Mood Effects of Serotonin Agonists Extended

NCT03934710 | Completed Phase 1 Results DMC FDA Drug

• 2 other identifiers: IRB18-11835R01DA002812
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• 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.

  End of session 5, approximately 2 weeks from baseline

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Serotonin agonist 13ug

EXPERIMENTAL

13ug of serotonin agonist

Drug: Serotonin agonist - 13ug

Serotonin agonist 26ug

EXPERIMENTAL

26ug of serotonin agonist

Drug: Serotonin agonist - 26ug

Interventions

Placebo DRUG

Drug will be administered in solution form

Placebo

Serotonin agonist - 13ug DRUG

13ug lysergic acid diethylamide

Also known as: LSD

Serotonin agonist 13ug

Serotonin agonist - 26ug DRUG

26ug lysergic acid diethylamide

Also known as: LSD

Serotonin agonist 26ug

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Chicago: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Matthew Bona

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Interventions

Serotonin Receptor Agonists; Lysergic Acid Diethylamide

Intervention Hierarchy (Ancestors)

Serotonin Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Physiological Effects of Drugs; Lysergic Acid; Ergolines; Ergot Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Dr. Harriet de Wit
• Organization: University of Chicago

dewitlab@yoda.bsd.uchicago.edu

7737023560

Study Officials

• Harriet de Wit

  University of Chicago

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized

Study Record Dates

• First Submitted: April 29, 2019
• First Posted: May 2, 2019
• Study Start: April 20, 2019
• Primary Completion: June 7, 2021
• Study Completion: June 7, 2021
• Last Updated: November 29, 2023
• Results First Posted: November 29, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)