Clinical trials: Psilocybin
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
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 Multiple Doses of MLS101 in Healthy Participants
MLS101 is being developed as a low dose psilocybin, that can be administered to treat neurological and psychiatric conditions. The purpose of this clinical trial is to assess how safe and tolerated MLS101 is; to see how MLS101 is…
- Trial name
- NCT06643637
- Testing
- Psilocybin
- Where
- Australia
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- MycoMedica Life Sciences PBC
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
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.
Short Lasting Unilateral Neuralgiform Headache Attacks
Phase 1b Study in Patients With Short-Lasting Unilateral Neuralgiform Headache Attacks (SUNHA)
This exploratory open-label phase 1b, ascending dose study is to evaluate the effects of psilocybin on cognition in patients with Chronic Short-Lasting Unilateral Neuralgiform Headache Attacks (SUNHA)
- Trial name
- NCT04905121
- Testing
- Psilocybin
- Where
- United Kingdom
- Volunteers
- 4 people
- Sponsor
- Beckley Psytech Limited
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
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
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
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
Adjustment Disorder, Adjustment Disorder With Anxious Mood
Psilocybin-Assisted Psychotherapy in Cancer Patients With Adjustment Disorder
This study is assessing the efficacy and safety of NPX-5 in psilocybin-assisted psychotherapy for the treatment of adjustment disorder due to cancer diagnosis.
- Conditions
- Adjustment Disorder, Adjustment Disorder With Anxious Mood, Cancer, Cancer Cachexia
- Trial name
- NCT07072728
- Testing
- Psilocybin therapy
- Where
- 5 sites in Australia
- Volunteers
- 87 people
- Sponsor
- Psyence Australia Pty Ltd
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.