Psilocybin administration for treatment-resistant depressio

Not Applicable

Recruiting

• Conditions: Treatment-resistant depression; depression; D061218

• Registration Number: JPRN-jRCTs031230351
• Lead Sponsor: chida Hiroyuki

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-09-21
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 12

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

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 < 60mL/min/1.73m2
AST > 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified