pharmaco-resistant depression
Conditions
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
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of fast antidepressant effects of psilocybin versus ketamine. | — |
Secondary
| Measure | Time 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