UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023447 |
|---|---|
| Receipt number | R000026997 |
| Scientific Title | Psychophysiological study of Gender Identity Disorder |
| Date of disclosure of the study information | 2016/09/01 |
| Last modified on | 2021/02/05 12:07:09 |
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Basic information
Public title
Psychophysiological study of Gender Identity Disorder
Acronym
Psychophysiological study of Gender Identity Disorder
Scientific Title
Psychophysiological study of Gender Identity Disorder
Scientific Title:Acronym
Psychophysiological study of Gender Identity Disorder
Region
| Japan |
Condition
Condition
Gender Identity Disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Through the Prepulse Inhibition test, we aim to reveal the pasthogenesis of Gender Identity Disorder
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The sensitivity and specificity of Prepulse Inhibition test for Gender Identity Disorder
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
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Prepulse Inhibition test, once
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
F64.0 of ICD-10
Key exclusion criteria
F64.1, F64.2, F65.1 of ICD-10 and Disorders of sex development
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Yoneda |
Organization
Osaka Medical College
Division name
Dept. of Neuropsychiatry
Zip code
Address
2-7 Daigakumachi Takatsuki-city Osaka
TEL
072-683-1221
psy002@osaka-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Jun Koh |
Organization
Osaka Medical College
Division name
Dept. of Neuropsychiatry
Zip code
Address
2-7 Daigakumachi Takatsuki-city Osaka
TEL
072-683-1221
Homepage URL
psy012@osaka-med.ac.jp
Sponsor or person
Institute
Dept. of Neuropsychiatry, Osaka Medical College
Institute
Department
Personal name
Funding Source
Organization
Dept. of Neuropsychiatry, Osaka Medical College
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
none
Name of secondary funder(s)
none
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
大阪医科大学（大阪府）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 09 | 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
No longer recruiting
Date of protocol fixation
| 2016 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 05 | Month | 02 | Day |
Anticipated trial start date
| 2016 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 11 | Month | 30 | Day |
Date trial data considered complete
| 2018 | Year | 12 | Month | 30 | Day |
Date analysis concluded
| 2019 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 08 | Month | 02 | Day |
Last modified on
| 2021 | Year | 02 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026997
