Clinical trials: Psilocybin
Fragile X Syndrome, Behavior
An Investigation of Psilocybin on Behavioural and Cognitive Symptoms of Adults With Fragile X Syndrome
Diverse symptomatology makes Fragile X Syndrome (FXS) difficult to treat, and currently there are no approved prevention or treatment methods for FXS.
- Conditions
- Fragile X Syndrome, Behavior, Cognitive Dysfunction
- Trial name
- NCT05832255
- Testing
- Psilocybin, 1.5 mg
- Where
- Canada
- Volunteers
- 10 people
- Sponsor
- Nova Mentis Life Science Corp
Irritable Bowel Syndrome
Assessment of Psilocybin (TRP-8802) in Concert With Psychotherapy in Patients With Irritable Bowel Syndrome (IBS)
Participants with IBS (all subtypes) and with no exclusionary comorbid psychiatric or medical disorders will be enrolled in the study.
- Trial name
- NCT06206265
- Testing
- TRYP-0082, Psychotherapy
- Where
- United States
- Volunteers
- 14 people
- Sponsor
- TRYP Therapeutics
Treatment Resistant Depression
Long Term Follow Up Study to COMP 001 And COMP 003 Trials (P-TRD LTFU)
The primary objective of this study is to assess the long-term efficacy of psilocybin with respect to use of new antidepressant treatment, hospitalisations for depression, suicidality, and depressive severity rated using the…
- Trial name
- NCT04519957
- Where
- 8 sites in United States, Czechia and 3 more
- Volunteers
- 66 people
- Sponsor
- COMPASS Pathways
Anorexia Nervosa
Efficacy and Safety of COMP360 Psilocybin Therapy in Anorexia Nervosa: a Proof-of-concept Study
Efficacy and Safety of COMP360 Psilocybin therapy in Anorexia Nervosa: a Proof-of-concept Study
- Trial name
- NCT05481736
- Testing
- Psilocybin
- Where
- 5 sites in United States, Ireland and 1 more
- Volunteers
- 32 people
- Sponsor
- COMPASS Pathways
Post Traumatic Stress Disorder
The Safety and Tolerability of COMP360 in Participants With Post-traumatic Stress Disorder
The Safety and Tolerability of COMP360 in Participants with Post-traumatic Stress Disorder
- Trial name
- NCT05312151
- Testing
- Psilocybin
- Where
- 3 sites in United States, United Kingdom
- Volunteers
- 22 people
- Sponsor
- COMPASS Pathways
Mood Disturbance, Mood Change
Mood and Cognitive Effects of Psilocybin in Healthy Participants
This study is seeking to find the optimal microdose or low dose of psilocybin (magic mushrooms) that provides general enhancements to mood, memory, sleep, and other measures of general well-being without any hallucinogenic…
- Conditions
- Mood Disturbance, Mood Change, Sleep Disturbance, Drug Effect
- Trial name
- MELO (NCT05252598)
- Testing
- Psilocybin, Inonotus Obliquus Whole Extract
- Volunteers
- healthy volunteers welcome
- Sponsor
- Optimi Health Corporation
Healthy Controls
Identification of a Safe and Non-Psychedelic Dose of Psilocybin
This randomized, double-blind, placebo-controlled, single ascending dose study will evaluate psilocybin in healthy adult subjects.
- Trial name
- NCT07710027
- Where
- Canada
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Diamond Therapeutics Inc.
Healthy Volunteer
A Study Assessing Brain Activity, Safety, Tolerability, and Pharmacokinetics Following Multiple Doses of MLS101 (Psilocybin) in Healthy Volunteers
MLS101 is being developed as a low dose psilocybin, that can be administered to treat neurological and psychiatric conditions. The purpose of this trial is to investigate brain activity, safety, tolerability, and PK of multiple…
- Trial name
- NCT07050368
- Testing
- Psilocybin
- Where
- United Kingdom
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- MycoMedica Life Sciences PBC
Alcohol Use Disorder
Psilocybin-Assisted Psychotherapy in Adults With Alcohol Use Disorder (AUD)
The goal of this clinical trial is to investigate treatment with psilocybin and psychotherapy for the treatment of people with Alcohol Use Disorder (AUD).
- Trial name
- NCT05646303
- Testing
- Psilocybin
- Where
- 12 sites in Canada, Finland
- Volunteers
- 128 people
- Sponsor
- Clairvoyant Therapeutics
Treatment Resistant Disorders, Post Traumatic Stress Disorder
Investigating the Therapeutic Effects of Psilocybin in Treatment-Resistant Post-Traumatic Stress Disorder
Post-traumatic stress disorder (PTSD) is a complex disorder expressed as a variety of neurobiological symptoms, including anxiety, re-experiencing, hyperarousal, and avoidance symptoms, along with comorbidities such as anxiety…
- Trial name
- NCT05243329
- Testing
- Psilocybin
- Where
- Canada
- Volunteers
- 20 people
- Sponsor
- Halucenex Life Sciences Inc.
