Mood Effects of Serotonin Agonists

• ClinicalTrials.gov Identifier: NCT03790358
• Recruitment Status: Unknown
• First Posted: December 31, 2018
• Last Update Posted: December 31, 2018
• Sponsor: University of Chicago
• Information provided by (Responsible Party): University of Chicago

Tracking Information

• First Submitted Date: December 21, 2018
• First Posted Date: December 31, 2018
• Last Update Posted Date: December 31, 2018
• Actual Study Start Date: May 1, 2018
• Estimated Primary Completion Date: May 1, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: December 28, 2018)

Change From Baseline in Profile of Mood States (POMS) [ Time Frame: End of study (Baseline - time 0 and approximately 8 weeks later) ]

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.

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Mood Effects of Serotonin Agonists
• Official Title: Mood Effects of Serotonin Agonists
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Triple (Participant, Care Provider, Outcomes Assessor); Primary Purpose: Basic Science
• Condition: Healthy

Intervention

Drug: Lysergic Acid Diethylamide

Drug will be administered in solution form.

Study Arms

• Placebo Comparator: Placebo
  Placebo
  Intervention: Drug: Lysergic Acid Diethylamide
• Experimental: low dose MDMA
  6.5ug dose of serotonin agonist
  Intervention: Drug: Lysergic Acid Diethylamide
• Experimental: medium dose
  13ug dose of serotonin agonist
  Intervention: Drug: Lysergic Acid Diethylamide
• Experimental: high dose
  26ug dose of serotonin agonist
  Intervention: Drug: Lysergic Acid Diethylamide

Publications *

• 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.
• Bershad 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.

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: December 28, 2018): 40
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: May 1, 2020
• Estimated Primary Completion Date: May 1, 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All
• Gender Based Eligibility: Yes

• Ages: 18 Years to 35 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03790358
• Other Study ID Numbers: 15-1311
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: University of Chicago
• Study Sponsor: University of Chicago
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: University of Chicago
• Verification Date: December 2018