Role of Dopamine, Serotonin and 5-HT2A Receptors in Emotion Processing

Healthy Clinical Trial

— LAM  

Official title:

Role of Dopamine, Serotonin and 5-HT2A Receptors in Emotion Processing

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03019822
• Other study ID #: BASEC 2016-01827
• Status: Completed
• Phase: Early Phase 1
• Start date: February 1, 2017
• Est. completion date: September 4, 2018

Study information

• Verified date: October 2018
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: September 4, 2018
• Est. primary completion date: August 11, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 50 Years

Eligibility

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)

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• LSD
100ug per os, single dose
• MDMA
125mg per os, single dose
• Amphetamine
40.3mg per os, single dose
• Placebo
Capsules containing mannitol looking identical to the other drugs

Locations

Country	Name	City	State
Switzerland	University Hospital Basel	Basel	Basel Stadt

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Emotional enhancement as determined by fMRI	Emotional enhancement (empathy, oxytocin, mood perception, fMRI amygdala blood oxygen level-dependent (BOLD) signal reactivity to fearful stimuli)	12 hours
Primary	fMRI brain activity	Associations between subjective effects/alterations in emotion processing with fMRI amygdala BOLD activity	1 hour
Secondary	Resting State fMRI	Association between emotional enhancement and resting state fMRI neuronal activity	1 hour
Secondary	Effect Modulation by personality traits (assessed with questionnaires),	Effect modulation by personality traits (assessed with questionnaires), baseline amygdala reactivity to fear in the fMRI, and genetic polymorphisms determined by genotyping of each subject	12 hours
Secondary	Effect Modulation by amygdala reactivity to fear (assessed in the fMRI)	Effect modulation by personality traits (assessed with questionnaires), baseline amygdala reactivity to fear in the fMRI, and genetic polymorphisms determined by genotyping of each subject	12 hours
Secondary	Effect Modulation by genetic polymorphisms (determined by genotyping of each subject)	Effect modulation by personality traits (assessed with questionnaires), baseline amygdala reactivity to fear in the fMRI, and genetic polymorphisms determined by genotyping of each subject	12 hours