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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a new psychedelic treatment, CYB003, might help adults with major depressive disorder who also experience anxiety. Participants will receive either a dose of CYB003 or a placebo to determine if it improves their symptoms and brain function. Ideal candidates for this trial are those with moderate to severe depression and anxiety, who have not responded well to current antidepressant medications, and are on a stable dose of SSRI or SNRI antidepressants. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

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 there any evidence suggesting that CYB003 is likely to be safe for humans?

Research has shown that CYB003 is generally safe for humans. In one study, all participants responded to the treatment, and 71% were in remission a year after receiving two doses. This outcome suggests the treatment is effective and has few side effects. Additionally, the FDA has granted CYB003 a Breakthrough Therapy designation, indicating that early data on safety and effectiveness is promising. Although the treatment remains under study, these early results are encouraging. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for depression?

CYB003 is unique because it is derived from psilocybin, a compound found in certain mushrooms, which targets the brain's serotonin receptors differently than standard antidepressants like SSRIs or SNRIs. Most treatments for depression require weeks to show effectiveness, but CYB003 has the potential to produce rapid results. Researchers are excited because it could offer a new mechanism of action for treating depression, potentially benefiting those who don't respond well to existing medications.

What evidence suggests that CYB003 might be an effective treatment for depression?

Research has shown that CYB003, a drug similar to psilocybin, may help treat major depressive disorder (MDD). In one study, all participants improved after treatment, and 71% were symptom-free 12 months after just two doses of CYB003. Other studies have also found significant and lasting improvements in depression symptoms over four months. In this trial, participants will receive either one dose of CYB003 or a placebo. These findings suggest that CYB003 could be a helpful option for people dealing with depression. ^{1 3 5 6 7}

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. ir.cybin.com ir.cybin.com/investors/news/news-details/2024/Cybin-Reports-Positive-Phase-2-Data-for-CYB003-Demonstrating-Breakthrough-12-Month-Efficacy-in-Treating-Major-Depressive-Disorder/default.aspx

Cybin Reports Positive Phase 2 Data for CYB003 ... 100% of participants were responsive to treatment and 71% of participants were in remission at 12 months after just two 16 mg doses of CYB003.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05385783

A Study of a Psilocybin Analog (CYB003) in Healthy ... The purpose of this study is to determine the safety and tolerability of ascending oral doses of CYB003 in healthy participants with and without major ...

3. psychiatrictimes.com psychiatrictimes.com/view/cyb003-for-the-adjunctive-treatment-of-major-depressive-disorder

CYB003 for the Adjunctive Treatment of Major Depressive ... CYB003 already saw positive 4-month efficacy data in MDD in phase 2 studies. Investigators noted robust and sustained improvements in symptoms ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S016517812400622X

Efficacy and safety of psilocybin in the treatment of Major ... This meta-analysis supports psilocybin's efficacy in treating MDD, particularly at a 25 mg dose, showing a time-dependent therapeutic effect.

5. clinicaltrials.ucsf.edu clinicaltrials.ucsf.edu/trial/NCT06564818

Deuterated Psilocin Analog (CYB003) in Humans With ... The purpose of this study is to examine the efficacy, safety, and tolerability of CYB003 compared to matching placebo as adjunctive treatment in participants ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06564818

"A Study of a Deuterated Psilocin Analog (CYB003) in ... The purpose of this study is to examine the efficacy, safety, and tolerability of CYB003 compared to matching placebo as adjunctive treatment in ...

7. pharmacytimes.com pharmacytimes.com/view/fda-breakthrough-therapy-designation-granted-to-novel-psychedelic-molecule-cyb003-for-major-depressive-disorder

FDA Breakthrough Therapy Designation Granted to Novel ... Efficacy and Safety Data: Data from the phase 2 trial of CYB003 for MDD showed robust and sustained improvements in depression symptoms, with ...