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Clinical Trials/NCT03934710
NCT03934710CompletedPhase 1

Mood Effects of Serotonin Agonists Extended

University of Chicago1 site in 1 country56 target enrollmentStarted: April 20, 2019Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Completed
Enrollment
56
Locations
1
Primary Endpoint
DASS-21

Study Overview

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Basic Science
Masking
Triple (Participant, Care Provider, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 40 Years (Adult)
Sex
All
Accepts 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

Arms & Interventions

Placebo

Placebo Comparator

Placebo

Intervention: Placebo (Drug)

Serotonin agonist 13ug

Experimental

13ug of serotonin agonist

Intervention: Serotonin agonist - 13ug (Drug)

Serotonin agonist 26ug

Experimental

26ug of serotonin agonist

Intervention: Serotonin agonist - 26ug (Drug)

Outcomes

Primary Outcomes

DASS-21

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

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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