Examination of long-term safety and efficacy of psilocybin treatment for treatment-resistant depression: a 12-month follow-up study

Examination of long-term safety and efficacy of psilocybin treatment for treatment-resistant depression: a 12-month follow-up study - A 12-month follow-up study of psilocybin administration for treatment-resistant depression

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000052401

Enrollment

Registered

2023-10-16

Start date

2025-01-27

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Treatment-resitant Major Depressive Disorder

Interventions

MRI scan: RIKEN Brain Science Institute The study will be conducted 52 weeks (plus or minus 2 weeks) after the end of the second dosing session of &quot

Examination of safety and efficacy of psilocybin treatment for treatment-resistant depression: a single-arm open-label trial &quot

. The Functional Magnetic Resonance Imaging Support Unit of RIKEN will perform scans using a 7-tesla MRI in accordance with RIKEN&#39

s contract study system. The MRI examination is not for diagnostic purposes, but for the purpose of obtaining data regarding the exploratory endpoints. Depending on the availability and maintenance of

Examination of safety and efficacy of psilocybin treatment for treatment-resistant depression: a single-arm open-label trial&quot

. Depending on the availability of equipment, the TMS-EEG test may be conducted at an outside contract laboratory (Yoyogi Mental Laboratory Clinic, Shinjuku). The TMS-EEG test is not intended for medi

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients who completed "Examination of safety and efficacy of psilocybin treatment for treatment-resistant depression: a single-arm open-label trial"

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Montgomery-Asberg Depression Rating Scale (MADRS)	—

Secondary

Measure	Time frame
- 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)	—

Measure

Time frame

- 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)

—

Countries

Japan

Contacts

Public ContactTani Hideaki

Keio University School of Medicine Department of Neuropsychiatry

keio.psilocybin.research@gmail.com03-5363-3971

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026