Emotions, Dopamine, Brain and Body

NCT06171087 | Unknown Phase 4

• 1 other identifier: Domperidone emotions
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The study will examine the influence of domperidon (20mg) on brain and hebavioral responses to emotional stimuli (videos) using fMRI

Conditions

Emotions

Outcome Measures

Primary Outcomes (3)

• Brain responses to emotions

  fMRI brain responses to emotional videos comparing placebo vs domperidon condition. Specifically: dampened brain response to disgust and high arousing videos in domperidon condition

  1-3 hour after drug administratrion

• Body (stomach, heart, skin conductance) response to emotions

  Physiological responses to emotional videos comparing placebo vs domperidon condition. Specifically: Reduction in Tachyhastria for disgust and high arousing videos in domperidone condition

  1-3 hour after drug administratrion

• Behavioral responses to emotions

  Changes in subjective reports to emotional videos comparing placebo vs domperidon condition. Specifically: Reduction in disgust and arousal ratings to disgust and high arousing videos

  1-3 hour after drug administratrion

Study Arms (2)

Domperidon

ACTIVE COMPARATOR

Participants recieve 10mg of Domperidon, 45 minutes before the start of the experiment

Drug: Domperidon

Placebo

PLACEBO COMPARATOR

Participants recieve a placebo pill, 45 minutes before the start of the experiment

Drug: Placebo

Interventions

Domperidon DRUG

oral

Domperidon

Placebo DRUG

oral tablet

Placebo

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• years old men and women
• Consent to participate
• Fluent in German
• Physically and mentally healthy. No regular medication
• BMI 18-25 kg/m2
• Alcohol consumption less than 15 glasses a week (wine / beer, a glass of higher-percentage alcohol counts as two glasses of beer)
• No illegal drug consumption in the week previous to the experiment
• No smoking
• No extreme athletes
• No vegetarians or vegans or any other dietary restrictions due to allergies or intolerances
• Normal day-night rhythm (no shift work)

You may not qualify if:

• Former or current illnesses of:
• Brain or mind (including anxiety disorders, depression, eating disorders, personality disorders, alcohol, drugs or drug dependence, neurological disorders other than occasional headache, psychiatric or neurological abnormalities)
• Heart or blood circulation
• Gastro-intestinal or endocrine disorders
• Other serious past or present medical conditions (for example, metabolic syndrome, diabetes).
• Current medication and medication over a period of two weeks prior to the examination.
• Other serious health problems or present strong mental or physical stress.
• No current infection or excessive stress
• Missing consent to receive information about incidental findings from the MRI
• Tendency to claustrophobia, dizziness or panic attacks.
• Wear a non-removable pacemaker, defibrillator, hearing aid, drug pump, neurostimulator or implant with solenoid valve (e.g., artificial bowel outlet).
• Metal parts or implants inside the body, for example, due to surgery or injury with a metallic foreign object (e.g., hip replacements, artificial joints, heart valves, vessel occlusions or dilatations, surgical clips, bone screws or plates, coil, shunts, catheters, electrodes, coils, radiation sources, shrapnel, projectiles, stents).
• Have non-removable metal parts or metal-containing devices on or in the body.
• Have ferromagnetic metal parts or implants inside the body (e.g., hip replacements, artificial joints, heart valves, vessel occlusions or dilatations, surgical clips, bone screws or plates, coils, shunts, catheters, electrodes, coils, radiation sources, shrapnel, projectiles, stents)
• Wearing magnetically fixed implants (e.g., amalgam fillings, glass eye).

Sponsors & Collaborators

• German Institute of Human Nutrition: lead

Study Sites (1)

German Institute of Human Nutrition

Potsdam, Brandenburg, 14558, Germany

RECRUITING

MeSH Terms

Interventions

Domperidone

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Central Study Contacts

Ignacio Rebollo, PhD

CONTACT

0049 33200 8; ignacio.rebollo@dife.de

soyoung park, Prof PhD

CONTACT

0049 33200 88; soyoung.park@dife.de

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Model Details: Double blind, placebo controlled intervention with 20mg of Domperidon

Study Record Dates

• First Submitted: December 6, 2023
• First Posted: December 14, 2023
• Study Start: August 1, 2023
• Primary Completion: March 30, 2024
• Study Completion: September 30, 2024
• Last Updated: December 14, 2023

Record last verified: 2023-12

Locations

DE (1)