Efficacy and safety of three dose regimens of agomelatine versus placebo given once a day for 6 weeks in out-patients suffering from moderate to severe major depressive disorder

ISRCTN	ISRCTN10845256
DOI	https://doi.org/10.1186/ISRCTN10845256
Clinical Trials Information System (CTIS)	2009-011238-84
Protocol serial number	CL3-20098-069
Sponsor	Institut de Recherches Internationales Servier (France)
Funder	Institut de Recherches Internationales Servier (France)

Submission date: 09/04/2010
Registration date: 18/05/2010
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 of protocol

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

Contact information

Dr Ricardo M. Corral
Scientific

Cerviño 4634, 5o B
Buenos Aires
BC1425AHQ
Argentina

Study information

Primary study design	Interventional
Study design	Randomised double-blind placebo-controlled parallel group study followed by a double-blind optional extension period
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
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
Study objectives	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(s)	First Ethics Committee approval obtained on 10/06/2009
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Agomelatine
Primary outcome measure(s)	HAM-D total score, on the week 0 - week 6 period
Key secondary outcome measure(s)	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
Completion date	07/04/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	520
Key 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
Key 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
Date of first enrolment	28/10/2009
Date of final enrolment	07/04/2012

Locations

Countries of recruitment

Argentina
Bulgaria
Finland
Russian Federation
Slovakia
Ukraine

Study participating centre

Cerviño 4634, 5o B

Buenos Aires
BC1425AHQ
Argentina

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
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.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/02/2016		Yes	No
Basic results				No	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

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