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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000018444
Receipt No. 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

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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
Email 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
Email sai.kagoshima.u@gmail.com

Sponsor
Institute Kagoshima University
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021192

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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