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New treatment option for Major Depressive Disorder (MDD)
Official title A Study of a Deuterated Psilocin Analog (CYB003) in Humans With Major Depressive Disorder
ClinicalTrials.gov ID: NCT06793397
What this study is testing
What is CYB003?
CYB003 is an investigational medicine, being studied as a potential treatment for major depressive disorder (mdd).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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. For more information about the EMBRACE study, including participating study locations, and to register your interest in learning more about participation, please visit the study website: https://embrace-mdd-trial.com/
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 85
You may be able to join if
- Participants must meet all the following criteria to be included in the trial:
- Age18 to 85 years.
- Participant has a diagnosis of MDD (single or recurrent episode as defined by DSM-5 TR [if single episode, duration of ≥4 weeks and ≤24 months] and...
- Moderate to severe depression at Screening and Baseline, independently confirmed.
- Participants have been on a stable dose of antidepressant medication (label specified) at an adequate dose in the last 4 weeks prior to Screening and...
You likely can't join if
- Participants with any of the following characteristics/conditions will be excluded from trial participation:
- Current or previously diagnosed schizophrenia spectrum or other psychotic disorders, including schizophrenia, schizoaffective disorder, schizotypal...
- Participants with a medical diagnosis of attention deficit hyperactivity disorder (ADHD) will be excluded if currently taking medication for ADHD.
- Family history of schizophrenia, schizoaffective disorder, or bipolar disorder type 1 (first-degree relatives).
- Significant suicide risk within the past 6 months, during the Screening Period, or at Baseline; or (b) suicidal behaviors within 12 months of...
- Current or previous diagnosis of treatment-resistant MDD, defined as failure to respond to 2 or more antidepressant treatments of 2 different classes...
See the full eligibility criteria
Who can join
- Participants must meet all the following criteria to be included in the trial:
- Age18 to 85 years.
- Participant has a diagnosis of MDD (single or recurrent episode as defined by DSM-5 TR [if single episode, duration of ≥4 weeks and ≤24 months] and established as per evaluation by the Investigator. The first MDD...
- Moderate to severe depression at Screening and Baseline, independently confirmed.
- Participants have been on a stable dose of antidepressant medication (label specified) at an adequate dose in the last 4 weeks prior to Screening and has had an inadequate response (less than 50% improvement), as judged...
- Participant has a body mass index (BMI) of 40 kg/m2 or less (BMI ≤40 kg/m2), inclusive, at Screening.
- Participant is able to refrain from nicotine use during the dosing session (up to 8 hours).
- Participants capable of producing sperm must use a condom plus spermicide during the trial and for 12 weeks after their final dose of trial medication, if their partner is a person of childbearing potential.
- Participants of childbearing potential who have a partner capable of producing sperm must agree to use a highly effective method of contraception in combination with the use of a condom plus spermicide during the trial...
- Participants of non-childbearing potential who are or were capable of producing eggs (ova) must have been postmenopausal or permanently sterile following hysterectomy, bilateral salpingectomy, or bilateral oophorectomy.
- Participants have provided written informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form.
What rules you out
- Participants with any of the following characteristics/conditions will be excluded from trial participation:
- Current or previously diagnosed schizophrenia spectrum or other psychotic disorders, including schizophrenia, schizoaffective disorder, schizotypal disorder, schizophreniform disorder, brief psychotic disorder, current...
- Participants with a medical diagnosis of attention deficit hyperactivity disorder (ADHD) will be excluded if currently taking medication for ADHD.
- Family history of schizophrenia, schizoaffective disorder, or bipolar disorder type 1 (first-degree relatives).
- Significant suicide risk within the past 6 months, during the Screening Period, or at Baseline; or (b) suicidal behaviors within 12 months of Screening; or (c) clinical assessment of significant suicidal risk during...
- Current or previous diagnosis of treatment-resistant MDD, defined as failure to respond to 2 or more antidepressant treatments of 2 different classes given at an adequate dose (label specified) for an adequate duration...
- Has had electroconvulsive treatment, transcranial magnetic stimulation, deep brain stimulation, or vagal nerve stimulation for any episode of MDD in the last 6 months.
- Currently receiving a monoamine oxidase inhibitor, tricyclic antidepressants, mirtazapine, trazodone, moclobemide, buspirone, or an antipsychotic or mood stabilizer. Note: if receiving these medications are for another...
- Participant report of (or if available in medical record) exposure to psilocin, or 5-HT2a receptor agonists, or any other psychedelics, such as ayahuasca, mescaline, lysergic acid diethylamide, peyote, or...
- Participant report of (or if available in medical record) treatment with ketamine or S-ketamine use within 6 months prior to Screening.
- Clinically relevant history of abnormal physical health interfering with the trial (including but not limited to, neurological, cardiovascular, respiratory, gastrointestinal [including dyspepsia or gastroesophageal...
- Has hypothyroidism or hyperthyroidism, unless controlled on appropriate medication.
- Current diagnosis of uncontrolled hypertension or an arrhythmia, or clinically relevant abnormal results for heart rate.
- Participants have a presence or relevant history of organic brain disorders.
- Participant is taking or has taken OTC doses of 5-HTP or St John's Wort within prior to trial medication administration.
- Donation of blood or plasma within 4 weeks prior to first dosing and until 4 weeks after final dosing.
- Participants capable of producing sperm who will not abstain from sperm donation between first dosing and 12 weeks after final dosing.
- Participants of childbearing potential who are pregnant, breastfeeding, planning to conceive or unwilling to abstain from egg (ova) donation between first dosing and 12 weeks after final dosing.
- History of serotonin syndrome.
- Unwilling to consent to audio and video recording of psychological support and dosing sessions.
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Gilbert, Arizona, United States
- Little Rock, Arkansas, United States
- Glendale, California, United States
- Imperial, California, United States
- Los Angeles, California, United States
- Orange, California, United States
- San Juan Capistrano, California, United States
- Santa Monica, California, United States
- Stanford, California, United States
- New Haven, Connecticut, United States
- Jacksonville, Florida, United States
- Maitland, Florida, United States
- Naples, Florida, United States
- Atlanta, Georgia, United States
- Marietta, Georgia, United States
- Chicago, Illinois, United States
- Marrero, Louisiana, United States
- New Orleans, Louisiana, United States
- Baltimore, Maryland, United States
+ 37 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Gilbert, Arizona, United States; Little Rock, Arkansas, United States; Glendale, California, United States; Imperial, California, United States; Los Angeles, California, United States and 51 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.