CYB003 for Depression

Overseen By Anne-Marie Duchemin

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Ohio State University

Must be taking: Antidepressants

Must not be taking: Antipsychotics, MAOIs, Tricyclics, others

Disqualifiers: Schizophrenia, Bipolar, Substance use, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 1 day

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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. Assessments include interviews, self-report questionnaires, EEG and fMRI to measure symptoms and brain function.

Do I need to stop my current medications for the trial?

The trial requires that you have been on a stable dose of your current antidepressant medication (SSRI or SNRI) for at least a month before screening. However, you cannot be taking certain other medications like monoamine oxidase inhibitors, tricyclic antidepressants, or antipsychotics. The study team will review your medications to ensure they don't interfere with the trial.

Is CYB003 safe for humans?

Research on ketamine, which may be related to CYB003, shows that it has been tested for safety in humans, particularly for treatment-resistant depression. Studies suggest that ketamine can be safe when used in controlled settings, but there are still concerns about its long-term safety and potential side effects. ^{1 2 3 4 5}

Who Is on the Research Team?

Luan Phan, MD

Principal Investigator

Ohio State University

Are You a Good Fit for This Trial?

This trial is for individuals with major depressive disorder who are currently experiencing symptoms of depression and anxiety. Participants must be eligible based on certain health criteria not specified here.

Inclusion Criteria

I was assigned female or male at birth.

Participant has a BMI of 18 to 30 kg/m2 at Screening

I am between 21 and 65 years old.

Exclusion Criteria

My family has a history of mental health issues.

Presence or relevant history of certain medical conditions

QT interval corrected for heart rate >450 msec at Screening

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single oral dose of CYB003 or placebo with psychological support provided before, during, and after administration

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments at Day 2 and Day 21 post-administration

3 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• CYB003

Trial Overview The study tests a single dose of CYB003, a drug related to psilocybin, against a placebo in treating depression and anxiety. It includes interviews, questionnaires, EEG, and fMRI to evaluate symptoms and brain function.

How Is the Trial Designed?

Group I: CYB003 Experimental Treatment 1 Intervention

Participants will receive one dose of CYB003

Group II: Placebo Placebo Group 1 Intervention

Participants will receive one dose of placebo

Who Is Running the Clinical Trial?

Ohio State University

Lead Sponsor

Trials

891

Recruited

2,659,000+

Published Research Related to This Trial

In a study of 24,119 adolescents aged 12-18 diagnosed with major depressive disorder, treatment with antidepressants did not show a statistically significant increase in the risk of suicide attempts, suggesting that antidepressants may be safe in this population.

Longer treatment duration (at least 6 months) with antidepressants was associated with a reduced likelihood of suicide attempts compared to shorter treatment periods, indicating that sustained treatment may be beneficial for adolescents with depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Antidepressant treatment and risk of suicide attempt by adolescents with major depressive disorder: a propensity-adjusted retrospective cohort study. Valuck, RJ., Libby, AM., Sills, MR., et al.[2018]

Citations

1. New Zealand pubmed.ncbi.nlm.nih.gov

Antidepressant treatment and risk of suicide attempt by adolescents with major depressive disorder: a propensity-adjusted retrospective cohort study. [2018]

2. Denmark pubmed.ncbi.nlm.nih.gov

Achieving gains beyond response. [2019]

3. New Zealand pubmed.ncbi.nlm.nih.gov

Ketamine for treatment-resistant unipolar depression: current evidence. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Ketamine: A Review for Clinicians. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Safety and efficacy of repeated-dose intravenous ketamine for treatment-resistant depression. [2022]