Psilocybin versus ketamine – fast acting... — Clinical Trial Details

Participants

Ages

18 – 65

Sexes

Male & Female

BMI

Psychosis History

Inclusion Criteria

1) Men and women aged 18–65.
2) Diagnosis of moderate to severe depressive episode without psychotic symptoms (ICD‑10 F32.1–2 or F33.1–2) and MADRS score > 20.
3) Duration of current depressive episode ≥3 months and ≤2 years.
4) Treatment‑resistant depression defined as failure of ≥2 and ≤4 adequate treatments (or specified combinations/intolerances) during the current episode.
5) Ability to understand protocol and attend all visits.
6) Have a designated caregiver able to be in contact 5× weekly.
7) Participants of childbearing potential must agree to reliable contraception during the study.

Exclusion Criteria

1) Serious psychiatric comorbidity (Axis I MINI, ICD‑10 F0x–F99x, as assessed clinically).
2) Current depressive episode with psychotic symptoms (ICD‑10 F32.3, F33.3).
3) MADRS suicidality item (item 10) > 4.
4) Suicide attempt within the last 6 months.
5) Current episode duration > 2 years.
6) Current drug or alcohol dependence (except tobacco) unless abstinent >2 years.
7) Claustrophobia or inability to undergo MRI.
8) Pregnancy, breastfeeding or plan to become pregnant within 3 months.
9) Intracranial hypertension, pulmonary hypertension, uncontrolled arterial hypertension (BP >150/100 mmHg).
10) Recent stroke or myocardial infarction (last 6 months); heart failure.
11) Untreated or decompensated hyperthyroidism.
12) Glaucoma.
13) Severe respiratory failure or acute respiratory depression.
14) History of seizures.
15) Any other serious somatic disease posing risk with BP rise (assessed clinically).
16) Pacemaker or MR‑incompatible metal implants.
17) Regular use of medications that could interact with psilocybin (assessed by investigator).
18) Current MAOI use (must be discontinued with taper ≥14 days prior to dosing).
19) Prior experience with psilocybin, hallucinogenic mushrooms or ketamine permitted in ≤10% of patients, not within past 12 months or current episode.
20) Recent antidepressant/antipsychotic or 5‑HT2A‑antagonist drugs unless tapered ≥7 days prior to dosing.
21) ECT in previous 3 months; rTMS in previous 4 weeks.
22) Daily benzodiazepine use > diazepam 10 mg equivalent.
23) Allergy to study drug components.

Company

Product

Legal

Psilocybin versus ketamine – fast acting antidepressant strategies in treatment-resistant depression

Detailed Description

Study Protocol

Preparation

Dosing

Locations

Integration

Study Arms & Interventions

Psilocybin 25 mg

Interventions

Ketamine 250 mg

Interventions

Midazolam 5 mg

Interventions

Participants

Inclusion Criteria

Exclusion Criteria

Study Details