Additional identifiers
EudraCT/CTIS number
2005-002388-95
IRAS number
ClinicalTrials.gov number
Protocol/serial number
CL3-20098-048
Study information
Scientific title
Efficacy of agomelatine (25 to 50 mg/day) given orally on quality of remission in elderly depressed patients, after a 12-week treatment period.A randomised, double-blind, flexible-dose international multicentre study with parallel groups versus paroxetine (20 to 30 mg/day).Twelve-week treatment plus optional continuation for 12 weeks.
Acronym
Study hypothesis
To show the efficacy of agomelatine in improving the quality of remission in elderly depressed patients.
On 26/11/2012 the anticipated end date of this trial was updated from 30/10/2007 to 30/04/2008.
Ethics approval(s)
First approved by the Ethical Committee of Clinical Investigations, Clinical Hospital of San Carlos (Comite Etico de Investigacion Clinica, Hospital Clinico, San Carlos) on 05/08/2005 in Spain, reference number: 05/165-R
Study design
Randomised double-blind flexible-dose international multicentre study with parallel groups versus SSRI drug
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
Agomelatine versus SSRI drug
Intervention type
Drug
Pharmaceutical study type(s)
Phase
Not Applicable
Drug/device/biological/vaccine name(s)
Agomelatine
Primary outcome measure
Quality of sleep
Secondary outcome measures
1. Other sleep patterns
2. Quality of life
3. Daytime drowsiness
4. Residual symptoms of depression
Overall study start date
07/10/2005
Overall study end date
30/04/2008
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Out-patients aged at least 60 years with recurrent major depressive episode according to diagnostic and statistical manual of mental disorders (DSM) IV
Participant type(s)
Patient
Age group
Adult
Sex
Both
Target number of participants
400
Participant exclusion criteria
1. Patients treated with electroconvulsive therapy (ECT) within the last three months
2. Insight-oriented and structured psychotherapy started within the three months before inclusion
3. Light-therapy started within two weeks before inclusion
4. Current diagnosis of neurological disorders
5. Cognitive dysfunction
6. Severe or uncontrolled organic disease, likely to interfere with the conduct of the study
Recruitment start date
07/10/2005
Recruitment end date
30/04/2008
Locations
Countries of recruitment
Austria, Belgium, Denmark, France, Hungary, Italy, Norway, Poland, Portugal, Spain
Study participating centre
CHU de Grenoble-Hopital Sud
Grenoble
38042
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 in 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 | 01/01/2013 | Yes | No |