Psilocybin for Depressive Disorders: adverse events

ClinicalTrials.gov adverse events: Headache 33/50 (66%) in Psilocybin.

25 mg Psilocybin N=160 | 5 mg Psilocybin N=72 | 100 mg Nicotinamide N=48; IES. Back pain 3 (2%) 3 (4%) 3 (6%) Any serious adverse event 1 (1%) 0 (0%) 0 (0%) Dosing Days +1 until +7 Any adverse event 86 (54%) 32 (44%) 14 (29%) Any severe adverse event 6 (4%) 1 (1%) 2 (4%) Adverse events occurring in ≥ 5% of participants in any group Headache 32 (20%) 10 (14%) 3 (6%) Asthenia/Fatigue 13 (8%) 2 (3%) 0 (0%) Abnormal dreams 10 (6%) 3 (4%) 0 (0%) Anxiety 6 (4%) 0 (0%) 1 (2%) Panic attack 7 (4%) 0 (0%)

25 mg Psilocybin N=160 | 5 mg Psilocybin N=72 | 100 mg Nicotinamide N=48; (2%) Any serious adverse event 1 (1%) 0 (0%) 0 (0%) Dosing Days +8 (until +42 or next IMP administration) Any adverse event 102 (64%) 51 (71%) 33 (69%) Any severe adverse event 5 (3%) 3 (4%) 3 (6%) Adverse events occurring in ≥ 5% of participants in any group Headache 28 (18%) 21 (29%) 11 (23%) Depression 8 (5%) 3 (4%) 4 (8%) Covid-19 8 (5%) 1 (1%) 4 (8%) Nausea 6 (4%) 9 (13%) 1 (2%) Nasopharyngitis 7 (4%) 0 (0%) 5 (10%) B

25 mg Psilocybin N=160 | 5 mg Psilocybin N=72 | 100 mg Nicotinamide N=48; (2%) Any serious adverse event 1 (1%) 0 (0%) 0 (0%) Dosing Days +8 (until +42 or next IMP administration) Any adverse event 102 (64%) 51 (71%) 33 (69%) Any severe adverse event 5 (3%) 3 (4%) 3 (6%) Adverse events occurring in ≥ 5% of participants in any group Headache 28 (18%) 21 (29%) 11 (23%) Depression 8 (5%) 3 (4%) 4 (8%) Covid-19 8 (5%) 1 (1%) 4 (8%) Nausea 6 (4%) 9 (13%) 1 (2%) Nasopharyngitis 7 (4%) 0 (0%) 5 (10%) B

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

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

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

ClinicalTrials.gov adverse events: Nausea 10/14 (71.4%) in Ayahuasca.

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.

tolerated and no serious or unexpected AEs were reported. The AEs903 noted were transient anxiety (12/12 patients, 100%) during psilocybin onset, transient904 confusion or thought disorder (9/12 patients, 75%), mild t

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).

25 mg Psilocybin N=160 | 5 mg Psilocybin N=72 | 100 mg Nicotinamide N=48; g Psilocybin (N = 72) 100 mg Nicotinamide (N = 48) Dosing Days after IMP administration Any severe adverse event 44 (28%) 3 (4%) 4 (8%) Affect alteration/lability 11 (7%) 2 (3%) 2 (4%) Emotional distress 1 (1%) 0 (0%) 0 (0%) Dissociation 11 (7%) 0 (0%) 0 (0%) Anxiety 11 (7%) 0 (0%) 0 (0%) Panic attack 1 (1%) 0 (0%) 0 (0%) Vivid imagination 9 (6%) 0 (0%) 0 (0%) Hypertension 4 (3%) 0 (0%) 0 (0%) Hypertensive crisis 1 (1%) 0

25 mg Psilocybin N=160 | 5 mg Psilocybin N=72 | 100 mg Nicotinamide N=48; ious adverse event 1 (1%) 0 (0%) 0 (0%) Dosing Days +1 until +7 Any adverse event 86 (54%) 32 (44%) 14 (29%) Any severe adverse event 6 (4%) 1 (1%) 2 (4%) Adverse events occurring in ≥ 5% of participants in any group Headache 32 (20%) 10 (14%) 3 (6%) Asthenia/Fatigue 13 (8%) 2 (3%) 0 (0%) Abnormal dreams 10 (6%) 3 (4%) 0 (0%) Anxiety 6 (4%) 0 (0%) 1 (2%) Panic attack 7 (4%) 0 (0%) 1 (2%) Any serious adverse event 1 (1%) 0

ClinicalTrials.gov adverse events: Fatigue 6/22 (27.3%) in COMP360 Psilocybin.

ClinicalTrials.gov adverse events: Fatigue 6/24 (25%) in Ketamine+Education.

