MedPath

Mood Effects of Serotonin Agonists

Phase 1
Completed
Conditions
Healthy
Interventions
Registration Number
NCT03790358
Lead Sponsor
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
80
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Arm && Interventions
GroupInterventionDescription
high doseLysergic Acid Diethylamide26ug dose of serotonin agonist
PlaceboLysergic Acid DiethylamidePlacebo
low dose MDMALysergic Acid Diethylamide6.5ug dose of serotonin agonist
medium doseLysergic Acid Diethylamide13ug dose of serotonin agonist
Primary Outcome Measures
NameTimeMethod
Change From Baseline in Profile of Mood States (POMS)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.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (2)

Matthew Bona

🇺🇸

Chicago, Illinois, United States

University of Chicago

🇺🇸

Chicago, Illinois, United States

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