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Not yet recruiting NCT07607938

Psilocybin as a Novel Therapy for Residual Anhedonia

Phase I Interventional Anhedonia Emotional Blunting

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Psilocybin, Placebo.
Who it may be relevant to
Registry conditions: Anhedonia, Emotional Blunting. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Targeting Reward Circuits: Psilocybin as a Novel Therapy for Residual Anhedonia

Overview

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).

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.

Primary outcome measures

  • Change in Dimensional Anhedonia Rating Scale (DARS) Score [Time frame: Baseline (Week -3), End of Study (Week 8)]
  • Change in Fronto-Striatal Connectivity (pgACC-NAcc FC) [Time frame: Baseline (Week -3), End of Study (Week 8)]
Secondary outcome measures (3)
  • Change in Motivation and Pleasure Scale - Self-Report (MAP-SR) Score [Time frame: Baseline (Week -3), End of Study (Week 8)]
  • Change in Experiential Avoidance (BEAQ) Score [Time frame: Baseline (Week -3), End of Study (Week 8)]
  • Change in Montgomery-Asberg Depression Scale (MADRS) Score [Time frame: Baseline (Week -3), End of Study (Week 8)]

Eligibility criteria

Inclusion criteria

  • Age between 18 and 65 years
  • Able to provide voluntary signed and dated informed consent.
  • Females of childbearing potential (FOCBP) must agree to practice an effective means of birth control throughout the duration of the trial
  • Males who have FOCBPs as partners must agree to practice an effective means of birth control throughout the duration of the trial
  • State willingness to comply and be available for all study requirements, including psychological, cognitive, imaging and procedural evaluations for the duration of the study
  • Meet DSM-5 criteria for major depressive disorder (MDD)
  • Screening Dimensional Anhedonia Rating Scale (DARS) total score of < 28.5 points
  • Have an identified support person
  • Agree to refrain from taking all non-prescription medications and supplements (nutritional and herbal) for at least 1 week prior to the IP administration session unless approved by the Investigator.

Exclusion criteria

  • Inability to speak and understand English sufficiently to complete informed consent and study procedures.
  • Inability to provide informed consent.
  • Women who are pregnant or who intend to become pregnant or nurse during the study duration.
  • Prior exposure to classic psychedelics (i.e., psilocybin, LSD, ayahuasca, and/or mescaline) within the past 1 year.
  • Current or previous psychiatric conditions that meet DSM-5 criteria for psychotic disorders (i.e., schizophrenia, schizoaffective disorder, MDD with psychosis), bipolar 1 or 2 disorder, or current diagnosis of active substance use disorder.
  • Have active suicidal ideation with intent, based on Columbia-Suicide Severity Rating Scale (C-SSRS assessment (severity score > 3) at the Screening visit, confirmed by the Investigator.
  • Have made a medically significant suicide attempt (i.e., one that had a significant possibility of causing death or permanent harm in the absence of intervention) within the past 12 months, based on Screening C-SSRS assessment and confirmation by the Investigator.
  • Immediate family history (i.e., parents, full siblings, or half siblings) with known or suspected psychotic disorder.
  • Presence of medical conditions that may confound results of imaging study or that are contraindications to or psilocybin exposure (i.e., neurological, renal, hypertension, metabolic or cardiovascular disease or pregnancy);
  • Presence of contraindications to MRI scanning (implantable devices, bone hardware, various IUD).
  • Participants who received electroconvulsive therapy (ECT), trans magnetic cranial stimulation (TMS), and/or ketamine in the past 90 days.
  • Has any other physical or psychological symptom, medication, or other relevant finding prior to randomization that, based on the clinical judgment of trial personnel, would make a participant unsuitable for the trial.
  • Are unable or unwilling to discontinue taking any protocol-prohibited medications and supplements.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • NYU Langone Health — New York

Identifiers

NCT: NCT07607938 · 26-00063 · R01MH142698

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