A study to determine the maintenance of efficacy of agomelatine to prevent relapse in out-patients with major depressive disorder. A 8 to 10 weeks open period treatment with agomelatine followed by 24 weeks randomised double-blind period, placebo-controlled, parallel groups and 20 weeks of optional double-blind treatment period.

ISRCTN ISRCTN53193024
DOI https://doi.org/10.1186/ISRCTN53193024
EudraCT/CTIS number 2004-003981-13
Secondary identifying numbers CL3-20098-041
Submission date
06/02/2007
Registration date
16/03/2007
Last edited
28/03/2018
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

Prof Frederic Rouillon
Scientific

Hôpital Albert Chenevier
40 rue de Mesly
Créteil
94000
France

Study information

Study designRandomised double-blind parallel group study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleA study to determine the maintenance of efficacy of agomelatine (25 mg to 50 mg) to prevent relapse in out-patients with Major Depressive Disorder. A 8 to 10 weeks open period treatment with agomelatine (25 mg to 50 mg) followed by 24 weeks randomised double-blind period, placebo-controlled, parallel groups and 20 weeks of optional double-blind treatment period.
Study objectivesTo assess the efficacy of agomelatine in the prevention of depressive relapse, in ambulatory patients suffering from major depressive disorder
Ethics approval(s)Sub-Committee on Medical Research Ethics (TUJIKA) of the National Advisory Board on Health Care Ethics, Finland, 01/11/2004
Health condition(s) or problem(s) studiedMajor depressive disorder
InterventionA 8- to 10-week open treatment period with agomelatine followed by 24-week randomised double-blind period, placebo-controlled, parallel groups and 20 weeks of optional double-blind treatment period
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)Agomelatine
Primary outcome measureEfficacy in the prevention of depressive relapse, measured by Hamilton Depression Rating Scale (HAMD) - questionnaire
Secondary outcome measuresSafety parameters, meausred by Adverse Event reporting
Overall study start date09/02/2005
Completion date30/06/2007

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants500
Key inclusion criteria1. Aged 18 to 65 years
2. Male or female
3. Out-patients
4. Requiring an antidepressant treatment
Key exclusion criteria1. All types of depression other than major depressive disorder
2. Severe or uncontrolled organic disease
3. Pregnant or breastfeeding women
Date of first enrolment09/02/2005
Date of final enrolment30/06/2007

Locations

Countries of recruitment

  • Australia
  • Finland
  • France
  • South Africa
  • United Kingdom

Study participating centre

Hôpital Albert Chenevier - 40 rue de Mesly
Créteil
94000
France

Sponsor information

Institut de Recherches Internationales Servier (France)
Industry

50 rue Carnot
Suresnes
92284
France

Website http://www.servier.com/
ROR logo "ROR" https://ror.org/034e7c066

Funders

Funder type

Industry

Institut de Recherches Internationales Servier (France)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planSummary results are published on 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 planThe 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
Results article results 01/08/2009 Yes No
Results article results 01/01/2013 Yes No

Editorial Notes

28/03/2018: Publication plan and IPD sharing statement amended.
25/01/2018: Publication plan and IPD sharing statement added.
18/12/2017: results summary and publication reference added.