Early effect of agomelatine on general interest in outpatients suffering major depressive disorder

ISRCTN	ISRCTN28327843
DOI	https://doi.org/10.1186/ISRCTN28327843
Secondary identifying numbers	CL3-20098-083

Submission date: 24/03/2011
Registration date: 04/05/2011
Last edited: 18/04/2018

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

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

Contact information

Prof Tudor Udristoiu
Scientific

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

Study information

Study design	Parallel group randomised double-blind multicentre study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title	Early effect of agomelatine on general interest in outpatients suffering major depressive disorder: a parallel group, randomised, double-blind, multicentre study
Study objectives	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(s)	Ethics approval was obtained before recruitment of the first participants
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Agomelatine
Primary outcome measure	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 study start date	23/05/2011
Completion date	30/03/2013

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	300
Key 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
Key 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
Date of first enrolment	23/05/2011
Date of final enrolment	30/03/2013

Locations

Countries of recruitment

Romania

Study participating centre

Spitalul Clinic de Neuropsihiatrie Craiova

Craiova
200317
Romania

Sponsor information

Institut de Recherches Internationales Servier (France)
Industry

50 rue Carnot
Suresnes
92284
France

Website	http://www.servier.com/
"ROR"	https://ror.org/034e7c066

Funders

Funder type

Industry

Institut de Recherches Internationales Servier (France)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
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.
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.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Basic results				No	No

Editorial Notes

18/04/2018: Internal review.
28/03/2018: Publication plan and IPD sharing statement updated.
25/01/2018: Publication plan and IPD sharing statement added.
19/12/2017: results summary added.