Serotonin and decision-making

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Radboud Universiteit Nijmegen

Participant type

Healthy volunteers

Age range

18-64 years

Gender

Male and Female

Therapeutic area

Psychiatry and Psychology [F] - Behavior and Behavior Mechanisms [F01]

Trial duration

6 Mar 2025 → 12 Feb 2026

Decision date (initial)

2024-10-22

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

NWO VIDI grant

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Others

The role of serotonin in learning and decision-making: a behavioural study

Secondary objectives 1

1. Relate subjects' behaviour to their individual characteristics, including perfectionism, high sensitivity, and impulsivity.

Conditions and MedDRA coding

None

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 2

1. Healthy volunteers between 18-40 years of age
2. For people able to bear children: negative pregnancy test taken during the intake ses-sion.

Exclusion criteria 22

1. (Known) hypersensitivity to escitalopram
2. (History of) epilepsy in adulthood (i.e., no insult after 18 years of age, no current medication for epilepsy and no insult in the last five years)
3. • Use of any medication (prescribed/over the counter, including antibiotics and antihistamines but excluding paracetamol and contraceptive medication), and/or use of recreational drugs, or herbal remedies containing St John’s worth, during the study or within two weeks prior to the first behavioural session.
4. Average use of psychotropic medication/recreational drugs once a week or more
5. Unwillingness to refrain from drinking alcohol/only moderately consume alcohol for the duration of drug administration
6. Possible pregnancy or breastfeeding
7. No appropriate contraception (for people who can bear children)
8. First degree family member with schizophrenia, bipolar disorder, or (known) suicide attempt.
9. Periods of more than 3 months where cannabis was used weekly or more in the last 6 months
10. Prior to the testing sessions, use of alcohol within the last 24 hours before each measurement.
11. Lifetime history of attempted suicide or current suicidal ideation.
12. Habitual smoking, i.e., more than a pack of cigarettes per week and/or a self-reported inability or unease to cease smoking for 24 hours to testing.
13. Abnormal hearing or (uncorrected) vision.
14. Irregular sleep/wake rhythm (e.g., regular nightshifts or cross-time zone travel).
15. Inability to complete the behavioural training successfully.
16. Lifetime diagnosis of major depression, bipolar disorder, schizophrenia spectrum disorder, anorexia nervosa, personality disorder, and post-traumatic stress disorder
17. History of pharmacological treatment of a psychiatric disorder (including MAO inhibitors, antidepressants, antipsychotic drugs)
18. Lifetime diagnosis of relevant neurological disorder
19. Current or history of severe substance use disorder (opiate, LSD, (meth)amphetamine, cocaine, solvents, XTC, MDMA, 3-MMC, GHB, heroin, nitrous oxide, or barbiturate), or alcohol use disorder.
20. Average use of more than 3 alcohol beverages daily
21. History of regular fainting (e.g., vasovagal reflex syncope).
22. (History of) clinically significant/relevant hepatic, cardiac, obstructive respiratory, renal, gastrointestinal, cerebrovascular, cardiovascular, metabolic, endocrine, pancreatic, ocular or pulmonary disease/disorders

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Behavioural performance (accuracy, reaction times) on the resource investment task

Secondary endpoints 2

1. Responses to a series of questionnaires that quantify individual characteristics
2. Behavioural performance (accuracy, reaction times) on 4 behavioural tasks

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Radboud Universiteit Nijmegen

Sponsor organisation

Radboud Universiteit Nijmegen

Address

Houtlaan 4

City

Nijmegen

Postcode

6525 XZ

Country

Netherlands

Scientific contact point

Organisation

Radboud Universiteit Nijmegen

Contact name

Project Coordinator

Public contact point

Organisation

Radboud Universiteit Nijmegen

Contact name

Project Coordinator

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 9 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications