UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001369 |
|---|---|
| Receipt number | R000001652 |
| Scientific Title | Changes in sleep phases associated with alleviation of depressive symptoms using polysomnography after repetitive transcranial magnetic stimulation |
| Date of disclosure of the study information | 2008/09/10 |
| Last modified on | 2010/10/02 12:07:32 |
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Basic information
Public title
Changes in sleep phases associated with alleviation of depressive symptoms using polysomnography after repetitive transcranial magnetic stimulation
Acronym
Changes in sleep phases in depression after repetitive transcranial magnetic stimulation
Scientific Title
Changes in sleep phases associated with alleviation of depressive symptoms using polysomnography after repetitive transcranial magnetic stimulation
Scientific Title:Acronym
Changes in sleep phases in depression after repetitive transcranial magnetic stimulation
Region
| Japan |
Condition
Condition
Major depressive disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We aim to investigate changes in sleep phases associated with alleviation of depressive symptoms using polysomnography before and after repetitive transcranial magnetic stimulation.
Basic objectives2
Others
Basic objectives -Others
We aim to investigate changes in sleep phases with polysomnography.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
We will evaluate changes in sleep phases associated with therapeutic efficacy of repetitive transcranial magnetic stimulation.
Key secondary outcomes
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
| Device,equipment |
Interventions/Control_1
We will stimulate left dorsolateral prefrontal cortex with high-frequency over 3 weeks.
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
| 25 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who meet with DSM criteria for major depressive disorder.
Key exclusion criteria
Exclusion criteria includes severe medical illness, a history of convulsive disorder, and severe suicide idea.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinsuke Kitou |
Organization
Kyorin University School of Medicine
Division name
Department of Neuropsychiatry
Zip code
Address
6-20-2 Shinkawa, Mitaka, Tokyo 181-8611, Japan
TEL
0422-47-5511
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shinsuke Kitou |
Organization
Kyorin University School of Medicine
Division name
Department of Neuropsychiatry
Zip code
Address
6-20-2 Shinkawa, Mitaka, Tokyo 181-8611, Japan
TEL
0422-47-5511
Homepage URL
psychiat@kyorin-u.ac.jp
Sponsor or person
Institute
Department of Neuropsychiatry, Kyorin 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
Address
Tel
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
| 2008 | Year | 09 | Month | 10 | 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
Completed
Date of protocol fixation
| 2008 | Year | 06 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
| 2010 | Year | 10 | Month | 01 | Day |
Date trial data considered complete
| 2010 | Year | 10 | Month | 01 | Day |
Date analysis concluded
| 2011 | Year | 03 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2008 | Year | 09 | Month | 10 | Day |
Last modified on
| 2010 | Year | 10 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001652
