Status:
UNKNOWN
Psilocybin Versus Ketamine in Treatment-Resistant Depression
Lead Sponsor:
National Institute of Mental Health, Czech Republic
Collaborating Sponsors:
Czech Health Research Council
Czech Clinical Research Infrastructure Network
Conditions:
Treatment Resistant Depression
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief 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 antidepr...
Detailed Description
The main aim of the study is to verify the efficacy and safety of a single dose of psilocybin 20 mg in the treatment of TRD in adults in a randomized clinical trial with active comparator ketamine 200...
Eligibility Criteria
Inclusion
- Men and women aged 18-65
- Diagnosis of moderate to severe depressive disorder without psychotic symptoms - ICD-10 criteria F32.1-2 or F33.1-2 and at the same time MADRS score \> 20
- The duration of the current depressive episode is at least 3 months and maximum 2 years
- Treatment-resistant depression defined as:
- Failure of at least 2 and at most 4 adequate treatments (6 weeks of full therapeutic dose of antidepressant or adequate non-pharmacological treatment - e.g. psychotherapy, neurostimulation treatment, phototherapy, etc.) within the current depressive episode, using at least 2 types of antidepressants with different pharmacological mechanisms of action (augmentation is taken as a second treatment) or
- Intolerance of 2 different treatments and 1 adequate treatment or
- Intolerance of 3 different antidepressant treatments.
- Ability to understand the study protocol and to be able to complete all study visits and examinations as defined per protocol.
- Participants in a clinical trial of childbearing potential must agree to the use of prescribed contraceptive methods for the duration of the study
Exclusion
- Severe psychiatric comorbidity (axis I MINI, ICD-10 F0.X - F99.X, the intensity of the disorder will be clinically assessed by the study clinician)
- The current depressive phase is severe with psychotic symptoms (ICD-10: F32.3, F33.3)
- MADRS suicidality score (item 10)\> 4
- Duration of the current depressive episode longer than 2 years
- Current drug or alcohol dependence (ICD-10: F17.x) with the exception of tobacco and with the exception of abstinence lasting more than 2 years
- Claustrophobia, inability to undergo MR examination
- Pregnancy or breast-feeding or plan to become pregnant within the next 12 months
- Intracranial hypertension, pulmonary hypertension, uncorrected arterial hypertension (BP\> 150/100 mmHg)
- Condition after stroke, myocardial infarction in the last 6 months
- Heart failure
- Untreated or decompensated hyperthyroidism
- Glaucoma
- Severe respiratory failure or acute respiratory depression
- History of seizures
- Other serious somatic disease or any other circumstance in which a significant increase in blood pressure would pose a serious threat to health (to be assessed by the study clinician)
- Pacemaker
- Metal implants made of MR incompatible materials
- Regular use of medication that could interact with psilocybin (to be assessed by the investigator)
- Regular use of antipsychotics with 5-HT2A receptor antagonist activity or discontinuation of their use for less than 14 days (eg risperidone, olanzapine, clozapine, quetiapine, ziprasidone)
- Current use of monoamine oxidase inhibitors (MAOIs)
- Previous experience with psilocybin, hallucinogenic mushrooms or ketamine is possible in a maximum of 10% of patients. This experience must not be during the last 12 months or during the current depressive episode.
- Recent use of antidepressants with a direct antagonistic effect on 5-HT2A receptors such as SARI and tetracyclic antidepressants (eg trazodone, mirtazapine, mianserin) or discontinuation of their use for less than 14 days
- Electroconvulsive therapy in the previous 3 months
- Daily use of benzodiazepine anxiolytics higher than the equivalent of 10 mg diazepam
- Allergy to any of the components of study drugs
Key Trial Info
Start Date :
May 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2025
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT05383313
Start Date
May 1 2021
End Date
April 30 2025
Last Update
May 20 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
National Institute of Mental Health
Klecany, Czechia, 250 67