FindTrial
Sign In

Mood Effects of Serotonin Agonists Extended

Mood Effects of Serotonin Agonists Extended

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03934710
Acronym
MESA-E
Enrollment
56
Registered
2019-05-02
Start date
2019-04-20
Completion date
2021-06-07
Last updated
2023-11-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Brief summary

In this study we are examining the effects of repeated very low doses of serotonin agonists on mood individuals with negative mood.

Detailed description

Here, we are examining the effects of four repeated low doses of lysergic acid diethylamide (LSD), compared to placebo, administered to healthy adults at 3-4 day intervals, on mood, cognitive performance and responses to emotional tasks

Interventions

DRUGPlacebo

Drug will be administered in solution form

DRUGSerotonin agonist - 13ug

13ug lysergic acid diethylamide

DRUGSerotonin agonist - 26ug

26ug lysergic acid diethylamide

Sponsors

National Institute on Drug Abuse (NIDA)
CollaboratorNIH
University of Chicago
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Intervention model description

Randomized

Eligibility

Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes

Inclusion criteria

* English fluency * High school level education * BMI between 19 and 30

Exclusion criteria

* Diagnosed medical condition * women who are nursing, pregnant, or plan to become pregnant within 3 months * History of psychotic disorder or family history of psychotic disorder

Design outcomes

Primary

MeasureTime frameDescription
DASS-21End of session 5, approximately 2 weeks from baselineThe primary outcome measure is the depression anxiety and stress scale (DASS) 21. This self-report measure contains 21 items and the range of scores for depression is 0-42, anxiety 0-42, and stress 0-42. Our primary outcome measure is total depression scale ratings during session 5, with lower scores indicating lower ratings of depression.

Countries

United States

Participant flow

Participants by arm

ArmCount
Placebo
Placebo Placebo: Drug will be administered in solution form
18
Serotonin Agonist 13ug
13ug of serotonin agonist Serotonin agonist: 13ug lysergic acid diethylamide
19
Serotonin Agonist 26 ug
26ug of serotonin agonist Serotonin agonist: 26ug lysergic acid diethylamide
19
Total56

Baseline characteristics

CharacteristicPlaceboSerotonin Agonist 13ugSerotonin Agonist 26 ugTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
18 Participants19 Participants19 Participants56 Participants
Education - High School Education18 Participants19 Participants19 Participants56 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
1 Participants2 Participants2 Participants5 Participants
Race (NIH/OMB)
Black or African American
0 Participants2 Participants1 Participants3 Participants
Race (NIH/OMB)
More than one race
5 Participants4 Participants3 Participants12 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
12 Participants11 Participants13 Participants36 Participants
Region of Enrollment
United States
18 participants19 participants19 participants56 participants
Sex: Female, Male
Female
7 Participants6 Participants6 Participants19 Participants
Sex: Female, Male
Male
11 Participants13 Participants13 Participants37 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 180 / 190 / 19
other
Total, other adverse events
0 / 180 / 190 / 19
serious
Total, serious adverse events
0 / 180 / 190 / 19

Outcome results

Primary

DASS-21

The primary outcome measure is the depression anxiety and stress scale (DASS) 21. This self-report measure contains 21 items and the range of scores for depression is 0-42, anxiety 0-42, and stress 0-42. Our primary outcome measure is total depression scale ratings during session 5, with lower scores indicating lower ratings of depression.

Time frame: End of session 5, approximately 2 weeks from baseline

ArmMeasureValue (MEAN)Dispersion
PlaceboDASS-212.9 units on a scaleStandard Deviation 3
Serotonin Agonist 13ugDASS-212.7 units on a scaleStandard Deviation 2.9
Serotonin Agonist 26ugDASS-214.5 units on a scaleStandard Deviation 3.7

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026