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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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21 May 2018 |
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Main ID: |
ISRCTN75872983 |
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Date of registration:
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04/08/2011 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Evaluation of the effect of agomelatine and escitalopram on emotions and motivation in healthy male and female volunteers
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Scientific title:
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Evaluation of the effect of agomelatine and escitalopram on emotions and motivation in healthy male and female volunteers |
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Date of first enrolment:
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01/10/2011 |
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Target sample size:
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128 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN75872983 |
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Study type:
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Interventional |
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Study design:
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Randomised double-blind placebo-controlled multicentric study (Treatment)
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Phase:
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Not Applicable
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Countries of recruitment
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United Kingdom
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Contacts
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Guy
Goodwin |
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Address:
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University of Oxford
Department of Psychiatry
Warneford Hospital Headington
OX3 7JX
Oxford
United Kingdom |
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Telephone:
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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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
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
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Major Depressive Disorder
Mental and Behavioural Disorders
Major Depressive Disorder
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Intervention(s)
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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
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Primary Outcome(s)
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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
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Secondary Outcome(s)
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No secondary outcome measures
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Secondary ID(s)
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CL1-20098-081
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Source(s) of Monetary Support
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Institut de Recherches Internationales Servier (France)
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Ethics review
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Status:
Approval date:
Contact:
Ethics approval was obtained before recruitment of the first participants
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Results
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Results available:
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Yes |
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Date Posted:
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Date Completed:
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31/05/2013 |
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URL:
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