Actively Recruiting
"A Study of a Deuterated Psilocin Analog (CYB003) in Humans With Major Depressive Disorder"
Led by Cybin IRL Limited · Updated on 2026-05-06
220
Participants Needed
46
Research Sites
89 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
"A Study of a Deuterated Psilocin Analog (CYB003) in Humans With Major Depressive Disorder"
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 to 85 years inclusive at Screening
- Diagnosed with Major Depressive Disorder (single or recurrent episode) as defined by DSM-5 TR
- Depression is moderate to severe at Screening and Baseline confirmed by clinical assessments
- On a stable dose of a single antidepressant medication for at least one month prior to Screening with inadequate response (less than 50% improvement)
- Body mass index (BMI) of 40 kg/m2 or less at Screening
- Able to refrain from nicotine use during dosing sessions (up to 8 hours)
- Registered with a healthcare professional who can confirm diagnosis and prior treatments
- Participants capable of producing sperm must use condom plus spermicide during trial and for 12 weeks after final dose if partner is of childbearing potential
- Participants of childbearing potential with partners capable of producing sperm must use highly effective contraception combined with condom plus spermicide during trial and for 12 weeks after final dose, and have negative pregnancy tests at Screening and Day 1
- Female participants capable of producing eggs must use contraception unless postmenopausal or permanently sterile
- Provide written informed consent including compliance with study requirements and restrictions
You will not qualify if you...
- Current or past diagnosis of schizophrenia spectrum or other psychotic disorders, bipolar disorder, or borderline personality disorder
- Medical diagnosis of ADHD if currently taking medication for ADHD
- Family history of schizophrenia, schizoaffective disorder, or bipolar disorder type 1 in first degree relatives
- Significant suicide risk or suicidal behaviors within the last 6 to 12 months or non-suicidal self-injury within 12 months
- Diagnosis of treatment-resistant MDD (failure to respond to 2 or more antidepressants from different classes)
- Electroconvulsive therapy, transcranial magnetic stimulation, deep brain stimulation, or vagal nerve stimulation for MDD within last 6 months
- Currently receiving monoamine oxidase inhibitors, tricyclic antidepressants, mirtazapine, trazodone, moclobemide, buspirone, ketamine or S-ketamine, or antipsychotics or mood stabilizers for MDD unless discontinued at least 14 days prior to Day 1
- Extensive lifetime use of psychedelics (more than 10 times) or use within 12 months prior to Screening
- Ketamine or S-ketamine use within 6 months prior to Screening
- Significant physical health issues interfering with trial participation
- Renal insufficiency
- Uncontrolled thyroid disorders unless controlled with medication
- Uncontrolled hypertension, arrhythmia, or abnormal heart rate or blood pressure
- Medical conditions affecting drug absorption, distribution, metabolism, or excretion
- History or presence of organic brain disorders such as epilepsy or seizures
- Known sensitivity to psilocin or formulation excipients
- Recent use of 5-HTP or St John's Wort within 14 days prior to medication administration
- Participation in another clinical trial with medication within 12 weeks prior to dosing
- Participants unwilling to abstain from sperm donation or egg donation as required
- Pregnancy, breastfeeding, planning to conceive, or unwillingness to abstain from egg donation during and after trial
- History of serotonin syndrome
- Unwillingness to consent to audio and video recording of sessions
- Staff or family members of trial sponsors or related organizations
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 46 locations
1
Scottsdale Research Institute
Phoenix, Arizona, United States, 85022
Actively Recruiting
2
Mountain Clinical Trials
Phoenix, Arizona, United States, 85050
Actively Recruiting
3
Noble Clinical Research
Tucson, Arizona, United States, 85704
