Efficacy of agomelatine given orally on improvement of subjective sleep in patients with major depressive disorder: a randomised, double-blind, flexible-dose international multicentre study with parallel groups versus Selective Serotonin Reuptake Inhibitor (SSRI) twelve week treatment plus double-blind extension for 12 weeks

ISRCTN ISRCTN55250367
DOI https://doi.org/10.1186/ISRCTN55250367
EudraCT/CTIS number 2006-006540-54
Secondary identifying numbers CL3-20098-063
Submission date
15/05/2007
Registration date
12/07/2007
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 Emmanuelle Corruble
Scientific

CHU de Bicêtre
78 rue du Général Leclerc
Le Kremlin Bicetre
94275
France

Study information

Study designRandomised double-blind parallel-group flexible-dose international multicentre comparative phase III 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 titleEfficacy of agomelatine (25 to 50 mg/day) given orally on improvement of subjective sleep in patients with Major Depressive Disorder. A randomised, double-blind, flexible-dose international multicentre study with parallel groups versus escitalopram (10 to 20mg/day). Twelve-week treatment plus double-blind extension for 12 weeks.
Study objectivesTo study the effect of agomelatine on subjective sleep versus Selective Serotonin Reuptake Inhibitor (SSRI).
Ethics approval(s)First ethics committee approval in Brazil on 01/03/2007 from Comitê de Etica em Pesquisa do Instituto de Providencia dos Servidores do Estado de Minas Gerais - IPSEMG/ Hospital Governador Israël Pinheiro HGIP ; registration number: 245/07 ; in Belo Horizonte
Health condition(s) or problem(s) studiedMajor Depressive Disorder
InterventionTherapeutic oral doses of agomelatine versus therapeutic oral doses of SSRI - twelve week treatment plus double-blind extension for twelve weeks.
Intervention typeDrug
Pharmaceutical study type(s)
PhasePhase III
Drug / device / biological / vaccine name(s)Agomelatine, Selective Serotonin Reuptake Inhibitor (SSRI)
Primary outcome measureImprovement of subjective sleep, measured by sleep score compared to SSRI
Secondary outcome measures1. Evaluation of depression (Hamilton Depression [HAM-D] scale)
2. Evaluation of daytime drowsiness
Overall study start date22/05/2007
Completion date15/04/2009

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants300
Total final enrolment324
Key inclusion criteria1. Aged between 18 to 70 years (included)
2. Male or female
3. Fulfilling Diagnostic and Statistical Manual of mental disorders fourth edition (DSM-IV) criteria for major depressive disorder
Key exclusion criteria1. Women of childbearing potential without effective contraception as well as pregnant or breastfeeding women
2. All types of depression other than major depressive disorder, all other psychiatric disorders
Date of first enrolment22/05/2007
Date of final enrolment15/04/2009

Locations

Countries of recruitment

  • Australia
  • Brazil
  • Canada
  • France
  • Russian Federation
  • South Africa
  • United Kingdom

Study participating centre

CHU de Bicêtre - 78
Le Kremlin Bicentre
94275
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
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 updated.
25/01/2018: Publication plan and IPD sharing statement added.
18/12/2017: results summary added.`