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Psilocybin as a Novel Therapy for Residual Anhedonia

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 65 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Researchers will measure changes using brain imaging (fMRI) and clinical questionnaires, including the Dimensional Anhedonia Rating Scale (DARS)."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study is for adults with depression who take an SSRI or SNRI antidepressant but still have little interest or pleasure and feel less emotion. It tests whether one 25 mg dose of psilocybin works better than a placebo, which has no active drug. Researchers will use brain scans and surveys to check symptoms and brain activity linked to reward and motivation.

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).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be 18 to 65 years old and meet the study’s rules for a diagnosis of major depression.
  • Be able to freely agree to join and sign and date the consent form.
  • Use effective birth control during the study if you can become pregnant or have a partner who can.
  • Be willing and available to complete all study visits, tests, and brain scans.
  • Score below 28.5 on the DARS survey, which measures interest and pleasure.
  • Have a support person.
  • Stop all over-the-counter medicines and nutrition or herbal supplements at least 1 week before the study dose, unless the study doctor approves them.

Who can't join

  • Cannot understand or speak enough English for study tasks, or cannot give informed consent.
  • Are pregnant, or plan to become pregnant or breastfeed during the study.
  • Used psilocybin, LSD, ayahuasca, or mescaline in the past year.
  • Have ever had bipolar disorder or a psychotic disorder, which can affect what seems real; have a current active substance use disorder; or have a parent, full sibling, or half sibling with a known or suspected psychotic disorder.
  • Have current thoughts of suicide with intent to act, as checked by the study team, or made a suicide attempt in the past year that could have caused death or lasting harm.
  • Have a health condition that could affect the brain scans or make psilocybin unsafe, or have a device, bone hardware, or certain IUDs that make MRI scans unsafe.
  • Received electroconvulsive therapy (ECT), brain stimulation called TMS, or ketamine in the past 90 days.
  • Cannot or will not stop medicines or supplements banned by the study, or have another symptom, medicine, or finding that the study team says makes the study unsuitable.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (1)

NY