Emotions, Dopamine, Brain and Body

NCT ID: NCT06171087

Last Updated: 2023-12-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-01

Study Completion Date

2024-09-30

Brief Summary

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

Detailed Description

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Conditions

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Emotions

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Double blind, placebo controlled intervention with 20mg of Domperidon
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Domperidon

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

Group Type ACTIVE_COMPARATOR

Domperidon

Intervention Type DRUG

oral

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

oral tablet

Interventions

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Domperidon

oral

Intervention Type DRUG

Placebo

oral tablet

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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German Institute of Human Nutrition

OTHER

Sponsor Role lead

Responsible Party

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Prof. Dr. Soyoung Q Park

Prof. Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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German Institute of Human Nutrition

Potsdam, Brandenburg, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Ignacio Rebollo, PhD

Role: CONTACT

Phone: 0049 33200 8

Email: [email protected]

soyoung park, Prof PhD

Role: CONTACT

Phone: 0049 33200 88

Email: [email protected]

Facility Contacts

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Ignacio Rebollo

Role: primary

Other Identifiers

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Domperidone emotions

Identifier Type: -

Identifier Source: org_study_id