Psilocybin as a Novel Therapy for Residual Anhedonia
Trial statusRecruiting
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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Psilocybin
DrugOne-time dose of psilocybin 25 mg, oral, in capsule form.
Placebo
DrugOne-time dose of placebo (25 mg of inert filler), oral, in capsule form.
Treatment groups
90 Participants
are divided into 2 treatment groupsGroup A: PsilocybinExperimental treatment 1 intervention
Group B: ControlPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change 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)2
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)Secondary outcomes
1
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)2
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)3
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)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
NYU Langone Health
Lead sponsor
National Institute of Mental Health (NIMH)
Collaborator
Source ClinicalTrials.gov