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

25 mg Psilocybin N=160 | 5 mg Psilocybin N=72 | 100 mg Nicotinamide N=48; OF THE CC-BY-NC-ND LICENSE, WHICH DOES NOT PERMIT ALTERATION OR COMMERCIAL USE, INCLUDING THOSE FOR TEXT AND DATA MINING, AI TRAINING, AND SIMILAR TECHNOLOGIES. Abdominal pain 7 (4%) 4 (6%) 2 (4%) Anxiety 5 (3%) 3 (4%) 1 (2%) Panic attack 2 (1%) 2 (3%) 2 (4%) Insomnia 4 (3%) 1 (1%) 5 (10%) Diarrhoea 5 (3%) 6 (8%) 3 (6%) Abdominal discomfort 2 (1%) 0 (0%) 3 (6%) Any serious adverse event 2 (1%) 0 (0%) 0 (0%) Footnotes: Adve

25 mg Psilocybin N=160 | 5 mg Psilocybin N=72 | 100 mg Nicotinamide N=48; OF THE CC-BY-NC-ND LICENSE, WHICH DOES NOT PERMIT ALTERATION OR COMMERCIAL USE, INCLUDING THOSE FOR TEXT AND DATA MINING, AI TRAINING, AND SIMILAR TECHNOLOGIES. Abdominal pain 7 (4%) 4 (6%) 2 (4%) Anxiety 5 (3%) 3 (4%) 1 (2%) Panic attack 2 (1%) 2 (3%) 2 (4%) Insomnia 4 (3%) 1 (1%) 5 (10%) Diarrhoea 5 (3%) 6 (8%) 3 (6%) Abdominal discomfort 2 (1%) 0 (0%) 3 (6%) Any serious adverse event 2 (1%) 0 (0%) 0 (0%) Footnotes: Adve

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

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

25 mg Psilocybin N=160 | 5 mg Psilocybin N=72 | 100 mg Nicotinamide N=48; 2026 MERTENS LJ ET AL. JAMA PSYCHIATRY. THIS IS AN OPEN ACCESS ARTICLE DISTRIBUTED UNDER THE TERMS OF THE CC-BY-NC-ND LICENSE, WHICH DOES NOT PERMIT ALTERATION OR COMMERCIAL USE, INCLUDING THOSE FOR TEXT AND DATA MINING, AI TRAINING, AND SIMILAR TECHNOLOGIES. Abdominal pain 7 (4%) 4 (6%) 2 (4%) Anxiety 5 (3%) 3 (4%) 1 (2%) Panic attack 2 (1%) 2 (3%) 2 (4%) Insomnia 4 (3%) 1 (1%) 5 (10%) Diarrhoea 5 (3%) 6 (8%) 3 (6%) Abdom

25 mg Psilocybin N=160 | 5 mg Psilocybin N=72 | 100 mg Nicotinamide N=48; 2026 MERTENS LJ ET AL. JAMA PSYCHIATRY. THIS IS AN OPEN ACCESS ARTICLE DISTRIBUTED UNDER THE TERMS OF THE CC-BY-NC-ND LICENSE, WHICH DOES NOT PERMIT ALTERATION OR COMMERCIAL USE, INCLUDING THOSE FOR TEXT AND DATA MINING, AI TRAINING, AND SIMILAR TECHNOLOGIES. Abdominal pain 7 (4%) 4 (6%) 2 (4%) Anxiety 5 (3%) 3 (4%) 1 (2%) Panic attack 2 (1%) 2 (3%) 2 (4%) Insomnia 4 (3%) 1 (1%) 5 (10%) Diarrhoea 5 (3%) 6 (8%) 3 (6%) Abdom

25 mg Psilocybin N=160 | 5 mg Psilocybin N=72 | 100 mg Nicotinamide N=48; R COMMERCIAL USE, INCLUDING THOSE FOR TEXT AND DATA MINING, AI TRAINING, AND SIMILAR TECHNOLOGIES. Abdominal pain 7 (4%) 4 (6%) 2 (4%) Anxiety 5 (3%) 3 (4%) 1 (2%) Panic attack 2 (1%) 2 (3%) 2 (4%) Insomnia 4 (3%) 1 (1%) 5 (10%) Diarrhoea 5 (3%) 6 (8%) 3 (6%) Abdominal discomfort 2 (1%) 0 (0%) 3 (6%) Any serious adverse event 2 (1%) 0 (0%) 0 (0%) Footnotes: Adverse events (AEs) are reported as treatment-emergent AEs starti

25 mg Psilocybin N=160 | 5 mg Psilocybin N=72 | 100 mg Nicotinamide N=48; 2026 MERTENS LJ ET AL. JAMA PSYCHIATRY. THIS IS AN OPEN ACCESS ARTICLE DISTRIBUTED UNDER THE TERMS OF THE CC-BY-NC-ND LICENSE, WHICH DOES NOT PERMIT ALTERATION OR COMMERCIAL USE, INCLUDING THOSE FOR TEXT AND DATA MINING, AI TRAINING, AND SIMILAR TECHNOLOGIES. Abdominal pain 7 (4%) 4 (6%) 2 (4%) Anxiety 5 (3%) 3 (4%) 1 (2%) Panic attack 2 (1%) 2 (3%) 2 (4%) Insomnia 4 (3%) 1 (1%) 5 (10%) Diarrhoea 5 (3%) 6 (8%) 3 (6%) Abdom