Status:
RECRUITING
Investigation to Understand and Optimize Psilocybin
Lead Sponsor:
Charles Raison
Collaborating Sponsors:
Usona Institute
Tiny Blue Dot Foundation
Conditions:
Depression
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
This study will examine the effects of a single dose of psilocybin, administered with psychological support, on symptoms of depression. It will also assess whether different post-dosing interventions,...
Detailed Description
One hundred forty-one adults ages 18 to 70 experiencing a major depressive episode of at least 60 days duration of moderate or greater severity at screening will be enrolled to obtain evaluable data o...
Eligibility Criteria
Inclusion
- Current diagnosis of Major Depressive Disorder (MDD), with a depressive episode lasting ≥ 60 consecutive days at the time of screening, as confirmed by structured clinical interview
- Medically healthy, as determined by the screening physician, with no significant medical conditions that would interfere with participation or affect the safety of the subject.
Exclusion
- History or presence of any psychiatric or medical condition that, in the opinion of the investigator, could pose a safety risk, interfere with participation, or confound study results (e.g., bipolar disorder, psychosis, seizure disorder, or cardiovascular disease).
- Known family history of a psychotic disorder (e.g., schizophrenia or schizoaffective disorder) in a first-degree relative (biological parent, full sibling, or child).
- Current active suicidal ideation with a specific plan within the prior 2 weeks, as assessed via clinical interview and validated instrument (e.g., C-SSRS).
- Suicide attempt within the prior 6 months, regardless of intent or lethality.
- Current diagnosis of a substance use disorder
- Abnormal ECG at screening that may increase risk during participation (e.g., prolonged QTc, arrhythmias, or other clinically significant findings as determined by the study physician).
- Unwilling or unable to discontinue prescription psychotropic medications (e.g., antidepressants, antipsychotics, anxiolytics, lithium, anticonvulsants, or mood stabilizers) for the duration of study participation, including any necessary washout period as determined by the investigator.
- Any condition, finding, or behavior (including suspected deception or noncompliance) that, in the opinion of the investigator, renders the participant unsuitable for the study or likely to interfere with the integrity of the data or safety of the subject.
Key Trial Info
Start Date :
May 13 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2029
Estimated Enrollment :
141 Patients enrolled
Trial Details
Trial ID
NCT06512194
Start Date
May 13 2025
End Date
May 1 2029
Last Update
May 23 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Vail Health Behavioral Health
Edwards, Colorado, United States, 81632