UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000052401 |
|---|---|
| Receipt number | R000059756 |
| Scientific Title | Examination of long-term safety and efficacy of psilocybin treatment for treatment-resistant depression: a 12-month follow-up study |
| Date of disclosure of the study information | 2023/10/16 |
| Last modified on | 2023/11/01 16:11:31 |
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Basic information
Public title
Examination of long-term safety and efficacy of psilocybin treatment for treatment-resistant depression: a 12-month follow-up study
Acronym
A 12-month follow-up study of psilocybin administration for treatment-resistant depression
Scientific Title
Examination of long-term safety and efficacy of psilocybin treatment for treatment-resistant depression: a 12-month follow-up study
Scientific Title:Acronym
A 12-month follow-up study of psilocybin administration for treatment-resistant depression
Region
| Japan |
Condition
Condition
Treatment-resitant Major Depressive Disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine the safety and efficacy of psilocybin therapy for treatment-resistant depression up to 12 months after completion of the "Examination of safety and efficacy of psilocybin treatment for treatment-resistant depression: a single-arm open-label trial ". In addition, multimodal MRI and TMS-EEG measurements will be used to explore the possibility of identifying the site of action, to evaluate other neurological changes and to search for biomarkers related to the long-term efficacy of psilocybin therapy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Montgomery-Asberg Depression Rating Scale (MADRS)
Key secondary outcomes
- 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)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
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 " Examination of safety and efficacy of psilocybin treatment for treatment-resistant depression: a single-arm open-label trial ". The Functional Magnetic Resonance Imaging Support Unit of RIKEN will perform scans using a 7-tesla MRI in accordance with RIKEN'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 the equipment, scans may be performed using a 3-tesla MRI at RIKEN, Keio University Hospital, or an outsourced laboratory (MRI Laboratory, Center for Evolutionary Cognitive Science, Graduate School of Arts and Sciences, University of Tokyo) in order to facilitate the research. The estimated time required is approximately 60 minutes per scan.
TMS-EEG test: Keio University Hospital
The TMS-EEG test will be performed 52 weeks (plus or minus 2 weeks) after the end of the second dosing session of the "Examination of safety and efficacy of psilocybin treatment for treatment-resistant depression: a single-arm open-label trial". 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 medical diagnostic purposes, but for the purpose of obtaining data on the exploratory endpoints. The estimated time required is approximately 180 minutes.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 59 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who completed "Examination of safety and efficacy of psilocybin treatment for treatment-resistant depression: a single-arm open-label trial"
Key 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
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Uchida |
| Middle name | |
| Last name | Hiroyuki |
Organization
Keio University School of Medicine
Division name
Department of Neuropsychiatry
Zip code
160-8582
Address
35, Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL
03-5363-3971
keio.psilocybin.research@gmail.com
Public contact
Name of contact person
| 1st name | Tani |
| Middle name | |
| Last name | Hideaki |
Organization
Keio University School of Medicine
Division name
Department of Neuropsychiatry
Zip code
160-8582
Address
35, Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL
03-5363-3971
Homepage URL
keio.psilocybin.research@gmail.com
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Keio University School of Medicine Institutional Review Board
Address
35, Shinanomachi, Shinjuku-ku, Tokyo, Japan
Tel
0353633503
med-rinri-jimu@adst.keio.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 10 | Month | 16 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2023 | Year | 08 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 10 | Month | 04 | Day |
Last modified on
| 2023 | Year | 11 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059756
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