Actively Recruiting
4
Del Sol Research Management
Tucson, Arizona, United States, 85715
Actively Recruiting
5
CenExel CIT (Clinical Innovations, Inc)
Bellflower, California, United States, 90706
Actively Recruiting
6
Kadima Neuropsychiatry Institute
La Jolla, California, United States, 92037
Actively Recruiting
7
Bespoke Treatment/Lipov Medical Group
Los Angeles, California, United States, 90025
Actively Recruiting
8
Catalina Research Institute
Montclair, California, United States, 91763
Actively Recruiting
9
Excell Research, Inc
Oceanside, California, United States, 92056
Actively Recruiting
10
Open Mind Therapeutics
San Francisco, California, United States, 94114
Actively Recruiting
11
Inland Psychiatric Medical Group Inc
San Juan Capistrano, California, United States, 92675
Actively Recruiting
12
Mountain View Clinical Research
Denver, Colorado, United States, 80209
Actively Recruiting
13
Starlight Clinical Research
Evergreen, Colorado, United States, 80439
Actively Recruiting
14
Research Centers of America
Hollywood, Florida, United States, 33024
Actively Recruiting
15
K2 Medical Research-Maitland
Maitland, Florida, United States, 32751
Actively Recruiting
16
Floridian Neuroscience Institute
Miami, Florida, United States, 33135
Actively Recruiting
17
Segal Trials West Broward
North Miami, Florida, United States, 33161
Actively Recruiting
18
Clinical Neuroscience Solutions, Inc
Orlando, Florida, United States, 32801
Actively Recruiting
19
Charter Research
Orlando, Florida, United States, 32803
Actively Recruiting
20
Combined Research Orlando Phase I-IV
Orlando, Florida, United States, 32807
Actively Recruiting
21
K2 Medical Research - Tampa
Tampa, Florida, United States, 33634
Actively Recruiting
22
Atlanta Center for Medical Research, CenExel
Atlanta, Georgia, United States, 30331
Actively Recruiting
23
CenExel iResearch Atlanta
Decatur, Georgia, United States, 30330
Actively Recruiting
24
CenExel iResearch Savannah
Savannah, Georgia, United States, 31405
Actively Recruiting
25
Great Lakes Clinical Trials, DBA Flourish Research
Chicago, Illinois, United States, 60640
Actively Recruiting
26
Uptown Research Institute
Chicago, Illinois, United States, 60640
Actively Recruiting
27
Psychiatric Medicine Associates, LLC
Skokie, Illinois, United States, 60076
Actively Recruiting
28
Atlas Psychiatric
New Orleans, Louisiana, United States, 70115
Not Yet Recruiting
29
DelRicht Research
New Orleans, Louisiana, United States, 70115
Actively Recruiting
30
Sunstone Medical, PC
Rockville, Maryland, United States, 20850
Actively Recruiting
31
Adams Clinical Boston
Boston, Massachusetts, United States, 02116
Actively Recruiting
32
Adams Clinical
Boston, Massachusetts, United States, 02472
Actively Recruiting
33
Elixia Health
Springfield, Massachusetts, United States, 01103
Actively Recruiting
34
Redbird Research, LLC
Las Vegas, Nevada, United States, 89119
Actively Recruiting
35
Oasis Clinical Trials
Las Vegas, Nevada, United States, 89121
Terminated
36
Global Medical Institutes, Princeton Medical Institute
Princeton, New Jersey, United States, 08540
Actively Recruiting
37
Adams Clinical Harlem
New York, New York, United States, 100029
Actively Recruiting
38
Adams Clinical Bronx
The Bronx, New York, United States, 10461
Actively Recruiting
39
Monroe Biomedical Research
Monroe, North Carolina, United States, 28112
Actively Recruiting
40
Neurobehavioral Clinical Research
North Canton, Ohio, United States, 44720
Actively Recruiting
41
Clinical Neuroscience Solutions, CNS Healthcare
Memphis, Tennessee, United States, 38119
Actively Recruiting
42
InSite Clinical Research, LLC
DeSoto, Texas, United States, 75115
Actively Recruiting
43
Zillan Clinical Research
Houston, Texas, United States, 77433
Actively Recruiting
44
AIM Trials
Plano, Texas, United States, 75093
Withdrawn
45
Cedar Clinical Research
Murray, Utah, United States, 84107
Actively Recruiting
46
Inner Space Research, LLC
Orem, Utah, United States, 84058
Actively Recruiting
Research Team
C
Clinical Development
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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