one oral dose of 0.215mg/kg psilocybin (verum)

Depressive Disorder, Major

single dose of psilocybin (0.215mg / kg body weight)

Psilocybine oral capsule

Placebo oral capsule

Psychiatrische Universitätsklinik Zürich

Clinical, Neurocognitive, and Emotional Effects of Psilocybin in Depressed Patients - Proof of Concept

Phase II, Randomized, Double Blind, Placebo Controlled, Parallel Group, Single Center Study of Psilocybin Efficacy in Major Depression

Assessment of subjective alterations in state of conciousness

University of Zurich

Schweizerischer Nationalfonds

Healthy

Dose 1: 0.3 mg/kg (approximately 20mg/70kg) Dose 2: 0.45 mg/kg (approximately 30 mg/70 kg) Dose 3: 0.6 mg/kg (approximately 40 mg/70 kg)

Psilocybin

University of Wisconsin, School of Pharmacy

UW Psilocybin Pharmacokinetics Study

Pharmacokinetics of Psilocybin in Normal Adult Volunteers

Determine the AUC of psilocin in plasma following single doses of 0.3, 0.45, and 0.6 mg/lg psilocybin, the precursor to psilocin.

Quantitate any non-linearity of the plasma AUC of psilocybin and its active metabolite psilocin after escalation doses of psilocybin.

Use urine and plasma collections to quantitate the relative renal clearance of creatinine and psilocin to characterize the dependency of renal clearance of psilocin upon the glomerular filtration rate. Variation in renal function will arise from the range of ages in subjects; subjects are not selected or grouped based upon renal function.

The incidence and severity of expected and unexpected adverse events will be collected using the NCI Common Toxicity Criteria for Adverse Events (CTCAE) v4 during and in treatment follow-up.

University of Wisconsin, Madison

Psilocybin: Psilocybin is a serotonergic hallucinogen that will be administered once at a dose of 0.3mg/kg

Psilocybin First, Then Niacin

Niacin: Psilocybin and niacin will be administered in identically appearing opaque, size 0 gelatin capsules with approximately 180ml of water. The niacin dose will be 250mg

Niacin First, Then Psilocybin

Total

Age, Customized

Sex: Female, Male

Race (NIH/OMB)

Region of Enrollment

Hospital Anxiety and Depression Scale (HADS) used for measuring anxiety; Scored on a scale of 0-21 (higher score more anxiety)

Drug intervention
Psilocybin: Psilocybin is a serotonergic hallucinogen that will be administered once at a dose of 0.3mg/kg
Niacin: Psilocybin and niacin will be administered in identically appearing opaque, size 0 gelatin capsules with approximately 180ml of water. The niacin dose will be 250mg

Active control
Psilocybin: Psilocybin is a serotonergic hallucinogen that will be administered once at a dose of 0.3mg/kg
Niacin: Psilocybin and niacin will be administered in identically appearing opaque, size 0 gelatin capsules with approximately 180ml of water. The niacin dose will be 250mg

HADS Anxiety

STAI scores 20-80 (higher score more anxiety). Commonly classified as "no or low anxiety" (20-37), "moderate anxiety" (38-44), and "high anxiety" (45-80).

State-Trait Anxiety Inventory (STAI) State

STAI State

HADS Depression

STAI Trait

Hospital Anxiety and Depression Scale (HADS) used for measuring depression; Scored on a scale of 0-21 (higher score more depression)

Death Anxiety Scale

0-60 (higher score more death transcendence)

Death Transcendence Scale

Hopelessness

Demoralization Scale

4-20 (higher score improved quality of life domain)

QoL Physical Health Scale

QoL Psychological Scale

QoL Social Relationships Scale

QoL Environment Scale

Psilocybin and niacin will be administered in identically appearing opaque, size 0 gelatin capsules with approximately 180ml of water. The niacin dose will be 250mg.

Psilocybin and niacin will be administered in identically appearing opaque, size 0 gelatin capsules with approximately 180ml of water. The niacin dose will be 250mg

Overall Study

Stephen Ross, MD

Niacin

Cancer

Psilocybin is a serotonergic hallucinogen that will be administered once at a dose of 0.3mg/kg

dimethyltryptamine/kanser

Clinical, Neurocognitive, and Emotional Effects of Psilocybin in Depressed Patients - Proof of Concept

UW Psilocybin Pharmacokinetics Study

Psilocybin Cancer Anxiety Study

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