UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030115 |
|---|---|
| Receipt number | R000034384 |
| Scientific Title | Internet-supported wake therapy for depression |
| Date of disclosure of the study information | 2017/12/01 |
| Last modified on | 2020/05/28 14:10:13 |
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Basic information
Public title
Internet-supported wake therapy for depression
Acronym
Internet-supported wake therapy for depression
Scientific Title
Internet-supported wake therapy for depression
Scientific Title:Acronym
Internet-supported wake therapy for depression
Region
| Japan |
Condition
Condition
Major depressive disorder
Bipolar disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of internet-supported wake therapy in patients with depression
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in HAM-D scores
Key secondary outcomes
BDI scores
Sleep EEG
Actigraph data
Sleep diary
Blood tests
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
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Internet-supported wake therapy (three cycles of sleep deprivation combined with bright light therapy)
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Diagnosed as having major depressive episode (DSM-5 criteria)
2) Can use an internet communication system at home
3) Can obtain written informed consent
Key exclusion criteria
1) With epileptic disorders
2) With cardiological diseases such as arrhythmias, coronary artery disease, and myocardinal disease
3) Taking three or more sleeping pills
4) Deemed unsuitable by the primary investigator for other reasons
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Masahiro |
| Middle name | |
| Last name | Suzuki |
Organization
Nihon University School of Medicine
Division name
Department of Psychiatry
Zip code
173-8610
Address
30-1 Oyaguchi-Kamicho, Itabashi-ku, Tokyo, Japan
TEL
03-3972-8111
suzuki.masahiro94@nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | Masahiro |
| Middle name | |
| Last name | Suzuki |
Organization
Nihon University School of Medicine
Division name
Department of Psychiatry
Zip code
173-8610
Address
30-1 Oyaguchi-Kamicho, Itabashi-ku, Tokyo, Japan
TEL
03-3972-8111
Homepage URL
suzuki.masahiro94@nihon-u.ac.jp
Sponsor or person
Institute
Department of Psychiatry, Nihon University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics committee of the Nihon University School of Medicine
Address
30-1 Oyaguchi-Kamicho, Itabashi-ku, Tokyo, Japan
Tel
03-3972-8111
med.itabashi.chiken@nihon-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
| 2017 | Year | 12 | Month | 01 | 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
Open public recruiting
Date of protocol fixation
| 2017 | Year | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 12 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 11 | Month | 25 | Day |
Last modified on
| 2020 | Year | 05 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034384
