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Psilocybin + Pimavanserin for Depression

Phase 2
Waitlist Available
Led By Rachel Fremont
Research Sponsored by Icahn School of Medicine at Mount Sinai
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Current primary diagnosis of Unipolar Major Depressive Disorder (MDD) without psychotic features using DSM-5 criteria
Current diagnosis of Major Depressive Episode (MDE)
Must not have
History of mania
Hypersensitivity to either psilocybin or pimavanserin
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7 days after dosing

Summary

This trial will test the effects of pimavanserin and psilocybin on individuals with Major Depressive Disorder. Participants will receive a single dose of either the study drug or a placebo,

Who is the study for?
This trial is for individuals with Major Depressive Disorder (MDD). Specific eligibility criteria are not provided, but typically participants must meet diagnostic criteria for MDD and may need to be within a certain age range or health status.
What is being tested?
The study is testing the effects of a single dose of psilocybin in combination with either pimavanserin or a placebo. Participants will be assigned to one of these treatments randomly and monitored over five weeks post-dosing.
What are the potential side effects?
While specific side effects are not listed, common ones associated with psilocybin include nausea, headache, increased heart rate, blood pressure changes, and psychological effects like anxiety or altered perception.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with major depression without psychosis.
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I am currently diagnosed with a major depressive episode.
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I am between 21 and 80 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a history of mania.
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I am allergic to psilocybin or pimavanserin.
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I have a history of irregular heartbeats or take medication for it.
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I am taking medication that can affect my heart's rhythm.
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I have or someone in my family has a history of long QT syndrome.
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My blood pressure and heart rate are within normal ranges.
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I have been diagnosed with severe depression.
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I do not have any severe or unstable illnesses, including kidney or liver problems.
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My family has a history of sudden or unexplained deaths.
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A close family member has had psychosis or schizophrenia.
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A close family member has bipolar disorder.
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I have a disability that makes it hard for me to complete health assessments.
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I am not taking any medications that could interfere with the study treatment.
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I have heart or blood pressure conditions that could worsen with increased heart rate or blood pressure.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7 days after dosing
This trial's timeline: 3 weeks for screening, Varies for treatment, and 7 days after dosing for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Mystical Experience Questionnaire (MEQ-30) Score
Secondary study objectives
Montgomery-Åsberg Depression Rating Scale (MADRS) Score

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Psilocybin + PimavanserinActive Control2 Interventions
single dose Psilocybin and single dose Pimavanserin
Group II: Psilocybin + PlaceboPlacebo Group2 Interventions
single dose Psilocybin and single dose Placebo

Find a Location

Who is running the clinical trial?

Icahn School of Medicine at Mount SinaiLead Sponsor
904 Previous Clinical Trials
541,898 Total Patients Enrolled
38 Trials studying Depression
6,002 Patients Enrolled for Depression
Rachel FremontPrincipal InvestigatorIcahn School of Medicine at Mount Sinai
James MurroughPrincipal InvestigatorIcahn School of Medicine at Mount Sinai
~40 spots leftby Sep 2027
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