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.

• Register: ISRCTN
• Last refreshed on: 21 May 2018
• Main ID: ISRCTN49376288
• Date of registration: 08/06/2007
• Prospective Registration: No
• Primary sponsor: Institut de Recherches Internationales Servier (France)
• Public title: 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.
• Scientific title: Efficacy 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.
• Date of first enrolment: 01/04/2005
• Target sample size: 300
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN49376288
• Study type: Interventional
• Study design: Randomised double-blind parallel-group comparative phase III study (Treatment)
• Phase: Phase III

Countries of recruitment

Austria, France, Germany, Italy, Poland, Spain

Contacts

• Name: Franck Bayle

Key inclusion & exclusion criteria

Inclusion criteria: 1. 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
Exclusion criteria: 1. 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

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Major depressive disorder
Mental and Behavioural Disorders
Depression

Intervention(s)

Agomelatine versus SSRI

Primary Outcome(s)

Efficacy assessed by actimetry recording

Secondary Outcome(s)

1. Depression
2. Sleep

Secondary ID(s)

2004-004009-10

CL3-20098-046

Source(s) of Monetary Support

Institut de Recherches Internationales Servier (France)

Ethics review

Status:
Approval date:
Contact:

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)

Results

• Results available: Yes
• Date Completed: 30/09/2007