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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
90
One-time dose of psilocybin 25 mg, oral, in capsule form.
One-time dose of placebo (25 mg of inert filler), oral, in capsule form.
NYU Langone Health
New York, New York, United States
Change in Dimensional Anhedonia Rating Scale (DARS) Score
DARS is a 17-item, patient-reported instrument designed to measure "state" anhedonia (how a person is feeling right now). The total score is the sum of responses and ranges from 0-68; lower scores indicate more severe anhedonia.
Time frame: Baseline (Week -3), End of Study (Week 8)
Change in Fronto-Striatal Connectivity (pgACC-NAcc FC)
This outcome measures the change in functional connectivity (FC) between the pregenual anterior cingulate cortex (pgACC) and the nucleus accumbens (NAcc). PgACC-NAcc FC will be measured using fMRI sequencing. The standard deviation of FC is assumed to be 0.1.
Time frame: Baseline (Week -3), End of Study (Week 8)
Change in Motivation and Pleasure Scale - Self-Report (MAP-SR) Score
MAP-SR is an 15-item self-report assessment designed to measure the "experiential" negative symptoms of psychiatric disorders. Each item is rated on a scale from 0-4; the total score is the sum of responses and ranges from 0-60; lower scores indicate more severe psychiatric symptoms.
Time frame: Baseline (Week -3), End of Study (Week 8)
Change in Experiential Avoidance (BEAQ) Score
The Brief Measure of Experimental Avoidance Questionnaire (BEAQ) is a 15-item assessment of experiential avoidance. Each item is rated on a scale from 1-6; the total score is the sum of responses and ranges from 15 to 90. Higher scores indicate greater levels of experiential avoidance (and lower psychological flexibility).
Time frame: Baseline (Week -3), End of Study (Week 8)
Change in Montgomery-Asberg Depression Scale (MADRS) Score
The MADRS is a 10-item assessment of depression severity. Each item is rated on a scale from 0-6; the total score is the sum of responses and ranges from 0-60. Higher scores indicate greater severity of depression.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Baseline (Week -3), End of Study (Week 8)