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Mood Effects of Serotonin Agonists

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

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.

Condition or disease Intervention/treatment Phase
Healthy Drug: Lysergic Acid Diethylamide Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Mood Effects of Serotonin Agonists
Actual Study Start Date : May 1, 2018
Estimated Primary Completion Date : May 1, 2020
Estimated Study Completion Date : May 1, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Serotonin

Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo
Drug: Lysergic Acid Diethylamide
Drug will be administered in solution form.

Experimental: low dose MDMA
6.5ug dose of serotonin agonist
Drug: Lysergic Acid Diethylamide
Drug will be administered in solution form.

Experimental: medium dose
13ug dose of serotonin agonist
Drug: Lysergic Acid Diethylamide
Drug will be administered in solution form.

Experimental: high dose
26ug dose of serotonin agonist
Drug: Lysergic Acid Diethylamide
Drug will be administered in solution form.




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
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): NCT03790358


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   
Contact: Anya Bershad       abershad@uchicago.edu   
University of Chicago Recruiting
Chicago, Illinois, United States, 60637
Contact: Matthew Bona    773-702-3560    mbona@yoda.bsd.uchicago.edu   
Contact: Anya Bershad    773-702-7611    abershad@uchicago.edu   
Sponsors and Collaborators
University of Chicago
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT03790358    
Other Study ID Numbers: 15-1311
First Posted: December 31, 2018    Key Record Dates
Last Update Posted: December 31, 2018
Last Verified: December 2018
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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Lysergic Acid Diethylamide
Hallucinogens
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Receptor Agonists