Mood Effects of Serotonin Agonists Extended

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Placebo; Drug: Serotonin agonist - 13ug; Drug: Serotonin agonist - 26ug

• Registration Number: NCT03934710
• Lead Sponsor: University of Chicago

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 Timeline

• Study Start: 2019-04-20
• Study First Submitted: 2019-04-29
• Study First Submitted QC: 2019-04-29
• Study First Posted: 2019-05-02
• Primary Completion: 2021-06-07
• Study Completion: 2021-06-07
• Results First Submitted: 2022-07-19
• Status Verified: 2023-11
• Results First Submitted QC: 2023-11-28
• Last Update Submitted: 2023-11-28
• Results First Posted: 2023-11-29
• Last Update Posted: 2023-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo
Serotonin agonist 13ug	Serotonin agonist - 13ug	13ug of serotonin agonist
Serotonin agonist 26ug	Serotonin agonist - 26ug	26ug of serotonin agonist

Primary Outcome Measures

Name	Time	Method
DASS-21	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.

Trial Locations

Locations (1)

Matthew Bona; 🇺🇸 Chicago, Illinois, United States