Efficacy of agomelatine given orally on rest/activity circadian rhythms in outpatients with major depressive disorder: a randomised, double-blind international study with parallel groups versus Selective Serotonin Reuptake Inhibitor (SSRI). Six-week treatment plus optional continuation for 18 weeks.

ISRCTN ISRCTN49376288
DOI https://doi.org/10.1186/ISRCTN49376288
EudraCT/CTIS number 2004-004009-10
Secondary identifying numbers CL3-20098-046
Submission date
04/05/2007
Registration date
08/06/2007
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

Prof Franck Bayle
Scientific

Centre Hospitalier Sainte-Anne
1 rue Cabanis
Paris cedex 14
75674
France

Study information

Study designRandomised double-blind parallel-group comparative phase III study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleEfficacy of agomelatine (25 mg/day with potential adjustment to 50 mg) given orally on rest/activity circadian rhythms in outpatients with Major Depressive Disorder. A randomized, double-blind international study with parallel groups versus sertraline (50 mg/day with potential adjustment to 100 mg). Six-week treatment plus optional continuation for 18 weeks.
Study objectivesTo demonstrate that agomelatine improves rest/activity circadian rhythms faster than Selective Serotonin Reuptake Inhibitor (SSRI) in outpatients suffering from major depressive disorder.
Ethics approval(s)First ethics committee approval in France received from the local ethics board (Comités de Consultation pour la Protection des Personnes se prêtant à la Recherche Biomédicale [CCPPRB] Paris-Broussais) on the 15/03/2005 (ref: 2005-006)
Health condition(s) or problem(s) studiedMajor depressive disorder
InterventionAgomelatine versus SSRI
Intervention typeDrug
Pharmaceutical study type(s)
PhasePhase III
Drug / device / biological / vaccine name(s)Agomelatine, Selective Serotonin Reuptake Inhibitor (SSRI)
Primary outcome measureEfficacy assessed by actimetry recording
Secondary outcome measures1. Depression
2. Sleep
Overall study start date01/04/2005
Completion date30/09/2007

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
Upper age limit60 Years
SexBoth
Target number of participants300
Key inclusion criteria1. Male or female
2. Out-patients
3. Aged of 18 to 60 years (inclusive)
4. Fulfilling Diagnostic and Statistical Manual of Mental Disorders - fourth edition (DSM-IV) criteria for major depressive disorder
5. Requiring an antidepressant treatment
Key exclusion criteria1. Pregnant or breastfeeding, women of childbearing potential without effective contraception
2. All types of depression other than major depressive disorder
3. Severe or uncontrolled disease
Date of first enrolment01/04/2005
Date of final enrolment30/09/2007

Locations

Countries of recruitment

  • Austria
  • France
  • Germany
  • Italy
  • Poland
  • Spain

Study participating centre

Centre Hospitalier Sainte-Anne
Paris cedex 14
75674
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 in 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 01/02/2010 Yes No

Editorial Notes

18/04/2018: Internal review.
28/03/2018: Publication and dissemination plan and IPD sharing statement updated.
25/01/2018: Publication plan and IPD sharing statement added.
18/12/2017: results summary added.