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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 2026-08-20

No results posted yet for this study

Summary

This study is for adults with major depressive disorder (depression) who are currently taking an SSRI or SNRI antidepressant but continue to experience anhedonia (reduced interest or pleasure) and emotional blunting.

The study will test whether a single 25 mg dose of psilocybin, compared with placebo, can improve these symptoms and improve the function of brain circuits involved in reward and motivation. Researchers will measure changes using brain imaging (fMRI) and clinical questionnaires, including the Dimensional Anhedonia Rating Scale (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
2026-09-30
Primary Completion
2030-08-01
Completion
2030-09-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

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