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Psilocybin as a Novel Therapy for Residual Anhedonia

Not Yet RecruitingPhase 1

Sponsor: NYU Langone Health

Conditions: Anhedonia, Emotional Blunting

Interventions: Psilocybin, Placebo

Countries: United States

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).

Eligibility overview

Sex: ALL

Age: 18 Years to 65 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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.

Locations (1)

New York, New York, United States