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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN75872983
Enrollment
128
Registered
2011-08-04
Start date
2011-10-01
Completion date
Unknown
Last updated
2018-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Major Depressive Disorder Mental and Behavioural Disorders Major Depressive Disorder

Interventions

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

Sponsors

Institut de Recherches Internationales Servier (France)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
No secondary outcome measures

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 4, 2026