A Mechanistic Study to Assess a Single Dose of CYB003 in Participants With Depression and Anxiety
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age21-65
SponsorOhio State University
About 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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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; current or previous history of bipolar disorder, or current personality disorder (as determined by MINI at Screening).
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 ideation subscale of C-SSRS (past 6 months) or any suicidal behaviour (lifetime), would be exclusionary.
Trial design
Treatments tested in this trial
- CYB003
- Placebo
Treatment groups
40 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov