Initiation of agomelatine after antidepressant treatment in outpatients suffering major depressive disorder

ISRCTN	ISRCTN97599615
DOI	https://doi.org/10.1186/ISRCTN97599615
Clinical Trials Information System (CTIS)	2010-019556-44
Protocol serial number	CL3-20098-073
Sponsor	Institut de Recherches Internationales Servier (France)
Funder	Institut de Recherches Internationales Servier (France)

Submission date: 16/07/2010
Registration date: 10/09/2010
Last edited: 21/04/2020

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

Prof Michel Lejoyeux
Scientific

Hôpital Bichat - Claude Bernard
46 rue Henri Huchard
Paris
75018
France

Study information

Primary study design	Interventional
Study design	Randomised double then single-blind controlled parallel group international multicentre safety study
Secondary study design	Randomised controlled trial
Scientific title	Initiation of agomelatine after antidepressant treatment by SSRI or SNRI in outpatients suffering Major Depressive Disorder. A 3-week, randomised, double then single-blind, controlled, parallel groups, international, multicentre safety study with a 5-week open extension period.
Study objectives	To compare three different ways to initiate agomelatine after antidepressant treatment.
Ethics approval(s)	Ethics approval was obtained before recruitment of the first participants
Health condition(s) or problem(s) studied	Major depressive disorder
Intervention	Therapeutic oral doses of agomelatine and therapeutic oral doses of previous antidepressant treatment. Run in period, 3-week randomised period then 5-week extension period.
Intervention type	Drug
Phase	Phase III
Drug / device / biological / vaccine name(s)	Agomelatine
Primary outcome measure(s)	Total number of discontinuation emergent symptoms according to the Discontinuation-Emergent Signs and Symptoms check-list evaluated at week 0, week 1, week 2 and week 3.
Key secondary outcome measure(s)	1. Adverse events (evaluated at all visits) 2. Haematology and biochemistry parameters (at week 0 and week 3 - and week 8 for liver function only) 3. Vital signs (blood pressure and heart rate) 4. Body weight, body mass index (BMI) (ASSE, week 0, week 3 and week 8)
Completion date	31/01/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	300
Total final enrolment	316
Key inclusion criteria	1. Aged between 18 and 65 years 2. Fulfilling Diagnostic and Statistical Manual of Mental Disorders 4th Edition (DSM-IV-TR) criteria for major depressive episode of moderate or severe intensity 3. Diagnosis documented using the brief structured interview Mini International Neuropsychiatric Interview (MINI) 4. Clinical Global Impression scale 5. Requiring a change in antidepressant treatment due to an insufficient treatment efficacy associated or not with poor acceptability
Key exclusion criteria	1. "High suicidality" according to MINI 5.0.0. 2. Marked suicidal intent and/or suicidal risk for the current episode, according to the investigator's opinion 3. Hepatic impairment
Date of first enrolment	01/11/2010
Date of final enrolment	31/01/2012

Locations

Countries of recruitment

Belgium
Brazil
France
Germany
Hungary
Italy
Portugal
Spain

Study participating centre

Hôpital Bichat - Claude Bernard

Paris
75018
France

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?
Basic results				No	No
Basic results			21/04/2020	No	No

Editorial Notes

21/04/2020: The following changes were made to the trial record:
1. Added clinicaltrialsregister.eu link to basic results (scientific).
2. The total final enrollment was added.
18/04/2018: Internal review.
28/03/2018: Publication plan and IPD sharing statement were updated.
25/01/2018: Publication plan and IPD sharing statement added.
19/12/2017: results summary added.