A study to determine the maintenance of efficacy of agomelatine to prevent relapse in out-patients with major depressive disorder. A 8 to 10 weeks open period treatment with agomelatine followed by 24 weeks randomised double-blind period, placebo-controlled, parallel groups and 20 weeks of optional double-blind treatment period.

• Register: ISRCTN
• Last refreshed on: 30 April 2018
• Main ID: ISRCTN53193024
• Date of registration: 16/03/2007
• Prospective Registration: No
• Primary sponsor: Institut de Recherches Internationales Servier (France)
• Public title: A study to determine the maintenance of efficacy of agomelatine to prevent relapse in out-patients with major depressive disorder. A 8 to 10 weeks open period treatment with agomelatine followed by 24 weeks randomised double-blind period, placebo-controlled, parallel groups and 20 weeks of optional double-blind treatment period.
• Scientific title: A study to determine the maintenance of efficacy of agomelatine (25 mg to 50 mg) to prevent relapse in out-patients with Major Depressive Disorder. A 8 to 10 weeks open period treatment with agomelatine (25 mg to 50 mg) followed by 24 weeks randomised double-blind period, placebo-controlled, parallel groups and 20 weeks of optional double-blind treatment period.
• Date of first enrolment: 09/02/2005
• Target sample size: 500
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN53193024
• Study type: Interventional
• Study design: Randomised double-blind parallel group study (Treatment)
• Phase: Not Applicable

Countries of recruitment

Australia, Finland, France, South Africa, United Kingdom

Contacts

• Name: Frederic Rouillon

Key inclusion & exclusion criteria

Inclusion criteria: 1. Aged 18 to 65 years
2. Male or female
3. Out-patients
4. Requiring an antidepressant treatment
Exclusion criteria: 1. All types of depression other than major depressive disorder
2. Severe or uncontrolled organic disease
3. Pregnant or breastfeeding women

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Major depressive disorder
Mental and Behavioural Disorders
Depressive disorder

Intervention(s)

A 8- to 10-week open treatment period with agomelatine followed by 24-week randomised double-blind period, placebo-controlled, parallel groups and 20 weeks of optional double-blind treatment period

Primary Outcome(s)

Efficacy in the prevention of depressive relapse, measured by Hamilton Depression Rating Scale (HAMD) - questionnaire

Secondary Outcome(s)

Safety parameters, meausred by Adverse Event reporting

Secondary ID(s)

CL3-20098-041

2004-003981-13

Source(s) of Monetary Support

Institut de Recherches Internationales Servier (France)

Ethics review

Status:
Approval date:
Contact:

Sub-Committee on Medical Research Ethics (TUJIKA) of the National Advisory Board on Health Care Ethics, Finland, 01/11/2004

Results

• Results available: Yes
• Date Completed: 30/06/2007