Actively Recruiting
Psilocybin-Assisted Psychotherapy for Treatment-Resistant Depression: Comparing One Versus Two Doses of Psilocybin
Led by University Health Network, Toronto · Updated on 2024-04-02
92
Participants Needed
1
Research Sites
234 weeks
Total Duration
On this page
Sponsors
U
University Health Network, Toronto
Lead Sponsor
C
Centre for Addiction and Mental Health
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of this study is to see if one or two doses of psilocybin is more effective in relieving depressive symptoms in patients with treatment-resistant depression (TRD). Researchers also want to know if a second dose of psilocybin is safe and well-tolerated. This study will see if psilocybin is effective, safe, and well-tolerated by tracking changes in depressive symptoms, suicidality, and side effects. This study will also see if a second dose of psilocybin has an effect on quality of life, functioning, cognition (thinking, reasoning, remembering), and how long depressive symptoms improve (or worsen) after psilocybin is administered.
CONDITIONS
Official Title
Psilocybin-Assisted Psychotherapy for Treatment-Resistant Depression: Comparing One Versus Two Doses of Psilocybin
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 18 to 65 years old.
- Able to provide informed consent.
- Willing to sign and date the consent form.
- Willing to follow all study procedures.
- Able to read and communicate in English well enough to understand consent and questionnaires.
- Diagnosed with major depressive disorder, currently experiencing a moderate to severe major depressive episode without psychotic features.
- Depression severity score (MADRS) greater than 21.
- Have not responded to at least two adequate antidepressant trials.
- Able to take oral medication.
- Individuals capable of becoming pregnant must use highly effective contraception for at least 1 month before screening and during the study, with monthly check-ins.
- Individuals capable of making a partner pregnant must use effective contraception throughout the study.
- Willing to taper off certain psychiatric medications at least 1 month before baseline, if safe.
- Willing to avoid additional psychotherapy during the 8-week trial, if safe.
- Have a caregiver able to stay with them for at least 24 hours after treatment sessions.
- Agree to follow lifestyle considerations throughout the study.
You will not qualify if you...
- History of mania, hypomania, or psychosis.
- Current symptoms of mania, hypomania, or mixed features.
- Substance, cannabis, or alcohol use disorder within past 3 months or lifetime hallucinogen use disorder.
- Major neurocognitive disorder.
- Active suicidal thoughts requiring inpatient treatment or recent suicide attempts within 3 months.
- Contraindications to psilocybin, including drug allergy, recent stroke, uncontrolled hypertension, recent heart attack, serious heart conditions, or moderate to severe kidney or liver impairment.
- Pregnant, breastfeeding, or intending to become pregnant during the study.
- Use of another investigational drug or intervention within 30 days before baseline.
- Receiving brain stimulation therapies currently or within 30 days before baseline.
- Changes in psychiatric medications within 30 days before trial entry, except as needed.
- Diagnosed with schizophrenia-spectrum disorder, obsessive-compulsive disorder, psychotic disorder, bipolar I or II disorder, paranoid personality disorder, or borderline personality disorder.
- First-degree relative with schizophrenia-spectrum disorder, psychotic disorder, or bipolar I or II disorder.
- Uncontrolled seizure disorder or seizure within past 12 months.
- Prolonged QTc or related heart rhythm risks.
- Use of classic psychedelics in past 6 months.
- Other major physical illnesses that may interfere with study or pose health risks.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Toronto Western Hospital
Toronto, Ontario, Canada, M5T 2S8
Actively Recruiting
Research Team
D
Danica Johnson, BScH
CONTACT
Z
Zoe Doyle, RN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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