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

Not Applicable

Completed

• Conditions: Major Depressive Disorder; Mental and Behavioural Disorders

• Registration Number: ISRCTN75872983
• Lead Sponsor: Institut de Recherches Internationales Servier (France)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-08-04
• Study Completion: 2013-05-31
• Last Update Posted: 21 May 2018

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 128

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Emotional blunting will be assessed by using the Oxford Depression Questionnaire (ODQ) at week 0/ week 2/ week 8 and end of study<br>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<br>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

Name	Time	Method
o secondary outcome measures