Actively Recruiting
Psilocybin for Hospitalized Patients with Treatment-resistant Depression
Led by University Hospital, Ghent · Updated on 2024-09-19
100
Participants Needed
1
Research Sites
136 weeks
Total Duration
On this page
Sponsors
U
University Hospital, Ghent
Lead Sponsor
F
Filament Health Corp.
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of this study is to determine the safety and feasibility of performing psilocybin-assisted psychotherapy in patients hospitalized for treatment-resistant depression.
CONDITIONS
Official Title
Psilocybin for Hospitalized Patients with Treatment-resistant Depression
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Diagnosis of moderate to severe major depressive disorder without psychotic features
- Failed to respond to 2 or more antidepressants at effective doses for at least 6 weeks
- Abstinent from alcohol and provide negative urine drug screen on dosing days
- Female participants must provide a negative pregnancy test on dosing days
- Medically stable based on lab tests, medical history, vital signs, and ECG
- QTcF c 450 ms for males or c 470 ms for females and PR-interval < 220 ms on ECG
- Have a partner willing to participate and cohabiting for at least 1 year
You will not qualify if you...
- Current or past diagnosis of major depressive episode with psychotic features
- Psychotic disorder (except brief substance-induced psychosis)
- Bipolar disorder type 1 or 2
- Drug or alcohol dependence syndrome
- Cluster B personality disorder
- PTSD diagnosis
- Family history of psychosis or bipolar disorder in a first-degree relative
- Active suicidal thoughts
- Depression caused by other medical conditions
- Recent stroke or myocardial infarction within 1 year
- Uncontrolled hypertension or significant arrhythmia within 1 year
- Uncontrolled insulin-dependent diabetes or epilepsy
- Significant biochemical or ECG abnormalities
- Current use of Lithium, Disulfiram, MAOIs, or certain enzyme inhibitors
- Prior vagal nerve stimulation or deep brain stimulation treatment
- Women of childbearing potential not using effective contraception
- Pregnant or breastfeeding women
- Unable to give informed consent
- Currently enrolled in another clinical trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Ghent University Hospital
Ghent, Oost-Vlaanderen, Belgium, 9000
Actively Recruiting
Research Team
C
Cisse Geleyn, dr.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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