ClinicalTrials.gg
Status unknownNCT06171087EMBODYUpdated Dec 14, 2023

Emotions, Dopamine, Brain and Body

A Phase 4 interventional study of Domperidon and Placebo in Emotions, sponsored by German Institute of Human Nutrition. Status unknown at 1 site in Germany. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-12-14.

Sponsored by German Institute of Human Nutrition · Phase 4, Interventional, and Basic science

The sponsor has not verified this record recently (last verified Dec 2023), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled Aug 2023, registered Dec 2023).
Phase
Phase 4
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Emotions
03

In context

Lead sponsor

German Institute of Human Nutrition is the lead sponsor of 34 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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)
05

Study design

Phase
Phase 4
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
40 participants (estimated)

Study arms

  • Active comparator
    Domperidon

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

    Drug: Domperidon

  • Placebo comparator
    Placebo

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

    Drug: Placebo

Interventions

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 1-3 hour after drug administratrion

  2. 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

    Time frame: 1-3 hour after drug administratrion

  3. 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

    Time frame: 1-3 hour after drug administratrion

07

Study locations

1 of 1 sites recruiting
  • German Institute of Human Nutrition
    Potsdam, Brandenburg 14558, Germany
    • Ignacio Rebollo · Contact · 0049 33200
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Aug 2023 (actual). Primary completion is estimated for Mar 2024, 7 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 6, 2023
First posted
Dec 14, 2023
StartActual
Aug 1, 2023
Primary completionEst.
Mar 30, 2024
CompletionEst.
Sep 30, 2024
Last update
Dec 14, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 14, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06171087
Lead sponsor
German Institute of Human Nutrition
Responsible party
Prof. Dr. Soyoung Q Park (Prof. Dr., German Institute of Human Nutrition) — Principal investigator
First posted
Dec 14, 2023
Start date
Aug 1, 2023
Primary completion
Mar 30, 2024 (estimated)
Completion
Sep 30, 2024 (estimated)
Last update
Dec 14, 2023

Study contacts

Ignacio Rebollo, PhD
Contact
ignacio.rebollo@dife.de
0049 33200 8 ext. 2519
soyoung park, Prof PhD
Contact
soyoung.park@dife.de
0049 33200 88 ext. 2510

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Domperidone

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