Major Depressive Disorder
Phase III Long-term Extension Trial to Assess Safety and Efficacy of CYB003 in MDD (EXTEND)
This is a long- term extension of the double-blind trials APPROACH (CYB003-002) and EMBRACE (CYB003-003). Its aim is to examine the safety and long-term efficacy of CYB003 in participants with MDD.
- Trial name
- EXTEND (NCT06605105)
- Testing
- CYB003
- Where
- 49 sites in United States, Australia and 3 more
- Volunteers
- 468 people
- Sponsor
- Cybin IRL Limited
Major Depressive Disorder
A Study of a Psilocybin Analog (CYB003) in Healthy Participants With and Without Major Depressive Disorder
The purpose of this study is to determine the safety and tolerability of ascending oral doses of CYB003 in healthy participants with and without major depressive disorder (MDD).
- Trial name
- NCT05385783
- Testing
- CYB003, Psychotherapy, Psychological Support
- Where
- 3 sites in United States
- Volunteers
- 57 people, healthy volunteers welcome
- Sponsor
- Cybin IRL Limited
Psilocybin, Psychotherapy, Group
Psychedelic-assisted Group Program for First Responders
This study is a two-group feasibility study of oral psilocybin combined with a 12-week group-based program, customized for firefighters.
- Trial name
- NCT06471959
- Testing
- Psilocybin
- Where
- Canada
- Volunteers
- 32 people
- Sponsor
- Empower Research Inc
PTSD - Post Traumatic Stress Disorder, PTSD
Redefine Study: A Study Evaluating the Efficacy, Safety, and Tolerability of COMP360 in Participants With Post-traumatic Stress Disorder
The Redefine Study (COMP202) is testing COMP360 to see if it may reduce post-traumatic stress disorder (PTSD) symptoms when administered alongside monitoring and support from a trained study team.
- Conditions
- PTSD - Post Traumatic Stress Disorder, PTSD, PTSD Symptoms, PTSD, Post Traumatic Stress Disorder
- Trial name
- Redefine (NCT07570654)
- Testing
- COMP360 psilocybin
- Where
- 10 sites in United States, Canada
- Volunteers
- 300 people
- Sponsor
- COMPASS Pathways
Major Depressive Disorder
A Phase II, Multicentre, Randomised, Double-blind, Controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Efficacy of COMP360 in Participants With Recurrent Major Depressive Disorder
Safety, Tolerability, pharmacokinetics and efficacy of a single administration of COMP360 in participants with recurrent Major Depressive Disorder.
- Trial name
- NCT05733546
- Testing
- Psilocybin
- Where
- 5 sites in United States
- Volunteers
- 102 people
- Sponsor
- COMPASS Pathways
Binge Eating Disorder
Evaluation of Psilocybin (TRP-8802) in the Treatment of Binge Eating Disorder
To better understand the potential benefits of psychedelics in overeating disorders, Tryp Therapeutics will conduct a safety and feasibility clinical trial using TRP 8802 among individuals with Binge Eating Disorder.
- Trial name
- NCT05035927
- Testing
- TRYP-0082, Psychotherapy
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- TRYP Therapeutics
Healthy Volunteers
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MLS101 in Healthy Participants
MLS101 is being developed as a low dose psilocybin, that can be administered to treat various neurological and psychiatric conditions.
- Trial name
- NCT06326606
- Testing
- Psilocybin
- Where
- Australia
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- MycoMedica Life Sciences PBC
Treatment Resistant Depression
The Safety and Efficacy Of Psilocybin as an Adjunctive Therapy in Participants With Treatment Resistant Depression
The Safety and Efficacy of Psilocybin as an Adjunctive Therapy in Participants with Treatment-Resistant Depression
- Trial name
- NCT04739865
- Testing
- Psilocybin
- Where
- 2 sites in United States, Ireland
- Volunteers
- 19 people
- Sponsor
- COMPASS Pathways
Post-traumatic Stress Disorder, Depression
Evaluation of Psilocybin-Assisted Psychotherapy in Treating Severe Depression in Patients With PTSD
Post-Traumatic Stress Disorder (PTSD) is a mental disorder that may develop in people who have been exposed to a traumatic event, including actual or threatened death, serious injury, or sexual violence.
- Trial name
- SUMMIT-90 (NCT06141876)
- Testing
- APEX-002-A02
- Volunteers
- 160 people
- Sponsor
- Apex Labs Ltd.
Premenstrual Dysphoric Disorder ( PMDD), PMDD
MLS101 Study in PMDD
The goal of this clinical trial is to learn if MLS101 (psilocybin) is a possible treatment for women with Premenstrual Dysphoric Disorder (PMDD).
- Trial name
- NCT07818720
- Testing
- MLS101 psilocybin
- Volunteers
- 32 people
- Sponsor
- MycoMedica Life Sciences PBC