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Efficacy and safety of agomelatine oral administration (25 to 50 mg/day) in elderly patients suffering from major depressive disorder: an 8-week, randomised, double-blind, flexible-dose, parallel groups, placebo-controlled, international, multicentre study followed by an extension double-blind treatment period of 16 weeks
ISRCTN ISRCTN57507360
DOI 10.1186/ISRCTN57507360
ClinicalTrials.gov identifier
EudraCT number 2009-011795-29
Public title Efficacy and safety of agomelatine oral administration (25 to 50 mg/day) in elderly patients suffering from major depressive disorder: an 8-week, randomised, double-blind, flexible-dose, parallel groups, placebo-controlled, international, multicentre study followed by an extension double-blind treatment period of 16 weeks
Scientific title
Acronym N/A
Serial number at source CL3-20098-070
Study hypothesis To demonstrate the efficacy of agomelatine compared to placebo using the 17-item Hamilton Rating Scale for Depression (HAM-D-17), after 8 weeks of treatment in elderly out-patients suffering from major depressive disorder.
Lay summary Not provided at time of registration and not expected to be available in the future
Ethics approval First Ethics Committee approval obtained on 18/08/2009 in Finland
Study design Randomised double-blind flexible-dose parallel group placebo-controlled international multicentre study, followed by an extension double-blind treatment period
Countries of recruitment Argentina, Finland, Mexico, Portugal, Romania
Disease/condition/study domain Major depressive disorder
Participants - inclusion criteria 1. Out-patients of both genders aged more than 65 years
2. Fulfilling Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) criteria for a moderate to severe episode of a recurrent major depressive disorder
Participants - exclusion criteria 1. All types of depression other than major depressive disorder recurrent
2. Severe or uncontrolled organic diseases, likely to interfere with the conduct of the study
3. Current diagnosis of neurological disorders
Anticipated start date 04/11/2009
Anticipated end date 31/10/2011
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 210
Interventions Agomelatine 25 or 50 mg versus placebo. 8-week treatment followed by an extension double-blind treatment period of 16 weeks.
Primary outcome measure(s) HAM-D total score, on the week 0 - 8 period
Secondary outcome measure(s) 1. Clinical Global Impression scale scores, from baseline to week 8 and 24
2. Sheehan Disability Scale scores, from baseline to week 8 and 24
3. Safety from baseline to week 8 and 24
Sources of funding Institut de Recherches Internationales Servier (France)
Trial website
Publications 2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23842010
Contact name Prof  Reinhard  Heun
  Address Radbourne Unit
Derby City General Hospital
Uttoxeter Road
  City/town Derby
  Zip/Postcode DE22 3NE
  Country United Kingdom
Sponsor Institut de Recherches Internationales Servier (France)
  Address 50 rue Carnot
  City/town Suresnes
  Zip/Postcode 92284
  Country France
  Sponsor website: http://www.servier.com/
Date applied 07/04/2010
Last edited 05/11/2013
Date ISRCTN assigned 30/04/2010
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