Additional identifiers
EudraCT/CTIS number
2004-003981-13
IRAS number
ClinicalTrials.gov number
Protocol/serial number
CL3-20098-041
Study information
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.
Acronym
Study hypothesis
To assess the efficacy of agomelatine in the prevention of depressive relapse, in ambulatory patients suffering from major depressive disorder
Ethics approval(s)
Sub-Committee on Medical Research Ethics (TUJIKA) of the National Advisory Board on Health Care Ethics, Finland, 01/11/2004
Study design
Randomised double-blind parallel group study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Not specified
Study type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Major depressive disorder
Intervention
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
Intervention type
Drug
Pharmaceutical study type(s)
Phase
Not Applicable
Drug/device/biological/vaccine name(s)
Agomelatine
Primary outcome measure
Efficacy in the prevention of depressive relapse, measured by Hamilton Depression Rating Scale (HAMD) - questionnaire
Secondary outcome measures
Safety parameters, meausred by Adverse Event reporting
Overall study start date
09/02/2005
Overall study end date
30/06/2007
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Aged 18 to 65 years
2. Male or female
3. Out-patients
4. Requiring an antidepressant treatment
Participant type(s)
Patient
Age group
Adult
Lower age limit
18 Years
Sex
Both
Target number of participants
500
Participant exclusion criteria
1. All types of depression other than major depressive disorder
2. Severe or uncontrolled organic disease
3. Pregnant or breastfeeding women
Recruitment start date
09/02/2005
Recruitment end date
30/06/2007
Locations
Countries of recruitment
Australia, Finland, France, South Africa, United Kingdom
Study participating centre
Hôpital Albert Chenevier - 40 rue de Mesly
Créteil
94000
France
Sponsor information
Organisation
Institut de Recherches Internationales Servier (France)
Sponsor details
50 rue Carnot
Suresnes
92284
France
Sponsor type
Industry
Website
ROR
Funders
Funder type
Industry
Funder name
Institut de Recherches Internationales Servier (France)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Summary results are published on https://clinicaltrials.servier.com.
For interventional Phase III studies ending after the 1st January 2014, the results are/will be published in scientific literature.
Intention to publish date
Individual participant data (IPD) sharing plan
The datasets generated during and/or analysed during the current study will be available upon request from https://clinicaltrials.servier.com if a Marketing Authorisation has been granted after 1st January 2014.
IPD sharing plan summary
Available on request
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | No | No | |||
| Results article | results | 01/08/2009 | Yes | No | |
| Results article | results | 01/01/2013 | Yes | No |