Clinical trial NCT03019822: Role of Dopamine, Serotonin and 5-HT2A Receptors in Emotion Processing
Official title: Role of Dopamine, Serotonin and 5-HT2A Receptors in Emotion Processing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Healthy
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2017-01-13
Enrollment: 28
Sex: ALL
Minimum age (years): 25
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The study will test the effect of dopamine, serotonin, and direct 5-HT2A receptor stimulation on empathy, mood perception, and amygdala activity to fearful stimuli. In addition, we predict associations between subjective effects/alterations in emotion processing tests and functional imaging (fMRI) activity.


Eligibility criteria: Inclusion Criteria:

1. Age between 25 and 50 years.
2. Sufficient understanding of the German language
3. Subjects understand the procedures and the risks associated with the study.
4. Participants must be willing to adhere to the protocol and sign the consent form.
5. Participants must be willing to refrain from taking illicit psychoactive substances during the study.
6. Participants must be willing to drink only alcohol-free liquids and no coffee, black or green tea, or energy drink after midnight of the evening before the study session, as well as during the study day.
7. Participants must be willing not to drive a traffic vehicle or to operate machines within 48 h after substance administration.
8. Women of childbearing potential must have a negative pregnancy test at the beginning of the study. Pregnancy tests are repeated before each study session. Women and men must agree to use an effective form of birth control (double-barrier method).
9. Body mass index 18-29 kg/m2.

Exclusion Criteria:

1. Chronic or acute medical condition
2. Hypertension (\>140/90 mmHg) or Hypotension (SBP\<85 mmHg)
3. Current or previous major psychiatric disorder
4. Psychotic disorder in first-degree relatives
5. Illicit substance use (with the exception of cannabis) more than 10 times or any time within the previous two months.
6. Pregnant or nursing women.
7. Participation in another clinical trial (currently or within the last 30 days)
8. Use of medications that may interfere with the effects of the study medications (any psychiatric medications).
9. fMRI related criteria including: metal implants (clips from operations, cochlea, large red/yellow tattoos in the neck area)
10. Tobacco smoking (\>10 cigarettes/day)
11. Consumption of alcoholic drinks (\>10/week)

Primary outcomes:
measure: Emotional enhancement as determined by fMRI
timeFrame: 12 hours
measure: fMRI brain activity
timeFrame: 1 hour
Secondary outcomes:
measure: Resting State fMRI
timeFrame: 1 hour
measure: Effect Modulation by personality traits (assessed with questionnaires),
timeFrame: 12 hours
measure: Effect Modulation by amygdala reactivity to fear (assessed in the fMRI)
timeFrame: 12 hours
measure: Effect Modulation by genetic polymorphisms (determined by genotyping of each subject)
timeFrame: 12 hours
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital Basel
state: Basel Stadt
Study officials:
affiliation: University Hospital, Basel, Switzerland
name: Matthias E Liechti, MD, MAS
role: PRINCIPAL_INVESTIGATOR
References: