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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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4 May 2020 |
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Main ID: |
ISRCTN96725312 |
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Date of registration:
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08/05/2009 |
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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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Evaluation of efficacy and clinical benefit of agomelatine in patients with major depressive disorder compared to serotonin-norepinephrine reuptake inhibitor (SNRI)
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Scientific title:
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Evaluation of efficacy and clinical benefit of agomelatine (25 to 50 mg/day) over a 6-month treatment period in patients with Major Depressive Disorder.A randomised, double-blind, international multicentre study with parallel groups versus duloxetine (60 mg/day).Twenty-four weeks of treatment.
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Date of first enrolment:
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29/04/2009 |
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Target sample size:
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400 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN96725312 |
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Study type:
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Interventional |
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Study design:
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Randomised double-blind parallel-group international multicentre active-controlled phase III study (Treatment)
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Phase:
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Phase III
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Countries of recruitment
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Australia
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Brazil
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Canada
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Greece
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Hungary
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Italy
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Portugal
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South Africa
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Spain
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United Kingdom
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Contacts
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Christine
Marey |
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Address:
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50 rue Carnot
92284
Suresnes
France |
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Telephone:
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria:
1. Aged between 18 and 65 years, either sex
2. Out-patients fulfilling Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) criteria for major depressive disorder
Exclusion criteria: Women of childbearing potential without effective contraception
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 SNRI over a 6-month period.
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Primary Outcome(s)
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Hamilton Rating Scale for Depression (HAM-D) total score, from baseline to week 24.
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Secondary Outcome(s)
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1. HAM-D items, from baseline to week 24
2. Clinical Global Impression scale, from baseline to week 24
3. Pittsburgh Sleep Quality Index, from baseline to week 24
4. Leeds Sleep Evaluation Questionnaire, from week 1 to week W2
5. Sheehan Disability Scale, from baseline to week 24
6. Safety from baseline to week 24
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Secondary ID(s)
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CL3-20098-062
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2008-004642-92
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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:
Ethics approval was obtained before recruitment of the first participants
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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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31/10/2010 |
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URL:
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