EmotionsPhase 4EMBODYNCT06171087
Emotions, Dopamine, Brain and Body
A Phase 4 study testing Domperidon in people with Emotions, run by German Institute of Human Nutrition at 1 site in Germany.
Trial summary
The study will examine the influence of domperidon (20mg) on brain and hebavioral responses to emotional stimuli (videos) using fMRI Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Emotions
- What is being tested?
- Domperidon
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- 1 Aug 2023to 30 Sep 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Show all 11Show fewer
- 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)
Who cannot join
- 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.
Show all 21Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
German Institute of Human Nutrition
Potsdam, Brandenburg, 14558
Ignacio Rebollo, 0049 33200 ext. 2519
About this study
Official title: Influence of Domperidon on the Experience of Emotions, Brain and Bodily Activity
The study will examine the influence of domperidon (20mg) on brain and hebavioral responses to emotional stimuli (videos) using fMRI
- Conditions
- Emotions
- Being tested
- Domperidon, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DomperidonDrug
oral
PlaceboDrug
oral tablet
| Study group | Role | What they receive |
|---|---|---|
| Domperidon | Active comparator | Participants recieve 10mg of Domperidon, 45 minutes before the start of the experiment Receives: Drug: Domperidon |
| Placebo | Placebo comparator | Participants recieve a placebo pill, 45 minutes before the start of the experiment Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 1-3 hour after drug administratrion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2023
- Study start1 Aug 2023
- Primary completion30 Mar 2024 (estimated)
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EmotionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Double blind, placebo controlled intervention with 20mg of Domperidon
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- German Institute of Human Nutrition
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Soyoung Q Park, German Institute of Human Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06171087
- Sponsor's protocol ID
- Domperidone emotions
- Acronym
- EMBODY
- Status last verified
- Dec 2023
- First submitted
- 6 Dec 2023
- Last updated
- 14 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Domperidon on the Experience of Emotions, Brain and Bodily Activity
- ClinicalTrials.gov ID
- NCT06171087
- Acronym / sponsor ID
- EMBODY / Domperidone emotions
- Conditions
- Emotions
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- German Institute of Human NutritionUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 30 Mar 2024 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 14 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study will examine the influence of domperidon (20mg) on brain and hebavioral responses to emotional stimuli (videos) using fMRI
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double blind, placebo controlled intervention with 20mg of Domperidon
| Arm | Type | Receives |
|---|---|---|
| Domperidon | Active comparator | Drug: DomperidonParticipants recieve 10mg of Domperidon, 45 minutes before the start of the experiment |
| Placebo | Placebo comparator | Drug: PlaceboParticipants recieve a placebo pill, 45 minutes before the start of the experiment |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (21 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Domperidonoral | Drug | Domperidon |
| Placebooral tablet | Drug | Placebo |
Primary outcome
Brain responses to emotions
Time frame: 1-3 hour after drug administratrion
fMRI brain responses to emotional videos comparing placebo vs domperidon condition. Specifically: dampened brain response to disgust and high arousing videos in domperidon condition
Body (stomach, heart, skin conductance) response to emotions
Time frame: 1-3 hour after drug administratrion
Physiological responses to emotional videos comparing placebo vs domperidon condition. Specifically: Reduction in Tachyhastria for disgust and high arousing videos in domperidone condition
Behavioral responses to emotions
Time frame: 1-3 hour after drug administratrion
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Emotions
RecruitingObservational study
A Prospective Study of Anxiety, Depression, and Bipolar Disorder in People
Anxiety Disorders, Depressive Disorder
Not yet recruiting
Investigation of the Gut-Brain Axis in Alcohol Use Disorder
Alcohol Use Disorder (AUD), Alcohol Abstinence
Recruiting
DBT-P Treatment Study
Emotion Dysregulation
Active, not recruiting
Online Written Imagery Rescripting for Shame and Negative Self-Cognitions in Malaysian Adults With Childhood Emotional Neglect
Shame, Childhood Emotional Neglect
Recruiting
The Coma Family Program (COMA-F): A Resilience Program for Caregivers of Patients With Severe Acute Brain Injury
Caregiver Distress, Emotional Distress
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Domperidon in people with Emotions, run by German Institute of Human Nutrition at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ignacio Rebollo, PhD (0049 33200 8 ext. 2519, ignacio.rebollo@dife.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brain responses to emotions (time frame: 1-3 hour after drug administratrion). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2023.