Condition category
Mental and Behavioural Disorders
Date applied
16/07/2010
Date assigned
10/09/2010
Last edited
05/11/2013
Prospective/Retrospective
Prospectively 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 Michel Lejoyeux

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

2010-019556-44

ClinicalTrials.gov number

Protocol/serial number

CL3-20098-073

Study information

Scientific title

Acronym

Study hypothesis

To compare three different ways to initiate agomelatine after antidepressant treatment.

Ethics approval

Ethics approval was obtained before recruitment of the first participants

Study design

Randomised double then single-blind controlled parallel group international multicentre safety study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

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 names

Agomelatine

Primary outcome measures

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.

Secondary outcome measures

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)

Overall trial start date

01/11/2010

Overall trial end date

31/01/2012

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

300

Participant 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

Recruitment start date

01/11/2010

Recruitment end date

31/01/2012

Locations

Countries of recruitment

Belgium, Brazil, France, Germany, Hungary, Italy, Portugal, Spain

Trial participating centre

Hôpital Bichat - Claude Bernard
Paris
75018
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

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