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

This randomised, double-blind, controlled trial (n=60) will examine the rapid antidepressant effects of psilocybin (5mg) compared to ketamine (50mg) in patients with treatment-resistant depression (TRD).

Sponsored by the National Institute of Mental Health in the Czech Republic, the trial aims to evaluate the antidepressant responses 24 hours after a single dose of either psilocybin or ketamine, assuming both drugs will have similar effects. Secondary objectives include comparing the duration of antidepressant effects, response rates, and safety profiles of the two substances.

The trial includes 60 patients aged 18-65 diagnosed with treatment-resistant moderate to severe depression. Patients must have failed at least two adequate treatments or demonstrated intolerance to treatments. The trial involves a 24-hour evaluation period post-dose and subsequent assessments up to 12 weeks. Exclusion criteria include serious psychiatric comorbidities, suicidal tendencies, substance dependencies, and certain medical conditions. The trial will take place solely in the Czech Republic, with an estimated duration of three years.

Topic Treatment-Resistant Depression Depression
Compound Ketamine Psilocybin
Country Czech Republic
Visit trial
Status Recruiting
Results Published No
Start date 05 March 2019
End date 31 December 2024
Phase Phase II
Design Blinded
Type Interventional
Generation First
Participants 60
Sex All
Age 18- 65
Therapy No

Trial Details

This ongoing clinical trial, conducted in Czechia, compares the antidepressant effects of psilocybin and ketamine in treating pharmaco-resistant depression. It involves 60 participants, aged 18-65, and assesses the drugs' efficacy using the MADRS scale. The study also evaluates the duration of antidepressant effects, response rates, safety profiles, and more. It's a randomised, double-blind, controlled trial expected to last three years.

NCT Number 2018-004480-31

Sponsors & Collaborators

National Institute of Mental Health
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Data attribution

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