Actively Recruiting
Psilocybin With Pimavanserin Compared to Psilocybin Alone for the Treatment of Major Depressive Disorder
Led by Icahn School of Medicine at Mount Sinai · Updated on 2025-05-14
60
Participants Needed
1
Research Sites
157 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is an interventional, parallel arm assignment treatment study in individuals with Major Depressive Disorder (MDD). Each individual will be treated with a single dose of pimavanserin or placebo plus a single dose of psilocybin. Evaluations will be taken before dosing and following dosing at several timepoints up to 5 weeks post-dosing.
CONDITIONS
Official Title
Psilocybin With Pimavanserin Compared to Psilocybin Alone for the Treatment of Major Depressive Disorder
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 21 to 80 years, any gender
- Current primary diagnosis of Unipolar Major Depressive Disorder without psychotic features by DSM-5 criteria
- 24-item Hamilton Rating Scale for Depression score of 16 or higher
- Current diagnosis of Major Depressive Episode
- Able to give informed consent and follow study procedures
- Using or agreeing to use highly effective contraception during the study if of childbearing potential
- Discontinued serotonergic drugs for at least 2 weeks or 5 half-lives before psilocybin dosing
You will not qualify if you...
- Substance use disorder in the last 6 months (except tobacco)
- Psychiatric hospitalization within the last 6 months or current hospitalization
- Use of psychedelics in the past 12 months
- Non-medical use of ketamine in the past 12 months
- Negative reaction to prior psychedelics
- Past or current psychotic disorder, mania, or bipolar disorder
- Severe depression with Clinical Global Impressions score 5 or higher at baseline
- Significant suicidal thoughts or behavior recently
- Acute, severe, or unstable medical illness
- Weight over 300 lbs or body size incompatible with MRI scanner
- Conditions unsafe for MRI participation
- Physical or intellectual disability affecting assessments
- Pregnancy or breastfeeding
- Abnormal lab tests including liver or kidney function
- Taking contraindicated medications such as antipsychotics or serotonergic antidepressants
- History of abnormal or prolonged QT interval or cardiac arrhythmias
- Family history of psychosis, bipolar disorder, or sudden cardiac death
- Cardiovascular conditions that increase risk for QT prolongation
- High blood pressure or heart rate above defined limits at screening and dosing
- Allergy to psilocybin or pimavanserin
- Psychiatric or other conditions preventing safe psilocybin exposure
- Positive urine drug test at screening
- Clinically significant ECG abnormalities
- Mini-Mental State Exam score below 25
- Brief Psychiatric Rating Scale score above 5
- Risk of falls
AI-Screening
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Trial Site Locations
Total: 1 location
1
Icahn School of Medicine at Mount Sinai, Center for Psychedelic Therapy Research
New York, New York, United States, 10025
Actively Recruiting
Research Team
D
Depression and Anxiety Center Icahn School of Medicine at Mount Sinai
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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