Mood Effects of Serotonin Agonists

NCT ID: NCT03790358

Last Updated: 2024-01-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-01

Study Completion Date

2023-01-27

Brief Summary

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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

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Placebo

Placebo

Group Type PLACEBO_COMPARATOR

Lysergic Acid Diethylamide

Intervention Type DRUG

Drug will be administered in solution form.

low dose MDMA

6.5ug dose of serotonin agonist

Group Type EXPERIMENTAL

Lysergic Acid Diethylamide

Intervention Type DRUG

Drug will be administered in solution form.

medium dose

13ug dose of serotonin agonist

Group Type EXPERIMENTAL

Lysergic Acid Diethylamide

Intervention Type DRUG

Drug will be administered in solution form.

high dose

26ug dose of serotonin agonist

Group Type EXPERIMENTAL

Lysergic Acid Diethylamide

Intervention Type DRUG

Drug will be administered in solution form.

Interventions

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Lysergic Acid Diethylamide

Drug will be administered in solution form.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Chicago

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Matthew Bona

Chicago, Illinois, United States

Site Status

University of Chicago

Chicago, Illinois, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 32033922 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31331617 (View on PubMed)

Other Identifiers

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15-1311

Identifier Type: -

Identifier Source: org_study_id

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