UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018444 |
|---|---|
| Receipt number | R000021192 |
| Scientific Title | Anxiety and depression in patients with retinitis pigmentosa |
| Date of disclosure of the study information | 2015/08/01 |
| Last modified on | 2020/01/29 14:45:42 |
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Basic information
Public title
Anxiety and depression in patients with retinitis pigmentosa
Acronym
Anxiety and depression in RP patients
Scientific Title
Anxiety and depression in patients with retinitis pigmentosa
Scientific Title:Acronym
Anxiety and depression in RP patients
Region
| Japan |
Condition
Condition
Retinitis pigmentosa
Healthy volunteer
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the anxiety state and the depressive state in patients with retinitis pigmentosa
Basic objectives2
Others
Basic objectives -Others
To investigate the anxiety state and the depressive state between patients with retinitis pigmentosa and healthy volunteers
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
The anxiety and the depression using the Hospital Anxiety and Depression Sale(HADS)
Key secondary outcomes
NEI VFQ-25,visual impairment,severe disease,
marital status,bereavement experience, social support,visual rehabilitation,JRPS,
assessment for visual functions including measurements of visual acuity, vusual field
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
1.outpatients with retinitis pigmentosa
2.patients whose agreement was shown
Healthy volunteers
no ocular diseases
Key exclusion criteria
All participants who had a history of psychiatric treatment and psychotropic drug use were excluded
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Taiji |
| Middle name | |
| Last name | Sakamoto |
Organization
Kagoshima University Hospital
Division name
Department of Ophthalmology
Zip code
8908520
Address
8-35-1, Sakuragaoka,Kagoshima-city,Kagoshima,Japan
TEL
099-275-5402
sai.kagoshima.u@gmail.com
Public contact
Name of contact person
| 1st name | Takehiro |
| Middle name | |
| Last name | Yamashita |
Organization
Kagoshima University
Division name
Department of Ophthalmology
Zip code
8908520
Address
8-35-1, Sakuragaoka,Kagoshima-city,Kagoshima,Japan
TEL
099-275-5402
Homepage URL
sai.kagoshima.u@gmail.com
Sponsor or person
Institute
Kagoshima University
Institute
Department
Personal name
Funding Source
Organization
Kagoshima University
Department of Ophthalmolpgy
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
Kagoshima University Department of Ophthalmolpgy
Address
8-35-1, Sakuragaoka,Kagoshima-city,Kagoshima,Japan
Tel
099-275-5111
isgskkrs@kuas.kagoshima-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
| 2015 | Year | 08 | Month | 01 | Day |
Related information
URL releasing protocol
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5912752/
Publication of results
Published
Result
URL related to results and publications
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5912752/
Number of participants that the trial has enrolled
112
Results
The hads-A score was not significantly correlated with any visual functions but was significantly correlated with the general health condition (r = -0.34, P<0.001) and the role limitation (r = -0.20, P = 0.03) of the nei vfq25subscale
Results date posted
| 2020 | Year | 01 | Month | 29 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
112 rp patients
Participant flow
All of the patients were consecutively asked to participant in this study at Kagoshima University Hospital, Miyata Eye Hospital, Kofu Kyoritsu Hospital, Osaka University Hospital, and Kyushu University Hospital during August 2015 to February 2017.
Adverse events
none
Outcome measures
the hads and the nei-vfq25 questionnaires.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 07 | Month | 24 | Day |
Date of IRB
| 2016 | Year | 06 | Month | 07 | Day |
Anticipated trial start date
| 2016 | Year | 06 | Month | 07 | Day |
Last follow-up date
| 2018 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
prospective, case-control study
Management information
Registered date
| 2015 | Year | 07 | Month | 27 | Day |
Last modified on
| 2020 | Year | 01 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021192
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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