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Trial record 4 of 4 for:    Lysergic Acid Diethylamide | First posted from 07/30/2018 to 03/21/2020

Mood Effects of Serotonin Agonists Extended (MESA-E)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03934710
Recruitment Status : Recruiting
First Posted : May 2, 2019
Last Update Posted : May 2, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Healthy Drug: Placebo Drug: Serotonin agonist Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Randomized
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Mood Effects of Serotonin Agonists Extended
Actual Study Start Date : April 20, 2019
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Serotonin

Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo
Drug: Placebo
Drug will be administered in solution form

Experimental: Serotonin agonist
13ug of serotonin agonist
Drug: Serotonin agonist
13ug lysergic acid diethylamide




Primary Outcome Measures :
  1. Profile of Mood States [ Time Frame: Baseline-two weeks after completion of the sessions. ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03934710


Contacts
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Contact: Matthew Bona 773-702-3560 mbona@yoda.bsd.uchicago.edu

Locations
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United States, Illinois
Matthew Bona Recruiting
Chicago, Illinois, United States, 60637
Contact: Matthew Bona    773-702-3560    mbona@yoda.bsd.uchicago.edu   
Sponsors and Collaborators
University of Chicago

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Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT03934710    
Other Study ID Numbers: IRB18-1183
First Posted: May 2, 2019    Key Record Dates
Last Update Posted: May 2, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Serotonin
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs