MedTrace Logo

Psilocybin Versus Ketamine in Treatment-Resistant Depression

NCT05383313 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2022-05-20

No results posted yet for this study

Summary

The main goal is to compare the antidepressant effects of psilocybin and ketamine in patients with TRD versus the antidepressant inactive substance midazolam. The primary endpoint will be the antidepressant effect on the Montgomery- Asberg Depression Rating Scale (MADRS) 24 hours after treatment, the key secondary endpoints being the duration of antidepressant effect, the number of responses and remissions, and the time to standard antidepressant treatment during 3 months of observation. The exploratory part of the study aims to monitor changes in the functional brain states using simultaneous EEG / fMRI, before treatment versus 1 day and 1 week after. Based on literature data and recent data from healthy volunteers who participated in a previous study with psilocybin, the investigator will correlate antidepressant effects of drugs (using psychometric scales and reactions to emotionally salient stimuli (eye tracker)) with entropy and functional connectivity measures. Finally the investigator will explore the role of plasmatic neurobiological biomarkers in depression (BDNF, prolactin, ACTH and oxytocin).

Conditions

Interventions

DRUG

Psilocybin

Effect of psilocybin on treatment-resistant depression

DRUG

Ketamine Hydrochloride

Effect of ketamine on treatment-resistant depression

DRUG

Midazolam Ph. Eur 9.0

Effect of midazolam on treatment-resistant depression

Sponsors & Collaborators

  • Czech Health Research Council

    collaborator UNKNOWN

  • Czech Clinical Research Infrastructure Network

    collaborator UNKNOWN

  • National Institute of Mental Health, Czech Republic

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-01
Primary Completion
2025-04-30
Completion
2025-04-30

Countries

  • Czechia

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05383313 on ClinicalTrials.gov