Trial Outcomes & Findings for Mood Effects of Serotonin Agonists Extended (NCT NCT03934710)
NCT ID: NCT03934710
Last Updated: 2023-11-29
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
56 participants
Primary outcome timeframe
End of session 5, approximately 2 weeks from baseline
Results posted on
2023-11-29
Participant Flow
Participant milestones
| Measure |
Placebo
Placebo
Placebo: Drug will be administered in solution form
|
Serotonin Agonist
13ug of serotonin agonist
Serotonin agonist: 13ug lysergic acid diethylamide
|
Serotonin Agonist
26ug of serotonin agonist: 26ug lysergic acid diethylamide
|
|---|---|---|---|
|
Overall Study
STARTED
|
18
|
19
|
19
|
|
Overall Study
COMPLETED
|
18
|
19
|
19
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Mood Effects of Serotonin Agonists Extended
Baseline characteristics by cohort
| Measure |
Placebo
n=18 Participants
Placebo
Placebo: Drug will be administered in solution form
|
Serotonin Agonist 13ug
n=19 Participants
13ug of serotonin agonist
Serotonin agonist: 13ug lysergic acid diethylamide
|
Serotonin Agonist 26 ug
n=19 Participants
26ug of serotonin agonist
Serotonin agonist: 26ug lysergic acid diethylamide
|
Total
n=56 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
18 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
56 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
37 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
36 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
18 participants
n=5 Participants
|
19 participants
n=7 Participants
|
19 participants
n=5 Participants
|
56 participants
n=4 Participants
|
|
Education - High School Education
|
18 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
56 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: End 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.
Outcome measures
| Measure |
Placebo
n=18 Participants
Placebo
Placebo: Drug will be administered in solution form
|
Serotonin Agonist 13ug
n=19 Participants
13ug of serotonin agonist
Serotonin agonist: 13ug lysergic acid diethylamide
|
Serotonin Agonist 26ug
n=19 Participants
Serotonin agonist: 26 ug lysergic acid diethyl amide
|
|---|---|---|---|
|
DASS-21
|
2.9 units on a scale
Standard Deviation 3
|
2.7 units on a scale
Standard Deviation 2.9
|
4.5 units on a scale
Standard Deviation 3.7
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serotonin Agonist 13 ug
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serotonin Agonist 26 ug
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place