Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
CL1-20098-081
Study information
Scientific title
Evaluation of the effect of agomelatine and escitalopram on emotions and motivation in healthy male and female volunteers
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(s)
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
Study setting(s)
Hospital
Study 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
Pharmaceutical study type(s)
Phase
Not Applicable
Drug/device/biological/vaccine name(s)
Agomelatine, escitalopram
Primary outcome measure
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 study start date
01/10/2011
Overall study end date
31/05/2013
Reason abandoned (if study stopped)
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(s)
Patient
Age group
Adult
Lower age limit
18 Years
Sex
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
England, United Kingdom
Study 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
ROR
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
Publication plan:
Summary results are published in https://clinicaltrials.servier.com.
Intention to publish date
Individual participant data (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.
IPD sharing plan summary
Available on request
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | No | No |