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

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).

Key Dates

First listed
May 27, 2026
Start date
Sep 30, 2026
Status verified
Aug 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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