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Register:	ISRCTN
Last refreshed on:	21 May 2018
Main ID:	ISRCTN68222771
Date of registration:	31/03/2006
Prospective Registration:	No
Primary sponsor:	Institut de Recherches Internationales Servier (France)
Public title:	Efficacy of agomelatine given orally on the 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 SSRI drug. Twelve-week treatment plus optional continuation for 12 weeks.
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.
Date of first enrolment:	07/10/2005
Target sample size:	400
Recruitment status:	Completed
URL:	http://isrctn.com/ISRCTN68222771
Study type:	Interventional
Study design:	Randomised double-blind flexible-dose international multicentre study with parallel groups versus SSRI drug (Treatment)
Phase:	Not Applicable

Countries of recruitment
Austria	Belgium	Denmark	France	Hungary	Italy	Norway	Poland
Portugal	Spain

Contacts

Name:
Address:
Telephone:
Email:
Affiliation:

Name:	Thierry Bougerol
Address:	CHU de Grenoble-Hopital Sud Psychiatrie de l'Adulte BP 185 Cedex 09 38042 Grenoble France
Telephone:
Email:
Affiliation:

Key inclusion & exclusion criteria

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
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

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Major depressive disorder
Mental and Behavioural Disorders
Major depressive disorder

Intervention(s)

Agomelatine versus SSRI drug

Primary Outcome(s)

Quality of sleep

Secondary Outcome(s)

1. Other sleep patterns
2. Quality of life
3. Daytime drowsiness
4. Residual symptoms of depression

Secondary ID(s)

2005-002388-95

CL3-20098-048

Source(s) of Monetary Support

Institut de Recherches Internationales Servier (France)

Secondary Sponsor(s)

Ethics review

Status:
Approval date:
Contact:

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

Results

Results available:	Yes
Date Posted:
Date Completed:	30/04/2008
URL:

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