Role of Dopamine, Serotonin and 5-HT2A Receptors in Emotion Processing
LAM
1 other identifier
interventional
28
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for early_phase_1 healthy
Started Feb 2017
Typical duration for early_phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 22, 2016
CompletedFirst Posted
Study publicly available on registry
January 13, 2017
CompletedStudy Start
First participant enrolled
February 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 11, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
September 4, 2018
CompletedOctober 15, 2018
October 1, 2018
1.5 years
December 22, 2016
October 12, 2018
Conditions
Outcome Measures
Primary Outcomes (2)
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
fMRI brain activity
Associations between subjective effects/alterations in emotion processing with fMRI amygdala BOLD activity
1 hour
Secondary Outcomes (4)
Resting State fMRI
1 hour
Effect Modulation by personality traits (assessed with questionnaires),
12 hours
Effect Modulation by amygdala reactivity to fear (assessed in the fMRI)
12 hours
Effect Modulation by genetic polymorphisms (determined by genotyping of each subject)
12 hours
Study Arms (4)
Placebo, LSD, d-Amphetamine, MDMA
OTHERCross-over within-subjects design with all treatment conditions, arms starting with either Placebo, lysergic acid diethylamide (LSD), d-Amphetamine or methylenedioxymethamphetamine (MDMA) and followed by all other drugs each separated by a wash-out phase
LSD, d-Amphetamine, MDMA, Placebo
OTHERCross-over within-subjects design with all treatment conditions, arms starting with either Placebo, LSD, d-Amphetamine or MDMA and followed by all other drugs each separated by a wash-out phase
d-Amphetamine, MDMA, LSD, Placebo
OTHERCross-over within-subjects design with all treatment conditions, arms starting with either Placebo, LSD, d-Amphetamine or MDMA and followed by all other drugs each separated by a wash-out phase
MDMA, LSD, Placebo, d-Amphetamine,,
OTHERCross-over within-subjects design with all treatment conditions, arms starting with either Placebo, LSD, d-Amphetamine or MDMA and followed by all other drugs each separated by a wash-out phase
Interventions
100ug per os, single dose
125mg per os, single dose
40.3mg per os, single dose
Capsules containing mannitol looking identical to the other drugs
Eligibility Criteria
You may qualify if:
- Age between 25 and 50 years.
- Sufficient understanding of the German language
- Subjects understand the procedures and the risks associated with the study.
- Participants must be willing to adhere to the protocol and sign the consent form.
- Participants must be willing to refrain from taking illicit psychoactive substances during the study.
- 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.
- Participants must be willing not to drive a traffic vehicle or to operate machines within 48 h after substance administration.
- 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).
- Body mass index 18-29 kg/m2.
You may not qualify if:
- Chronic or acute medical condition
- Hypertension (\>140/90 mmHg) or Hypotension (SBP\<85 mmHg)
- Current or previous major psychiatric disorder
- Psychotic disorder in first-degree relatives
- Illicit substance use (with the exception of cannabis) more than 10 times or any time within the previous two months.
- Pregnant or nursing women.
- Participation in another clinical trial (currently or within the last 30 days)
- Use of medications that may interfere with the effects of the study medications (any psychiatric medications).
- fMRI related criteria including: metal implants (clips from operations, cochlea, large red/yellow tattoos in the neck area)
- Tobacco smoking (\>10 cigarettes/day)
- Consumption of alcoholic drinks (\>10/week)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital Basel
Basel, Canton of Basel-City, 4031, Switzerland
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Matthias E Liechti, MD, MAS
University Hospital, Basel, Switzerland
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 22, 2016
First Posted
January 13, 2017
Study Start
February 1, 2017
Primary Completion
August 11, 2018
Study Completion
September 4, 2018
Last Updated
October 15, 2018
Record last verified: 2018-10