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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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21 May 2018 |
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Main ID: |
ISRCTN57507360 |
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Date of registration:
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30/04/2010 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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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
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Scientific title:
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"Efficacy and safety of agomelatine oral administration (25 to 50 mg/day) in elderly patients suffering from Major Depressive Disorder.
A 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" |
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Date of first enrolment:
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04/11/2009 |
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Target sample size:
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210 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN57507360 |
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Study type:
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Interventional |
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Study design:
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Randomised double-blind flexible-dose parallel group placebo-controlled international multicentre study, followed by an extension double-blind treatment period (Treatment)
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Phase:
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Phase III
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Countries of recruitment
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Argentina
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Finland
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Mexico
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Portugal
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Romania
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Contacts
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Name:
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Reinhard
Heun |
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Address:
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Radbourne Unit
Derby City General Hospital
Uttoxeter Road
DE22 3NE
Derby
United Kingdom |
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Email:
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Affiliation:
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Name:
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Affiliation:
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Key inclusion & exclusion criteria
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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
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
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Major depressive disorder
Mental and Behavioural Disorders
Depressive episode
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Intervention(s)
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Agomelatine 25 or 50 mg versus placebo. 8-week treatment followed by an extension double-blind treatment period of 16 weeks.
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Primary Outcome(s)
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HAM-D total score, on the week 0 - 8 period
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Secondary Outcome(s)
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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
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Secondary ID(s)
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2009-011795-29
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CL3-20098-070
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Source(s) of Monetary Support
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Institut de Recherches Internationales Servier (France)
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Ethics review
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Status:
Approval date:
Contact:
First Ethics Committee approval obtained on 18/08/2009 in Finland
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Results
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Results available:
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Yes |
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Date Posted:
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Date Completed:
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31/10/2011 |
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URL:
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