Clinical trials: Psilocybin
Major Depressive Disorder
"A Study of a Deuterated Psilocin Analog (CYB003) in Humans With Major Depressive Disorder"
The purpose of this study is to examine the efficacy, safety, and tolerability of CYB003 compared to matching placebo as adjunctive treatment in participants with MDD.
- Trial name
- APPROACH (NCT06564818)
- Testing
- CYB003, Psychological Support
- Where
- 45 sites in United States
- Volunteers
- 223 people
- Sponsor
- Cybin IRL Limited
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
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
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
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.
Treatment Resistant Depression
Efficacy, Safety, and Tolerability of Two Administrations of COMP360 in Participants With TRD
Efficacy, Safety, and Tolerability of two administrations of COMP360 in participants with treatment-resistant depression (TRD)
- Trial name
- NCT05711940
- Testing
- Psilocybin
- Where
- 116 sites in United States, Canada and 10 more
- Volunteers
- 572 people
- Sponsor
- COMPASS Pathways
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
Treatment Resistant Depression
Efficacy, Safety, and Tolerability of COMP360 in Participants With TRD
Efficacy, Safety, and Tolerability of a single administration of COMP360 in participants with treatment-resistant depression (TRD)
- Trial name
- NCT05624268
- Testing
- Psilocybin
- Where
- 40 sites in United States
- Volunteers
- 258 people
- Sponsor
- COMPASS Pathways
Major Depressive Disorder (MDD), Depression in Adults
A Study of a Deuterated Psilocin Analog (CYB003) in Humans With Major Depressive Disorder
The purpose of this study is to determine the efficacy, safety and tolerability of CYB003 compared to matching placebo as adjunctive treatment in patients with MDD.
- Conditions
- Major Depressive Disorder (MDD), Depression in Adults, Depression - Major Depressive Disorder, Depression Disorders
- Trial name
- EMBRACE (NCT06793397)
- Testing
- CYB003, Psychological Support
- Where
- 79 sites in United States, Australia and 6 more
- Volunteers
- 330 people
- Sponsor
- Cybin IRL Limited
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
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
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
Treatment Resistant Depression
The Safety and Efficacy of Psilocybin in Participants With Treatment Resistant Depression
The Safety and Efficacy of Psilocybin in Participants with Treatment Resistant Depression
- Trial name
- P-TRD (NCT03775200)
- Testing
- Psilocybin
- Where
- 25 sites in United States, Canada and 8 more
- Volunteers
- 233 people
- Sponsor
- COMPASS Pathways
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
Depression, Major Depressive Disorder
Effect of SSRIs on Response to Psilocybin Therapy
This study is an open-label, single-arm, within-subjects design in individuals with mild-moderate Major Depressive Disorder (MDD). All participants will receive a single dose of 25mg of psilocybin in a therapeutic setting.
- Conditions
- Depression, Major Depressive Disorder, Mild Depression, Moderate Depression
- Trial name
- NCT05594667
- Testing
- Psilocybin
- Where
- Canada
- Sponsor
- Cybin Therapeutics Inc.
Healthy Volunteers, Major Depressive Disorder
ELE-101 Safety & Tolerability Study in Healthy Participants and Patients With Depression
A study to assess the safety and tolerability of a drug called ELE-101 and see how the body absorbs and removes the drug and how it affects the body in healthy adult participants (Part 1) and in patients with depression (Part 2).
- Conditions
- Healthy Volunteers, Major Depressive Disorder, Depression
- Trial name
- NCT05434156
- Testing
- ELE-101
- Where
- 2 sites in United Kingdom
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- Eleusis Therapeutics
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
Stimulant Use Disorder
PEX010-Assisted Therapy for Stimulant Use Disorder: A Safety, Feasibility and Efficacy Study
The goal of this clinical trial is to learn if PEX010 is effective for the treatment of Stimulant Use Disorder in adults. The study will also assess the safety and feasibility of administering PEX010 to this population.
- Trial name
- PATSUD (NCT06666010)
- Testing
- PEX010-Assisted Therapy, PEX010(01)
- Volunteers
- 86 people
- Sponsor
- Filament Health Corp.
Personality
Personality and Drug Use (PDU)
The study aims to assess whether the use of drugs relates to personality ratings. Specifically, we plan to investigate if people with different histories of substance use differentiate on personality assessments (current and…
- Trial name
- PDU (NCT05180149)
- Volunteers
- healthy volunteers welcome
- Sponsor
- Quantified Citizen Technologies Inc.
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