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New treatment option for Depression
Official title A Mechanistic Study to Assess a Single Dose of CYB003 in Participants With Depression and Anxiety
ClinicalTrials.gov ID: NCT06820723
What this study is testing
What is CYB003?
CYB003 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for depression.
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 goal of this study is to learn how psychedelics may help symptoms of depression and anxiety. Participants with major depressive disorder experiencing symptoms of depression and anxiety will receive one dose of either a drug related to psilocybin or a placebo.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 to 65
You may be able to join if
- Participant is assigned female or male at birth.
- Participant is aged between 21 to 65 years, inclusive, at Screening.
- Participant has a BMI of 18 to 30 kg/m2, inclusive, at Screening.
- Participant is ≥60 kg.
- Participant has a diagnosis of MDD (as defined in the DSM-5 established through a clinician interview that includes the Mini-International...
You likely can't join if
- A reduction in the MADRS score of 25% or more between Screening and Baseline.
- Failure to respond to \>2 antidepressant treatments given at an adequate dose for an adequate duration during the current episode of depression.
- Current or previously diagnosis of schizophrenia spectrum or other psychotic disorders, including schizophrenia, schizoaffective disorder...
- Clinically significant risk of suicidality, as determined through a comprehensive psychiatric interview that incorporates the Columbia Suicide...
- History of substance use disorder within the 12 months, as assessed by a structured clinical interview (Mini International Neuropsychiatric Interview...
- Currently receiving a monoamine oxidase inhibitor, tricyclic antidepressant, other non-SSRI or non-SNRI antidepressants (e.g. bupropion, mirtazapine...
See the full eligibility criteria
Who can join
- Participant is assigned female or male at birth.
- Participant is aged between 21 to 65 years, inclusive, at Screening.
- Participant has a BMI of 18 to 30 kg/m2, inclusive, at Screening.
- Participant is ≥60 kg.
- Participant has a diagnosis of MDD (as defined in the DSM-5 established through a clinician interview that includes the Mini-International Neuropsychiatric Interview)
- Depression severity moderate to severe based on MADRS score ≥21.
- Anxiety severity moderate to severe based on GAD-7 ≥10.
- Inadequate response to current antidepressant medication in current episode of depression.
- Participant has been on a stable dose (no more than 50% change) of antidepressant medication (SSRI or SNRI) in the last month prior to Screening.
- Participants capable of producing sperm must use a condom during the trial and for 3 months after their dose of trial medication, if their partner is a person of childbearing potential. In addition, their partner of...
- Participants of childbearing potential must agree to use a highly effective method of contraception (i.e., failure rate less than 1% when used consistently and correctly) in combination with use of a condom by a partner...
- Participants of non-childbearing potential who are or were capable of producing eggs (ova) must be postmenopausal or permanently sterile following hysterectomy, bilateral salpingectomy or bilateral oophorectomy...
- Provision of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
What rules you out
- A reduction in the MADRS score of 25% or more between Screening and Baseline.
- Failure to respond to \>2 antidepressant treatments given at an adequate dose for an adequate duration during the current episode of depression.
- Current or previously diagnosis of schizophrenia spectrum or other psychotic disorders, including schizophrenia, schizoaffective disorder, schizotypal disorder, schizophreniform disorder or brief psychotic disorder...
- Clinically significant risk of suicidality, as determined through a comprehensive psychiatric interview that incorporates the Columbia Suicide Severity Rating Scale (CSSRS); a score of 4 or higher on the suicidal...
- History of substance use disorder within the 12 months, as assessed by a structured clinical interview (Mini International Neuropsychiatric Interview [MINI], Version 7.0.2) or determined by self-report, or intake of...
- Currently receiving a monoamine oxidase inhibitor, tricyclic antidepressant, other non-SSRI or non-SNRI antidepressants (e.g. bupropion, mirtazapine, etc), an antipsychotic or a mood stabilizer.
- Exposure to psilocin, or any other psychedelics, such as ayahuasca, mescaline, LSD or peyote more than 10 times in the last 10 years, or any psychedelic use within 6 months prior to Screening.
- Use of psychotropic medicine/supplement (or medicine/supplement that would interact with psilocybin) during the 28 days before dosing. Participants may take a stable chronic dose of antidepressant medication(s) and/or...
- Family history of schizophrenia or schizoaffective disorder (first degree relatives), or bipolar disorder type 1 (first degree relatives).
- Clinically relevant history of abnormal physical health interfering with the study as determined by medical history and physical examinations obtained during Screening as judged by the Investigator (including but not...
- Participant has a presence or relevant history of any of the following medical conditions: organic brain disorders (e.g., epilepsy, seizure, intracranial hypertension, intracranial bleed and aneurysmal disease, brain...
- Diagnosis of hypertension or arrhythmia.
- Clinically relevant abnormal heart rate (resting supine heart rate \>100 bpm) or blood pressure (resting supine systolic blood pressure (SBP) above 140 mmHg or diastolic blood pressure (DBP) above 90 mmHg) at screening...
- Presence of clinically significant ECG abnormalities at the Screening visit, as defined by medical judgement.
- QT interval corrected for heart rate using Fridericia's formula (QTcF) \>450 msec at Screening, following triplicate ECG readings.
- Hypothyroidism and/or current abnormal thyroid function tests. In case of uncertain or questionable screening thyroid function test results, the TSH test may be repeated once during screening. The TSH test must be...
- Clinically relevant abnormal laboratory results (including hepatic and renal panels, complete blood count, chemistry panel and urinalysis), 12-lead ECG and vital signs, or physical findings at Screening. In case of...
- Other eligibility considerations (i.e., participant personal circumstances, behavior, and/or any current problem that might interfere with participation or that is incompatible with establishment of rapport or safe...
- History or clinical evidence of any disease and/or existence of any surgical or medical condition which might interfere with the absorption, distribution, metabolism or excretion (ADME) of the study drug.
- Any other concomitant disease or condition that could interfere with, or for which the treatment might interfere with, the conduct of the study as outlined in this Protocol, or that would, in the opinion of the...
- Participant is not fluent in English.
- Aspartate aminotransferase (AST), alanine transaminase (ALT), gamma-glutamyl transferase (GGT) or total bilirubin levels ≥1.5 x the upper limit of normal (ULN) at Screening. These laboratory evaluations may be repeated...
- Positive urine test for drugs of abuse or alcohol breath test at Screening or Day 1. A positive test for cannabinoids (e.g., marijuana) at Screening may not exclude a participant if after discussion with and evaluation...
- Participant who consumes excessive amounts of caffeine (e.g., coffee, tea, caffeinated sodas) or (methyl) xanthines (e.g., chocolate) based on the Investigator's determination and discretion.
- The participant has participated in a clinical study and has received a medication or a new chemical entity within 3 months prior to dosing of current study medication.
- Known sensitivity to psilocin and/or any excipients present in the formulation. Known fructose malabsorption or intolerance, since the orange drink vehicle for study drug contains fructose.
- Participant is taking or has taken any drugs known to inhibit monoamine oxidase within 28 days prior to study drug administration.
- Participant is taking or has taken OTC doses of 5-hydroxytryptophan or St John's Wort within 28 days prior to study drug administration.
- Strenuous exercise within 48 hours prior to each visit, and while at the study site.
- Participants capable of producing sperm who will not abstain from sperm donation between first dosing and 3 months after final dosing.
- Participants of childbearing potential who are pregnant, breastfeeding or planning to conceive.
The study team makes the final eligibility decision.
Where it's taking place
- Columbus, Ohio, United States
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, 21 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Columbus, Ohio, United States. 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.