Evaluation of the effect of agomelatine and escitalopram on emotions and motivation in healthy male and female volunteers

ISRCTN	ISRCTN75872983
DOI	https://doi.org/10.1186/ISRCTN75872983
Protocol serial number	CL1-20098-081
Sponsor	Institut de Recherches Internationales Servier (France)
Funder	Institut de Recherches Internationales Servier (France)

Submission date: 24/06/2011
Registration date: 04/08/2011
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 Guy Goodwin
Scientific

University of Oxford
Department of Psychiatry
Warneford Hospital Headington
Oxford
OX3 7JX
United Kingdom

Study information

Primary study design	Interventional
Study design	Randomised double-blind placebo-controlled multicentric study
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Evaluation of the effect of agomelatine and escitalopram on emotions and motivation in healthy male and female volunteers
Study objectives	Current study hypothesis as of 23/07/2012: To assess the effects of agomelatine and escitalopram on emotional blinding, emotional processing and motivation during 9 weeks treatment in healthy male and female volunteers Previous study hypothesis until 23/07/2012: To assess the effects of agomelatine and escitalopram on emotional blinding, emotional processing and motivation during 8 weeks treatment in healthy male and female volunteers
Ethics approval(s)	Ethics approval was obtained before recruitment of the first participants
Health condition(s) or problem(s) studied	Major Depressive Disorder
Intervention	1. A randomised, double-blind study with parallel group of therapeutic oral doses of agomelatine and escitalopram 2. 9 weeks treatment period and 1 week of follow-up period
Intervention type	Drug
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Agomelatine, escitalopram
Primary outcome measure(s)	1. Emotional blunting will be assessed by using the Oxford Depression Questionnaire (ODQ) at week 0/ week 2/ week 8 and end of study 2. Emotional processing: Facial expression recognition task/Emotional categorisation task/the faces dot-probe task/Emotional memory free recall task/Emotional memory forced recognition task at week 1 and week 8 3. Motivation: Sensitivity to reward and punishment task/Motivation and effort duration task/ Gait speed task/Motivation score at week 0/ week 1/ week 2 and week 8
Key secondary outcome measure(s)	No secondary outcome measures
Completion date	31/05/2013

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	128
Key inclusion criteria	1. Healthy male and female volunteers aged between 18 and 45 years (both inclusive) 2. A Body index (BMI) between 18.0 and 30.0 (both inclusive) 3. Ability and/or willingness to undergo psychological test battery, motivation test battery and self-rating questionnaires or clinician-rated questionnaires including sexual activity questionnaire 4. Speaks fluent English 5. Negative urine pregnancy test for women of childbearing potential at inclusion 6. Using consistently and correctly method of birth control such as implants, injectables, oral contraceptives, some intra-uterine device or surgical sterilization 7. Negative drug abuse and breath ethanol test
Key exclusion criteria	1. Any surgical procedure since the selection visit 2. Intake of any medication (except paracetamol at the dose of 1.5g/day and oral contraceptives) since the selection visit 3. Previous experience of Emotional Test Battery
Date of first enrolment	01/10/2011
Date of final enrolment	31/05/2013

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

University of Oxford

Oxford
OX37JX
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
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
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

18/04/2018: Internal review.
28/03/2018: Publication and dissemination plan and IPD sharing statement updated.
24/01/2018: Publication plan and IPD sharing statement added.
29/11/2017: Results summary added.