Clinical TrialTreatment-Resistant Depression (TRD)PsilocybinPsilocybinCompleted

Psilocybin for Treatment-Resistant Depression

Randomised, parallel-group Phase II trial (n=30) comparing immediate vs delayed point-of-care psilocybin for treatment-resistant depression; single dosing with up to two repeat doses permitted for relapse.

Target Enrollment
30 participants
Study Type
Phase II interventional
Design
Randomized

Detailed Description

This randomised, parallel-group study evaluates feasibility, safety, and efficacy of point-of-care psilocybin in adults with treatment-resistant depression (MDD or bipolar II).

Participants receive a single dose of psilocybin and are assessed weekly for six weeks then biweekly to 18 weeks; those who relapse may receive up to two repeat doses. Primary outcome is feasibility; secondary outcomes include depressive symptom change and tolerability.

Safety monitoring includes tracking suicidal thoughts and behaviour, adverse events, vital signs, ECG and laboratory tests; exclusion criteria screen for personal or family history of psychosis and recent substance or medical risks.

Study Arms & Interventions

Immediate treatment

experimental

Participants commence psilocybin treatment immediately upon enrollment.

Interventions

  • Psilocybin
    via Oral• single dose• 3 doses total

    Single dose at point-of-care; participants who relapse may receive up to two repeat doses (total up to 3).

Delayed treatment

experimental

Participants commence psilocybin treatment two weeks after enrollment (delayed/waitlist comparator).

Interventions

  • Psilocybin
    via Oral• single dose• 3 doses total

    Single dose at point-of-care; participants who relapse may receive up to two repeat doses (total up to 3).

Participants

Ages
18 – 65
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • 1. Over the age of 18 years and under the age of 65;
  • 2. Diagnosed with major depressive disorder or bipolar II disorder by a healthcare provider;
  • 3. Experiencing a major depressive episode (MDE) without psychotic features as defined in DSM-5, duration of current episode at least 3 months;
  • 4. Have failed to respond to an adequate dose and duration of at least two guideline-concordant pharmacological treatments for the current MDE (per ATHF/MGH-ATRQ);
  • 5. Able to complete all protocol assessments and comply with study visits.

Exclusion Criteria

  • Exclusion Criteria:
  • Current or past history of bipolar I disorder, schizophrenia, psychotic disorder, delusional disorder, paranoid personality disorder, or schizoaffective disorder (assessed by structured interview);
  • First-degree history of schizophrenia or any psychotic disorders, including bipolar disorder with psychotic features;
  • Currently experiencing symptoms of hypomania or mania (YMRS total score >12);
  • History of a hypomanic or manic episode in the past 3 months;
  • History of substance use and/or alcohol use disorder of moderate severity or greater in past 3 months;
  • Lifetime history of substance use disorder with a hallucinogen; lifetime history of substance-induced psychosis;
  • Currently experiencing psychotic symptoms as part of an MDE;
  • Exposure to psilocybin or any other psychedelic in the past 12 months prior to screening and/or during the current MDE;
  • Uncontrolled or insulin-dependent diabetes; seizure disorder;
  • Any personal circumstances or behaviour judged incompatible with safe exposure to psilocybin;
  • Women who are pregnant, nursing, or planning a pregnancy; refusal to use effective contraception throughout participation;
  • Recent stroke (<1 year) or myocardial infarction (<1 year); uncontrolled hypertension (BP >140/90 mmHg) or clinically significant arrhythmia within 1 year;
  • Positive urine drug screen for illicit drugs at screening, 1 week prior to treatment, or during trial;
  • Current enrolment in any investigational drug/device study or interventional depression study within 30 days of screening;
  • Abnormal and clinically significant physical exam, vital signs, ECG, or laboratory tests at screening; any other major concurrent illness that may interfere with study or pose risk.

Study Details

Locations

Canadian Rapid Treatment Centre of Excellence (CRTCE) — Mississauga, Ontario, Canada

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