Emotions, Dopamine, Brain and Body

Emotions Clinical Trial

— EMBODY  

Official title:

Influence of Domperidon on the Experience of Emotions, Brain and Bodily Activity

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06171087
• Other study ID #: Domperidone emotions
• Status: Recruiting
• Phase: Phase 4
• Start date: August 1, 2023
• Est. completion date: September 30, 2024

Study information

• Verified date: December 2023
• Source: German Institute of Human Nutrition
• Contact: Ignacio Rebollo, PhD
• Phone: 0049 33200 8
• Email: ignacio.rebollo[@]dife.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: September 30, 2024
• Est. primary completion date: March 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

Inclusion criteria

• 18-40 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)

Exclusion criteria

• 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).

• Professionally or privately being involved in the processing of metals.

• Have large tattoos (whole limbs).

• Being pregnant.

• Wear a intra-uterine device.

• Having tinnitus.

• Hypersensitivity or allergy to Domperidone or common excipients (lactose-1, corn Starch, potato starch, microcrystalline cellulose, castor oil, povidone, sodium lauryl sulfate, magnesium stearate, hypromellose)

Related Conditions & MeSH terms

• Emotions

Intervention

Drug:
• Domperidon
oral
• Placebo
oral tablet

Locations

Country	Name	City	State
Germany	German Institute of Human Nutrition	Potsdam	Brandenburg

Sponsors (1)

Lead Sponsor	Collaborator
German Institute of Human Nutrition

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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