UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015249 |
|---|---|
| Receipt number | R000017733 |
| Scientific Title | The development of treatment using the connectivity neurofeedback for patients with affective disorders |
| Date of disclosure of the study information | 2014/09/25 |
| Last modified on | 2024/04/04 19:55:51 |
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Basic information
Public title
The development of treatment using the connectivity neurofeedback for patients with affective disorders
Acronym
The development of treatment using the connectivity neurofeedback for patients with affective disorders
Scientific Title
The development of treatment using the connectivity neurofeedback for patients with affective disorders
Scientific Title:Acronym
The development of treatment using the connectivity neurofeedback for patients with affective disorders
Region
| Japan |
Condition
Condition
Major depressive disorder (monopolar depression) and bipolar disorder(bipolar I disorder and bipolar II disorder)
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
A main purpose of this clinical trial is to evaluate safety and efficacy, including antidepressant effect and prefrontal cognitive enhancement, of fMRI neurofeedback applied to major depressive episode.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Assessment
Primary outcomes
1) Hamilton Depression Rating Scale (Ham-D) 17items and 24items
2) Beck Depression Inventry II (BDI-II)
3) Self-rating Depression Scale (SDS)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Cluster
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Behavior,custom |
Interventions/Control_1
fMRI neurofeedback
Connectivity-based neurofeedback using a 3T fMRI apparatus
Interventions/Control_2
Duration of intervention: 1 week to 2 weeks
Dose of intervention: 6 to 10 sessions per day
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. DSM-IV-TR diagnosis of major depressive disorder or bipolar disorder(BPI or II)
2. Current diagnosis of major depressive episode
3. Normal visual acuity
4. Aged 20-65 years-old, outpatients, self-sustained ADL
5. Capability of informed consent
Key exclusion criteria
1. Implanted cardiac pacemaker
2. Surgical aneurysm clips
3. Neurostimulator
4. Implanted pumps
5. Metal fragments in body/eyes
6. Tattoos or permanent eyeliner (if ink contains metallic specks)
7. Treatment history of ECT
8. Diagnosis of neurological disorders (including epilepsy), substance dependence, or
significant cardiac disease
9. History of neurological disorders (including epilepsy), substance dependence, or head injury with loss of consciousness
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Jun |
| Middle name | |
| Last name | Miyata |
Organization
Kyoto University Graduate School of Medicine
Division name
Department of Psychiatry
Zip code
606-8507
Address
54 Shogoin-Kawara-cho Sakyo-ku Kyoto
TEL
075-751-3386
miyata10@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Jun |
| Middle name | |
| Last name | Miyata |
Organization
Kyoto University Graduate School of Medicine
Division name
Department of Psychiatry
Zip code
606-8507
Address
54 Shogoin-Kawara-cho Sakyo-ku Kyoto
TEL
075-751-3386
Homepage URL
miyata10@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Advanced Telecommunications Research Institute International(ATR)
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address
53, Kawaramachi-shogoin, Sakyo-ku, Kyoto 606-8507, Japan
Tel
075-753-4680
ethcomkuhp@kyoto-u.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
| 2014 | Year | 09 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
36
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
Main results already published
Date of protocol fixation
| 2014 | Year | 09 | Month | 19 | Day |
Date of IRB
| 2014 | Year | 09 | Month | 19 | Day |
Anticipated trial start date
| 2015 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2024 | Year | 03 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 09 | Month | 25 | Day |
Last modified on
| 2024 | Year | 04 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017733
