Treatment-resistant depression depression
Conditions
Interventions
Psilocybin therapy (1 preparation session
1 medication session, Psilocybin 10 mg or 25 mg orally
2 reviewing sessions) for a total of 2 courses.
D011562
psilocybin
Sponsors
Uchida Hiroyuki
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Those who meet the criteria for depression according to Structured Clinical Interview for DSM-5 Disorders SCID-5-RV (ResearchVersion) Japanese Version 2. Male and female outpatients between the ages of 20 and 60 at the time of registration. 3. Inadequate response to 2 or more antidepressants at approved doses for 6 weeks or more for the current depressive episode 4. A Montgomery-Asberg Depression Rating Scale (MADRS) total score of 20 or higher at the time of screening 5. Being capable of providing informed consent confirmed with scores above 70% in the following four items: understanding, appreciation, reasoning, and the ability to express a choice in the MacArthur Competence Assessment Tool (MacCAT) 6. Written consent being provided by study participant
Exclusion criteria
Exclusion criteria: 1. Having previously received psilocybin for the treatment of depression 2. Depression with psychotic features according to the diagnostic criteria of the DSM-5 3. Presence of other comorbidities according to the diagnostic criteria of the DSM-5 4. Presence of neurodevelopmental disorders according to the diagnostic criteria of the DSM-5 5. A history of schizophrenia spectrum and other psychotic disorders according to the diagnostic criteria of the DSM-5 in any of blood parents, children, and siblings 6. A history of self-harm or suicidal attempts 7. Taking a monoamine oxidase (MAO) inhibitor or uridine diphosphate glucuronosyltransferase enzyme modulator 8. Taking 5-hydroxytryptophan or St. John's wort 9. Being pregnant, breastfeeding, or hoping to become pregnant 10. A history of epilepsy or seizures 11. A history of cerebrovascular disease 12. High blood pressure (systolic pressure 160 mmHg or more, diastolic pressure 100 mmHg or more) 13. A history of ocular trauma 14. Receiving electroconvulsive therapy within 3 months prior to enrollment 15. Substance-related disorders (excluding nicotine and caffeine) within 6 months 16. Positive urine screening for dependent substances (except for those who are positive for drugs taken for treatment) 17. Having a metallic substance in the body or having a pacemaker 18. Size of the head, neck and body are not suitable for MRI scanners 19. Having tattoos that are larger than one point (including tattoos and art make-up) 20. A high degree of claustrophobia 21. Significant deformity of brain structure (including congenital and traumatic) 22. At the time of registration, any of the following abnormal laboratory values eGFR 60IU/L ALT > 84IU/L (males), ALT > 46IU/L (females) 23. Participated in another clinical trial within 12 weeks prior to enrollment (limited to those with invasion/intervention) 24. Those deemed unsuitable as research subjects by the principal investigator, etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of completers (those who completed 2 courses of psilocybin therapy) | — |
Secondary
| Measure | Time frame |
|---|---|
| - Adverse events - Severity of mood symptoms assessed with Montgomery-Asberg Depression Rating Scale - Severity of mood symptoms assessed with 24-item Hamilton Depression Rating Scale - Severity of mood symptoms assessed with Quick Inventory of Depressive Symptomatology Self-Report - Severity of obsessive symptoms assessed with YBOCS - Cognitive function measured with Repeatable Battery for the Assessment of Neuropsychological Status - Cognitive function measured with Letter Number Sequencing Test - Cognitive function measured with Stroop - Cognitive function measured with Neuropsychological Screening Test - Cognitive function measured with Trail Making Test - Degree of suicidal ideation measured with Columbia-Suicide Severity Rating Scale - Quality of sleep measured with Pittsburgh Sleep Quality Index - Quality of sleep measured with Athens Insomnia Index - Degree of emotional control measured with Emotion Regulation Questionnaire - Degree of resilience measured with Resilience Scale - Degree of optimism measured with Life Orientation Test-Revised - Degree of emotional control measured with sense of coherence measured with Sense of Coherence Scale | — |
Contacts
Public ContactHiroyuki Uchida
Keio University Hospital
Outcome results
None listed