UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054895 |
|---|---|
| Receipt number | R000062724 |
| Scientific Title | Enhancing antidepressant effects of Repetitive transcranial magnetic stimulation by bright light exposure |
| Date of disclosure of the study information | 2024/07/07 |
| Last modified on | 2025/07/09 17:44:54 |
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Basic information
Public title
Enhancing antidepressant effects of Repetitive transcranial magnetic stimulation by bright light exposure
Acronym
Enhancing antidepressant effects of Repetitive transcranial magnetic stimulation by bright light exposure
Scientific Title
Enhancing antidepressant effects of Repetitive transcranial magnetic stimulation by bright light exposure
Scientific Title:Acronym
Enhancing antidepressant effects of Repetitive transcranial magnetic stimulation by bright light exposure
Region
| Japan |
Condition
Condition
major depressive disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate whether bright light exposure during rTMS for depressive episodes enhances the effects of rTMS on depressive symptoms, cognitive function, and sleep problem
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in depressive symptoms questionnaire scores pre- and post-treatment
Key secondary outcomes
Change in insomnia symptoms and change in time production tasks pre- and post-treatment
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Bright light exposure is performed at the same time as the rTMS session.
Interventions/Control_2
Low-intensity light exposure at the same time as the rTMS session.
Interventions/Control_3
Bright light exposure for the same length of time before the rTMS session.
Interventions/Control_4
Bright light exposure for the same length of time after the rTMS session.
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Inpatients receiving rTMS for more than moderate depression that is not responding to pharmacotherapy
Key exclusion criteria
1) Patients with photodermatosis
2) Patients judged to be inappropriate by the principal investigator
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | daisuke |
| Middle name | |
| Last name | hayashi |
Organization
National Center Hospital, National Center of Neurology and Psychiatry
Division name
Department of Psychiatry
Zip code
187-8551
Address
4-1-1 Ogawa-Higashi, Kodaira, Tokyo
TEL
042-341-2711
dhayashi@ncnp.go.jp
Public contact
Name of contact person
| 1st name | Kentaro |
| Middle name | |
| Last name | Nagao |
Organization
National Institute of Mental Health, National Center of Neurology and Psychiatry
Division name
Department of Sleep-Wake Disorders
Zip code
187-8553
Address
4-1-1 Ogawa-Higashi, Kodaira, Tokyo
TEL
042-346-2014
Homepage URL
knagao@ncnp.go.jp
Sponsor or person
Institute
National Center of Neurology and Psychiatry
Institute
Department
Personal name
Funding Source
Organization
National Center of Neurology and Psychiatry
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Center of Neurology and Psychiatry Ethics Committee
Address
4-1-1 Ogawa-Higashi, Kodaira, Tokyo
Tel
042-341-2711
rinri-jimu@ncnp.go.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
| 2024 | Year | 07 | Month | 07 | 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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 03 | Month | 31 | Day |
Date of IRB
| 2024 | Year | 05 | Month | 17 | Day |
Anticipated trial start date
| 2024 | Year | 07 | Month | 08 | Day |
Last follow-up date
| 2029 | Year | 03 | 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
| 2024 | Year | 07 | Month | 05 | Day |
Last modified on
| 2025 | Year | 07 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062724
