Examination of long-term safety and efficacy of psilocybin treatment for treatment-resistant depression: a 12-month follow-up study
Not Applicable
- Conditions
- Treatment-resitant Major Depressive Disorder
- Registration Number
- JPRN-UMIN000052401
- Lead Sponsor
- Keio University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 12
Inclusion Criteria
Not provided
Exclusion Criteria
1. Metallic substances implanted in the body or pacemakers 2. Head, neck, or body size not suitable for MRI scanner 3. Tattoos (including tattoos and art makeup) larger than a single point 4. Severe claustrophobia
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Montgomery-Asberg Depression Rating Scale (MADRS)
- Secondary Outcome Measures
Name Time Method - Adverse events associated with psilocybin administration - 24-item Hamilton Depression Rating Scale (HDRS) - Quick Inventory of Depressive Symptomatology Self-Report (QIDS-SR) - Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) - Japanese version of the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) - Letter-Number Sequencing (LNS) - Stroop Neuropsychological Screening Test (SNST) - Trail Making Test (TMT) - Columbia-Suicide Severity Rating Scale (C-SSRS) - Pittsburgh Sleep Quality Index (PSQI) - Athens Insomnia Index (AIS) - Emotion Regulation Questionnaire (ERQ) - Resilience Scale (RS) - Life Orientation Test-Revised (LOT-R) - Sense of Coherence Scale (SOC)