Psilocybin as a Novel Therapy for Residual Anhedonia

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

Sponsor
NYU Langone Health
Study ID
NCT07607938
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

  • Anhedonia
  • Emotional Blunting

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Psilocybin — DRUG
    One-time dose of psilocybin 25 mg, oral, in capsule form.
  • Placebo — DRUG
    One-time dose of placebo (25 mg of inert filler), oral, in capsule form.

Study Details

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).

Key Dates

Start date
Jul 31, 2026
Status verified
May 2026
Primary completion
Aug 1, 2030
Completion
Sep 30, 2030

Study Design

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

Arms

  • Experimental: Psilocybin
    Participants will complete a total of six MRI sessions; two sessions prior to psilocybin administration day and four sessions after. On administration day, the psilocybin arm will receive psilocybin (25 mg single dose, under supervision).
  • Placebo Comparator: Control
    Participants will complete a total of six MRI sessions; two sessions prior to placebo administration day and four sessions after. The control arm will receive placebo on administration day.

Primary Outcome Measure

Change in Dimensional Anhedonia Rating Scale (DARS) Score [ Time Frame: Baseline (Week -3), End of Study (Week 8) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
NYU Langone HealthNew YorkNew York10016-

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By research site
NYU Langone Health· New York, NY

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