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).
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
RECRUITINGChange 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.
Time frame: Baseline (Week -3), End of Study (Week 8)
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