Actively Recruiting
Psilocybin-Assisted Psychotherapy for Treatment-Resistant Depression: A Randomized Phase II Trial Comparing One Versus Two Psychedelic Doses of Psilocybin
Led by University Health Network, Toronto · Updated on 2024-04-02
92
Participants Needed
1
Research Sites
26 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
Researchers are evaluating whether one or two doses of psilocybin, combined with psychotherapy, can better relieve depressive symptoms in adults with treatment-resistant depression (TRD). This phase II trial aims to compare the effectiveness, safety, and tolerability of a single dose versus two doses of psilocybin. The study also explores effects on suicidality, quality of life, functioning, cognition, and the duration of symptom improvement over six months. Participants receive either two doses of 25 mg psilocybin or one low dose followed by a 25 mg dose, both alongside psilocybin-assisted psychotherapy. Each dosing session involves support from specialized therapists for 6 to 8 hours. The study includes an 8-week treatment period followed by a six-month observational follow-up to monitor lasting effects and side effects. During the study, participants undergo regular assessments including depression rating scales, safety monitoring for side effects and suicidality, and cognitive testing. Researchers track changes from baseline through Week 8 and throughout six months. Safety is closely monitored during dosing days and follow-up visits. Total participation lasts approximately six months after initial treatment.
CONDITIONS
Brief 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
- Must sign and date the informed consent form
- Willing to comply with all study procedures
- Able to read and communicate in English sufficiently for consent and questionnaires
- Diagnosed with major depressive disorder currently experiencing a moderate to severe major depressive episode
- MADRS score greater than 21
- Have not responded to at least two adequate antidepressant treatments
- Able to take oral medication
- If capable of becoming pregnant, must use highly effective contraception before and during study
- If capable of impregnating a partner, must use effective contraception during study
- Willing to taper off certain psychiatric medications 1 month before baseline, if safe
- Willing to avoid other psychotherapy during the 8-week trial, if safe
- Have a caregiver to stay with them for 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 in past 3 months or hallucinogen use disorder
- Major neurocognitive disorder
- Active suicidal ideation or recent suicide attempts requiring hospitalization
- Contraindications to psilocybin such as drug allergy, recent stroke, uncontrolled hypertension, heart conditions, or severe kidney or liver impairment
- Pregnant, breastfeeding, or intending to become pregnant during study
- Use of other investigational drugs within 30 days before baseline
- Receiving brain stimulation therapy within 30 days before baseline or during trial
- Recent changes to psychiatric medications within 30 days before trial
- Lifetime diagnosis of schizophrenia-spectrum, bipolar I or II, or certain personality disorders
- First-degree relative with schizophrenia-spectrum, bipolar I or II, or psychotic disorder
- Uncontrolled seizure disorder or recent seizure
- Prolonged QTc or related heart rhythm problems
- Use of classic psychedelic drugs within 6 months prior
- Other serious physical illnesses affecting study safety or results
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 8 weeks
Participants receive one or two doses of psilocybin combined with psychotherapy. Each dosing session involves support from two specialized therapists for 6-8 hours.
1 to 2 dosing visits, plus additional psychotherapy sessions during the treatment period
Duration - 6 months
Participants are monitored for safety, tolerability, and longer-term effects on depression symptoms, quality of life, and cognitive function.
Regular follow-up visits during the 6-month period
Trial Site Locations
Total: 1 location
1
Toronto Western Hospital
Toronto, Ontario, Canada, M5T 2S8
Actively Recruiting
Research Team
D
Danica Johnson, BScH
Z
Zoe Doyle, RN
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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