Psilocybin With Pimavanserin Compared to Psilocybin Alone for the Treatment of Major Depressive Disorder

Part of paid clinical trials in New York, New York.

Sponsor
Icahn School of Medicine at Mount Sinai
Study ID
NCT06592833
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
21 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Psilocybin — DRUG
    Psilocybin, 25mg, given once orally.
  • Pimavanserin — DRUG
    Pimavanserin, 34mg, given once orally
  • Placebo — DRUG
    Matching placebo.

Study Details

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.

Key Dates

Start date
Feb 25, 2025
Status verified
May 2025
Primary completion
Mar 1, 2028
Completion
Mar 1, 2028

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Psilocybin + Pimavanserin
    single dose Psilocybin and single dose Pimavanserin
  • Placebo Comparator: Psilocybin + Placebo
    single dose Psilocybin and single dose Placebo

Primary Outcome Measure

Mystical Experience Questionnaire (MEQ-30) Score [ Time Frame: 6 hours post-treatment ]

Central Contacts

  • Depression and Anxiety Center Icahn School of Medicine at Mount Sinai
    (212) 241-6539
    [email protected]

Locations (1)

FacilityCityStateZIPSite coordinators
Icahn School of Medicine at Mount Sinai, Center for Psychedelic Therapy ResearchNew YorkNew York10025
Depression and Anxiety Center
[email protected]
212-241-6539
James Murrough (PRINCIPAL_INVESTIGATOR)

Find similar trials in New York, NY

By condition
Depression
By specialty
PsychiatryMental healthBehavioral health
By research site
Icahn School of Medicine at Mount Sinai, Center for Psychedelic Therapy Research· New York, NY

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