Psilocybin for Anxiety Disorders: adverse events

ClinicalTrials.gov adverse events: Nausea 24/50 (48%) in Psilocybin.

ClinicalTrials.gov adverse events: Nausea 10/48 (20.8%) in Psilocybin.

Consistent with our earlier report on the initial 12 patients from this trial, transient anxiety lasting for minutes (n = 15) and headaches lasting no more than 1-2 days (n = 8) were the most common side effects. Five reported transient nausea but there were no cases of vomiting.

ClinicalTrials.gov adverse events: Nausea 4/45 (8.9%) in Diphenhydramine.

Consistent with our earlier report on the initial 12 patients from this trial, transient anxiety lasting for minutes (n = 15) and headaches lasting no more than 1-2 days (n = 8) were the most common side effects. Five reported transient nausea but there were no cases of vomiting.

The most common adverse events were transient anxiety (mostly mild) during drug onset (n=12), transient confusion or thought disorder (n=9), mild and transient nausea (n=4), and transient headache (n=4; table).

ClinicalTrials.gov adverse events: Anxiety 7/48 (14.6%) in Psilocybin.

ClinicalTrials.gov adverse events: Anxiety 5/50 (10%) in Psilocybin.

ClinicalTrials.gov adverse events: Fatigue 5/50 (10%) in Psilocybin.

ClinicalTrials.gov adverse events: fatigue 5/12 (41.7%) in Psilocybin.

Part A) Preferred Term TSND-201 (150mg + 100mg) (N=14) n (%) At least one TEAE 11 (78.6) Headache 6 (42.9) Decreased appetite 4 (28.6) Non-cardiac chest pain 3 (21.4) Fatigue 3 (21.4) Bruxism 2 (14.3) Dizziness 2 (14.

ClinicalTrials.gov adverse events: Fatigue 1/54 (1.9%) in Niacin.

ClinicalTrials.gov adverse events: Insomnia 3/50 (6%) in Psilocybin.

ClinicalTrials.gov adverse events: Insomnia 3/48 (6.3%) in Psilocybin.

ClinicalTrials.gov adverse events: Insomnia 2/45 (4.4%) in Diphenhydramine.

ClinicalTrials.gov adverse events: Insomnia 1/54 (1.9%) in Niacin.

No serious adverse events occurred; mild adverse events included transient hypertension (n = 4), nausea (n = 3), and headache (n = 1).

Psilocybin 25 mg N=17 | Niacin 100 mg N=18; verse events – study medication 3 2 Related severe adverse events, study procedures 1 0 Dosing Any adverse event, No. 37 10 Headache, No. (%) 8 (47.1) 4 (22.2) Hallucination, No. (%) 5 (29.4) – Agitation, No. (%) 3 (17.6) – Anxiety, No. (%) 3 (17.6) 1 (5.6) * Hypertension, No. (%) 3 (17.6) – Nausea, No. (%) 2 (11.8) 1 (5.6) * Paresthesia, No. (%) 2 (11.8) 1 (5.6) * Serious adverse events, No. 0 0 Severe adverse events, No. 1 0 Day 15 Any adverse event,

The most common AEs were transient anxiety prior to administration and drug onset (n = 6), transient headache (n = 2) during onset and after resolution of drug effects, and transient hypertension (n = 2) before dose and during onset of effects (Table).

ClinicalTrials.gov adverse events: Blood pressure increased 1/48 (2.1%) in Psilocybin.