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
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 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 groupsSponsors and collaborators
NYU Langone Health
Lead sponsor
National Institute of Mental Health (NIMH)
Collaborator
Source ClinicalTrials.gov