069

Study information

Scientific title

Efficacy and safety of three dose regimens of agomelatine (10, 25, 25 - 50 mg) versus placebo given once a day for 6 weeks in out-patients suffering from moderate to severe major depressive disorder: a 6-week randomised, double-blind, placebo-controlled, parallel groups study followed by a double-blind optional 18-week extension period

Acronym

Study hypothesis

To demonstrate the short term efficacy of at least one of the three dose regimens of agomelatine (versus placebo) using the 17-item Hamilton Rating Scale for Depression (HAM-D-17).

Ethics approval

First Ethics Committee approval obtained on 10/06/2009

Study design

Randomised double-blind placebo-controlled parallel group study followed by a double-blind optional extension period

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

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 10, 25 or 50 mg versus placebo for 6 weeks followed by an optional 18-week extension period.

Intervention type

Drug

Phase

Phase III

Drug names

Agomelatine

Primary outcome measures

HAM-D total score, on the week 0 - week 6 period

Secondary outcome measures

1. HAM-D items, from baseline to week 24
2. Clinical Global Impression scale, from baseline to week 6 and 24
3. Sheehan Disability Scale, from baseline to week 6 and 24
4. Hospital Anxiety and Depression Scale, from baseline to week 6
5. Safety from baseline to week 6 and 24

Overall trial start date

28/10/2009

Overall trial end date

07/04/2012

Reason abandoned

Eligibility

Participant inclusion criteria

1. Out-patients of both genders aged between 18 (or legal age) and 65 years of age
2. Fulfilling Diagnostic and Statistical Manual, Fourth Edition, Text Revision (DSM-IV-TR) criteria for major depressive disorder (MDD) of moderate or severe intensity

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

520

Participant exclusion criteria

1. Women of childbearing potential without effective contraception
2. Other types of depression than MDD
3. Severe or uncontrolled organic diseases, likely to interfere with the conduct of the study

Recruitment start date

28/10/2009

Recruitment end date

07/04/2012

Locations

Countries of recruitment

Argentina, Bulgaria, Finland, Russian Federation, Slovakia, Ukraine

Trial participating centre

Cerviño 4634, 5o B
Buenos Aires
BC1425AHQ
Argentina

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