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

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-515899-13-00
Acronym
PSIKET_001CZE
Enrollment
60
Registered
2024-11-21
Start date
2024-11-21
Completion date
Unknown
Last updated
2025-11-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

pharmaco-resistant depression

Brief summary

Evaluation of fast antidepressant effects of psilocybin versus ketamine.

Detailed description

Duration of the antidepressant effect of psilocybin, ketamine and midazolam using the MADRS scale during 2 weeks of inpatient stay, Duration of the antidepressant effect of psilocybin, ketamine and midazolam after termination of inpatient stay using the MADRS scale., Duration of the antidepressant effect of a single application of psilocybin, ketamine and midazolam using the QIDS scale., Comparison of response rates (50% reduction in MADRS scale) and remissions (MADRS ≤ 10) following psilocybin, ketamine and midazolam treatment, Time to reoccurrence of the depressive symptoms within 12 weeks (3 months) after treatment with psilocybin, ketamine and midazolam., Safety profile of study drug: a) acute (vital signs (BP/HR), BPRS, psilocin levels) b) longterm (BPRS, PSQ a Persistent effects scale)

Interventions

None listed

Sponsors

Narodni Ustav Dusevniho Zdravi
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
Evaluation of fast antidepressant effects of psilocybin versus ketamine.

Secondary

MeasureTime frame
Duration of the antidepressant effect of psilocybin, ketamine and midazolam using the MADRS scale during 2 weeks of inpatient stay, Duration of the antidepressant effect of psilocybin, ketamine and midazolam after termination of inpatient stay using the MADRS scale., Duration of the antidepressant effect of a single application of psilocybin, ketamine and midazolam using the QIDS scale., Comparison of response rates (50% reduction in MADRS scale) and remissions (MADRS ≤ 10) following psilocybin, ketamine and midazolam treatment, Time to reoccurrence of the depressive symptoms within 12 weeks (3 months) after treatment with psilocybin, ketamine and midazolam., Safety profile of study drug: a) acute (vital signs (BP/HR), BPRS, psilocin levels) b) longterm (BPRS, PSQ a Persistent effects scale)

Countries

Czechia

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026