Condition category
Mental and Behavioural Disorders
Date applied
24/03/2011
Date assigned
04/05/2011
Last edited
05/11/2013
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration and not expected to be available in the future

Trial website

Contact information

Type

Scientific

Primary contact

Prof Tudor Udristoiu

ORCID ID

Contact details

Spitalul Clinic de Neuropsihiatrie Craiova
Clinica 1 Psihiatrie
Aleea Potelu No 24
Craiova
200317
Romania

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

CL3-20098-083

Study information

Scientific title

Early effect of agomelatine on general interest in outpatients suffering major depressive disorder: a parallel group, randomised, double-blind, multicentre study

Acronym

Study hypothesis

To assess the early effect of agomelatine on general interest in outpatients suffering from major depressive disorder

Please note tht as of 26/11/2012, the anticipated end date for this trial was updated from 30/09/2012 to 30/03/2013.

Ethics approval

Ethics approval was obtained before recruitment of the first participants

Study design

Parallel group randomised double-blind multicentre study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Depression

Intervention

Therapeutic oral doses of agomelatine and therapeutic oral doses of selective serotonin reuptake inhibitors (SSRI) for 12 weeks, a randomised double-blind period

Intervention type

Drug

Phase

Not Applicable

Drug names

Agomelatine

Primary outcome measures

General interest score obtained from the Visual Analogue Scale (VAS) reflecting the item 13 of the QIDS-SR 16 scale

Secondary outcome measures

To provide additional efficacy, safety and tolerability data on agomelatine

Overall trial start date

23/05/2011

Overall trial end date

30/03/2013

Reason abandoned

Eligibility

Participant inclusion criteria

1. Male or female outpatients
2. Aged between 18 and 65 years (inclusive) at the time of selection
3. Fulfilling Diagnostic and Statistical Manual of Mental Disorders 4th edition, Text Revision (DSM-IV-TR) criteria for current major depressive episode (MDE) < = 12months, of moderate to severe intensity
4. Major depressive episode diagnosis documented using the brief structured Mini-International Neuropsychiatric Interview (M.I.N.I.)
5. Quick Inventory of Depressive Symptomatology Self-Report (QIDS-SR16) item 13 (General interest) > = 2
6. Hamilton Rating Scale for Depression (HAM-D-17) total score > = 22
7. Clinical Global Impression - Severity (CGI-S) (Severity of illness) > = 4 (moderately to severely ill)
8. Requiring an antidepressant treatment

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

300

Participant exclusion criteria

1. Patient fulfilling DSM-IV-TR criteria for a MDE of mild intensity or severe episode with psychotic features,catatonic features or with duration <4 weeks
2. All types of depression other than MDD, according to DSM-IV-TR criteria
3. Marked suicidal intent and/or known suicidal tendencies for the current episode defined as a score of 4 at the item 3 of the HAM-D-17 and/or in the investigator's opinion based on the patient's medical history, previoussuicide attempts, quality of social and familial support
4. Pregnancy, breastfeeding or possibility of becoming pregnant during the study and without an effective contraception
5. Hepatic impairment
6. Severe renal insufficiency

Recruitment start date

23/05/2011

Recruitment end date

30/03/2013

Locations

Countries of recruitment

Romania

Trial participating centre

Spitalul Clinic de Neuropsihiatrie Craiova
Craiova
200317
Romania

Sponsor information

Organisation

Institut de Recherches Internationales Servier (France)

Sponsor details

50 rue Carnot
Suresnes
92284
France

Sponsor type

Industry

Website

http://www.servier.com/

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

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes