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 |
| Secondary identifying numbers | CL1-20098-081 |
- 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
Scientific
University of Oxford
Department of Psychiatry
Warneford Hospital Headington
Oxford
OX3 7JX
United Kingdom
Study information
| 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 |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 |
| 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 |
| Completion date | 31/05/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 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
- England
- United Kingdom
Study participating centre
University of Oxford
Oxford
OX37JX
United Kingdom
OX37JX
United Kingdom
Sponsor information
Institut de Recherches Internationales Servier (France)
Industry
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 | Publication plan: Summary results are published in https://clinicaltrials.servier.com. |
| 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 and dissemination plan and IPD sharing statement updated.
24/01/2018: Publication plan and IPD sharing statement added.
29/11/2017: Results summary added.
