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LSD

Trials registered: 40
Completed: 26
Posted safety data: 3
Participants analysed for safety: 266

Keyshare of the arm affected26/50 = affected / analysedSeriousflagged by the trial as life-threatening, or leading to hospitalisation, disability or deathn = analysed for safety (not enrolled)

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A Dose-Finding Study of MM120 (LSD D-Tartrate) for the Treatment of Anxiety Symptoms

NCT05407064Phase 2198 enrolledDefinium Therapeutics US, Inc.Results posted Mar 2025

Observation window: AE collection will occur from the time informed consent is given until Week 12 (or early discontinuation) and will be recorded at each visit.

Study summary · from ClinicalTrials.gov

This is a Phase 2, multi-center, randomized, double-blind, parallel-group, dose-finding study to assess the effect of 4 doses of MM120 (25, 50, 100 or 200 μg freebase-equivalent) for the treatment of anxiety symptoms in subjects diagnosed with generalized anxiety disorder (GAD).

Adverse event	Arm 1- Placebo n = 39	Arm 2- 25 μg MM120 n = 39	Arm 3- 50 μg MM120 n = 40	Arm 4- 100 μg MM120 n = 40	Arm 5- 200 μg MM120 n = 40
Overall
Serious adverse events	0/390%	0/390%	1/403%	0/400%	0/400%
Any non-serious event	22/3956%	30/3977%	36/4090%	39/4098%	40/40100%
Deaths	0/390%	0/390%	0/400%	0/400%	0/400%
Most frequent serious events
Panic Attack Psychiatric disorders	0/390%	0/390%	1/403%	0/400%	0/400%
Other events
Illusion Psychiatric disorders	3/398%	12/3931%	18/4045%	25/4063%	30/4075%
Nausea Gastrointestinal disorders	3/398%	3/398%	11/4028%	16/4040%	24/4060%
Headaches Nervous system disorders	9/3923%	5/3913%	9/4023%	14/4035%	11/4028%
Euphoric mood Psychiatric disorders	1/393%	2/395%	5/4013%	11/4028%	6/4015%
Hallucination, visual Psychiatric disorders	1/393%	6/3915%	9/4023%	9/4023%	6/4015%
Hyperhidrosis Skin and subcutaneous tissue disorders	0/390%	1/393%	4/4010%	9/4023%	5/4013%
Mydriasis Eye disorders	1/393%	1/393%	7/4018%	8/4020%	4/4010%
Paraesthesia Nervous system disorders	3/398%	2/395%	2/405%	2/405%	8/4020%
Tremor Nervous system disorders	0/390%	0/390%	3/408%	3/408%	8/4020%
Amxiety Psychiatric disorders	2/395%	4/3910%	5/4013%	4/4010%	6/4015%
Fatigue General disorders	1/393%	2/395%	6/4015%	4/4010%	4/4010%

showing the 12 most frequent of 50 reported event types· longer non-serious list truncated; totals complete

Safety and Efficacy of Low Dose MM120 for ADHD Proof of Concept Trial

NCT05200936Phase 253 enrolledDefinium Therapeutics US, Inc.Results posted Apr 2025

Observation window: From time of signing ICF (or screening visit) through study completion, typically 14 weeks.

Study summary · from ClinicalTrials.gov

This study measures the safety and efficacy of repeated low dose MM120 as treatment for ADHD in adults: a multi-center, randomized, double-blind, placebo-controlled

Adverse event	Arm 2- MM120 n = 27	Arm 1- Placebo n = 26
Overall
Serious adverse events	0/270%	0/260%
Any non-serious event	21/2778%	23/2688%
Deaths	0/270%	0/260%
Most frequent events
Headache Nervous system disorders	13/2748%	9/2635%
Nausea Gastrointestinal disorders	5/2719%	1/264%
Nasopharyngitis Infections and infestations	3/2711%	5/2619%
Illusion Psychiatric disorders	4/2715%	0/260%
Fatigue General disorders	4/2715%	1/264%
Insomnia Psychiatric disorders	3/2711%	1/264%
Disturbance in Attention Nervous system disorders	2/277%	2/268%
Apathy Psychiatric disorders	1/274%	2/268%
Abdominal pain Gastrointestinal disorders	1/274%	2/268%
Flatulence Gastrointestinal disorders	2/277%	0/260%
Feeling abnormal General disorders	2/277%	0/260%
Hot flush Vascular disorders	2/277%	0/260%

showing the 12 most frequent of 50 reported event types· longer non-serious list truncated; totals complete

Lysergic Acid Diethylamide (LSD)-Assisted Psychotherapy in People With Illness-related Anxiety

NCT00920387Phase 212 enrolledMultidisciplinary Association for Psychedelic StudiesResults posted Dec 2021

Observation window: From enrollment to end of Stage 2 (approximately 11 months)

Study summary · from ClinicalTrials.gov

This study will find out whether psychotherapy combined with lysergic acid diethylamide (LSD) is safe and is helpful in people who are anxious because they have a potentially fatal disease. The study will measure anxiety and quality of life before and after people have two sessions with either full or active placebo dose of LSD. They expect LSD-assisted psychotherapy to reduce anxiety and improve quality of life.

Adverse event	Full Dose LSD (200 mcg Stage 1) n = 8	Active Placebo LSD (20 mcg Stage 1) n = 4	Full Dose LSD (200 mcg Stage 2) n = 3
Overall
Serious adverse events	1/813%	1/425%	0/30%
Any non-serious event	8/8100%	4/4100%	3/3100%
Deaths	1/813%	0/40%	0/30%
Most frequent serious events
Metastic Esophageal Cancer Neoplasms benign, malignant and unspecified (incl cysts and polyps)	1/813%	0/40%	0/30%
Pyelonephritis Renal and urinary disorders	0/80%	1/425%	0/30%
Other events
Feeling Cold General disorders	6/875%	0/40%	1/333%
Illusions Psychiatric disorders	6/875%	1/425%	2/367%
Emotional Distress Psychiatric disorders	5/863%	1/425%	0/30%
Feeling Abnormal Psychiatric disorders	5/863%	2/450%	1/333%
Time Perception Altered Psychiatric disorders	4/850%	0/40%	2/367%
Mydriasis Eye disorders	3/838%	0/40%	0/30%
Anxiety Psychiatric disorders	2/825%	2/450%	1/333%
Anger Psychiatric disorders	1/813%	2/450%	0/30%
Perspiration Skin and subcutaneous tissue disorders	2/825%	0/40%	0/30%
Impaired Gait General disorders	2/825%	0/40%	2/367%

showing the 12 most frequent of 33 reported event types