The purpose of this research is to study the safety and effects of single-dose psilocybin 25mg versus an active dummy treatment (placebo) (single dose niacin 100mg) in the treatment of anxiety, depression, and existential distress (i.e., loss of meaning and hope; fear of death) in advanced cancer (i.e., stage 3 or 4). Study medications will be administered in conjunction with brief psychotherapy that is designed to treat anxiety, depression and existential distress in advanced cancer.
Official registry: https://clinicaltrials.gov/study/NCT05398484 · NYU Langone Health · enrollment listed as 200
Phase 2/3: earlier tests looked promising enough to expand. This stage asks, in a larger group, whether the treatment really works and is safe enough to seek approval.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
If you join, the listed intervention(s) are Psilocybin 25 mgs, Niacin 100mg, or Psychotherapy. The registry lists allocation as randomized. The purpose of this research is to study the safety and effects of single-dose psilocybin 25mg versus an active dummy treatment (placebo) (single dose niacin 100mg) in the treatment of anxiety, depression, and existential distress (i.e., loss of meaning and hope; fear of death) in advanced cancer (i.e., stage 3 or 4).
They plan to enroll about 200 people at 2 sites. Taking part typically means taking a study drug (or dummy pill), following a program (exercise, therapy, diet, or an app) plus check-ins.
A Phase 2b, Randomized, Double-blind, Placebo-controlled, Multi-center Study of the Effects of Psilocybin-assisted Psychotherapy on Psychiatric and Existential Distress in Advanced Cancer
Interventions: Psilocybin 25 mgs, Niacin 100mg, Psychotherapy
Primary outcome (registry wording): Change in Structured Interview Guide for the Hamilton Anxiety Scale (HAM-A): SIGH-A Score
Tallulah Laska
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
Study Description: This study examines relations between neurocognitive and clinical features of pediatric anxiety disorders. The study uses neuro-cognitive tasks, functional magnetic resonance imaging (fMRI), as well as magneto- and electro-encephalography (M/EEG).
NCT00018057 · Official ClinicalTrials.gov record · National Institute of Mental Health (NIMH)
Background: There are no good treatments for people considering suicide. Researchers want to study suicide with questions, blood tests, brain imaging, and sleep studies.
NCT02543983 · Official ClinicalTrials.gov record · National Institute of Mental Health (NIMH)
The specific aims of the study are: Primary: To determine the presence and regional distribution of microglial activation, as assessed by Fluorine-18 (18F) labeled "Peripheral Benzodiazepine Receptor 06" (PBR06) -PET, in subjects with active Relapsing Remitting Multiple Sclerosis (RRMS), Secondary Progressive Multiple Sclerosis (SPMS), and Alzheimer's Disease (AD) as compared to healthy controls Secondary: 1. To assess the relationship between microglial activation and clinical variables including disease severity and comorbidities (such as pain, fatigue and/or depression), as well as clinical MRI findings (such as lesions and atrophy) 2.
NCT02649985 · Official ClinicalTrials.gov record · Brigham and Women's Hospital
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
Phase 2 / Phase 3. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary