Psilocybin administration for treatment-resistant depression

JRCT ID: jRCTs031230351

Registered date:21/09/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Treatment-resistant depression
• Date of first enrollment: 21/09/2023
• Target sample size: 12
• Study type: Interventional
• Intervention(s): Psilocybin therapy (1 preparation session; 1 medication session, Psilocybin 10 mg or 25 mg orally; 2 reviewing sessions) for a total of 2 courses.

Outcome(s)

• Primary Outcome: Proportion of completers (those who completed 2 courses of psilocybin therapy)

Secondary Outcome

- 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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 60age old
• Gender: Both

Include 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

Exclude 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.

Related Information

• Primary Sponsor: Uchida Hiroyuki
• Source(s) of Monetary Support: SENSHIN Medical Research Foundation,Japan Agency for Medical Research and Development (AMED)