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Psilocybin as a Novel Therapy for Residual Anhedonia

NCT07607938 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2026-05-27

No results posted yet for this study

Summary

The primary objective is to evaluate whether a single dose of psilocybin (25 mg), compared to placebo, can restore fronto-striatal reward circuit function and thereby improve anhedonia and emotional blunting in individuals with residual symptoms despite ongoing SSRI or SNRI treatment. This will be assessed using precision functional mapping (PFM), task-based fMRI, and clinical rating scales (DARS).

Conditions

  • Anhedonia
  • Emotional Blunting

Interventions

DRUG

Psilocybin

One-time dose of psilocybin 25 mg, oral, in capsule form.

DRUG

Placebo

One-time dose of placebo (25 mg of inert filler), oral, in capsule form.

Sponsors & Collaborators

  • National Institute of Mental Health (NIMH)

    collaborator NIH

  • NYU Langone Health

    lead OTHER

Principal Investigators

  • Joshua Siegel, MD, PhD · NYU Langone Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-31
Primary Completion
2030-08-01
Completion
2030-09-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07607938 on ClinicalTrials.gov