Mood Effects of Serotonin Agonists
1 other identifier
interventional
80
1 country
2
Brief Summary
The purpose of this study is to determine the effects of very low doses of serotonergic agonists on depressed mood in human volunteers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 healthy
Started May 2018
Longer than P75 for phase_1 healthy
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2018
CompletedFirst Submitted
Initial submission to the registry
December 21, 2018
CompletedFirst Posted
Study publicly available on registry
December 31, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 27, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
January 27, 2023
CompletedJanuary 24, 2024
January 1, 2024
4.7 years
December 21, 2018
January 23, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Profile of Mood States (POMS)
The POMS measures individuals' mood states. This is a validated scale to measure positive and negative mood states. The POMS contains 30 items and assesses six identified mood factors: Tension-Anxiety, Depression-Ejection, Anger- Hostility, Vigor-Activity, Fatigue-Inertia, and Confusion-Bewilderment. Scoring of the instrument provides a global score of 0 to 120 or individual domain scores. Lower scores indicate better mood state. The POMS brief form is a simple self-rating instrument.
End of study (Baseline - time 0 and approximately 8 weeks later)
Study Arms (4)
Placebo
PLACEBO COMPARATORPlacebo
low dose MDMA
EXPERIMENTAL6.5ug dose of serotonin agonist
medium dose
EXPERIMENTAL13ug dose of serotonin agonist
high dose
EXPERIMENTAL26ug dose of serotonin agonist
Interventions
Drug will be administered in solution form.
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Matthew Bona
Chicago, Illinois, 60637, United States
University of Chicago
Chicago, Illinois, 60637, United States
Related Publications (2)
Bershad AK, Preller KH, Lee R, Keedy S, Wren-Jarvis J, Bremmer MP, de Wit H. Preliminary Report on the Effects of a Low Dose of LSD on Resting-State Amygdala Functional Connectivity. Biol Psychiatry Cogn Neurosci Neuroimaging. 2020 Apr;5(4):461-467. doi: 10.1016/j.bpsc.2019.12.007. Epub 2019 Dec 20.
PMID: 32033922DERIVEDBershad AK, Schepers ST, Bremmer MP, Lee R, de Wit H. Acute Subjective and Behavioral Effects of Microdoses of Lysergic Acid Diethylamide in Healthy Human Volunteers. Biol Psychiatry. 2019 Nov 15;86(10):792-800. doi: 10.1016/j.biopsych.2019.05.019. Epub 2019 Jun 3.
PMID: 31331617DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 21, 2018
First Posted
December 31, 2018
Study Start
May 1, 2018
Primary Completion
January 27, 2023
Study Completion
January 27, 2023
Last Updated
January 24, 2024
Record last verified: 2024-01
Data Sharing
- IPD Sharing
- Will not share