Psilocybin as a Novel Therapy for Residual Anhedonia
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorNYU Langone Health
About this trial
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).
Eligibility criteria
Qualifiers
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
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Psilocybin
- Placebo
Treatment groups
90 Participants
are divided into 2 treatment groupsLocations
1NYU Langone Health10016, New YorkNew York, United States
Sponsors and collaborators
NYU Langone Health
Lead sponsor
National Institute of Mental Health (NIMH)
Collaborator
Source ClinicalTrials.gov