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- Check32 days agoChange DetectedThe value 'Show more Show more Revision: v2.9.0' has recently changed to 'Show less MedlinePlus Genetics related topics: Depression FDA Drug and Device Resources Show less Design Details Primary Purpose : Treatment Allocation : Randomized Interventional Model : Parallel Assignment Interventional Model Description: placebo-controlled, quadruple-blind, randomized, mono-centric Masking : Quadruple ( Participant Care Provider Investigator Outcomes Assessor ) Masking Description: quadruple-blind Arms and Interventions Participant Group/Arm Intervention/Treatment Placebo Comparator : Placebo one oral dose of 100% mannitol (placebo) Drug : Placebo oral capsule single dose of placebo (100% mannitol) Active Comparator : Psilocybin one oral dose of 0.215mg/kg psilocybin (verum) Drug : Psilocybine oral capsule single dose of psilocybin (0.215mg / kg body weight) Primary Outcome Measures Outcome Measure Measure Description Time Frame Montgomery Asberg Depression Scale observer-rated score for depression Day 32 Beck Depression Inventory self-rated score for depression Day 32 Secondary Outcome Measures Outcome Measure Measure Description Time Frame Changes in BOLD signal over time as measured by fMRI 3 times assessement of fMRI Day 17, 20, 32 5 Dimensions- Altered States of consciousness(5D-ASC) Assessment of subjective alterations in state of conciousness Day 18 Keywords Provided by University of Zurich Depression 5HT-2A Psilocybin clinical efficacy self emotion regulation placebo-controlled proof-of-concept Additional Relevant MeSH Terms Mood Disorders Mental Disorders Depressive Disorder Depressive Disorder, Major Hallucinogens Physiological Effects of Drugs Psychotropic Drugs Psilocybin Plan to Share Individual Participant Data (IPD)? Undecided Studies a U.S. FDA-Regulated Drug Product No Studies a U.S. FDA-Regulated Device Product No Product Manufactured in and Exported from the U.S. No Revision: v2.9.1SummaryDifference11%
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