Condition category
Mental and Behavioural Disorders
Date applied
24/06/2011
Date assigned
04/08/2011
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 Guy Goodwin

ORCID ID

Contact details

University of Oxford
Department of Psychiatry
Warneford Hospital Headington
Oxford
OX37JX
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

CL1-20098-081

Study information

Scientific title

Acronym

Study hypothesis

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

Ethics approval was obtained before recruitment of the first participants

Study design

Randomised double-blind placebo-controlled multicentric study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial 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

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 names

Agomelatine, escitalopram

Primary outcome measures

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

Secondary outcome measures

No secondary outcome measures

Overall trial start date

01/10/2011

Overall trial end date

31/05/2013

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

128

Participant 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

Recruitment start date

01/10/2011

Recruitment end date

31/05/2013

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Oxford
Oxford
OX37JX
United Kingdom

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