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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000018519
Receipt No. R000021424
Scientific Title Clinical investigation for the relation between dose amounts of antipsychotics and skin carbonylstress condition.
Date of disclosure of the study information 2015/08/01
Last modified on 2019/02/03

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Basic information
Public title Clinical investigation for the relation between dose amounts of antipsychotics and skin carbonylstress condition.
Acronym Antipsychotics and skin carbonyl stress.
Scientific Title Clinical investigation for the relation between dose amounts of antipsychotics and skin carbonylstress condition.
Scientific Title:Acronym Antipsychotics and skin carbonyl stress.
Region
Japan

Condition
Condition schizophrenia
Classification by specialty
Dermatology Psychiatry Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the relation among the type and/or dose amounts of antipsychotics, akin carbonylstress and photodermatosis.
Basic objectives2 Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Measurement of skin carbonylstress using TruAge Scanner.
Measurement of minimum response dose using UV-mate.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Device,equipment
Interventions/Control_1 medication with antipsychotics
Interventions/Control_2 Exposure of UV-A using UV-mate.
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
59 years-old >=
Gender Male and Female
Key inclusion criteria Schizophrenia (Clinician-Rated Dimensions of Psychosis Symptom Severity less than 3).
Out-and/or in-patients showing good compliance at least one month with fixed antipsychotics.
Key exclusion criteria (1) severe patinets who can not understand the mean of present study fully.
(2) Patients with porphyria and xeroderma pigmentosum.
(3) Patients with polypharmacy more than three.
(4) Patients with diabetus mellitus.
(5) Patinetns with atopic dermatitis.
(6) Patients with renal failure.
(7) BMI > 30.
Target sample size 48

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tohru Ohnuma
Organization Juntendo University, Faculty of Medicine,
Division name Department of Psychiatry
Zip code
Address 2-1-1 Hongo Bunkyo-ku, Tokyo 113-8421, Japan.
TEL 03-3813-3111
Email otoru@juntendo.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tohru Ohnuma
Organization untendo University, Faculty of Medicine,
Division name Department of Psychiatry
Zip code
Address 2-1-1 Hongo Bunkyo-ku, Tokyo 113-8421, Japan.
TEL 03-3813-3111
Homepage URL
Email otoru@juntendo.ac.jp

Sponsor
Institute Department of Psychiatry,
Juntendo University, Faculty of Medicine,
Institute
Department

Funding Source
Organization The Juntendo Institute of Mental Health (an incorporated foundation)
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
Email

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
Publication of results Published

Result
URL related to results and publications https://onlinelibrary.wiley.com/doi/pdf/10.1002/mpr.1769
Number of participants that the trial has enrolled
Results We investigated the relationship among skin AGE levels, minimal response dose (MRD) with UVA for photosensitivity and the daily dose of antipsychotic agents in patients with schizophrenia and healthy controls.
We enrolled 14 patients with schizophrenia and 14 healthy controls. Measurement of skin AGE levels was conducted with AGE scanner, a fluorometric method for assaying skin AGE levels. Measurement of MRD was conducted with UV irradiation device.
Skin AGE levels and MRD at 24, 48 and 72 h in patients with schizophrenia showed a higher tendency for photosensitivity than in the controls, but the difference was statistically insignificant. Multiple linear regression analysis using skin AGE levels failed to show any influence of independent variables. MRD did not affect skin AGE levels.
Photosensitivity to UVA in patients with schizophrenia recieving treatment with antipsychotic agents might not be affected by skin AGE levels.
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
2015 Year 07 Month 15 Day
Date of IRB
Anticipated trial start date
2015 Year 09 Month 01 Day
Last follow-up date
2019 Year 02 Month 02 Day
Date of closure to data entry
2019 Year 02 Month 02 Day
Date trial data considered complete
2019 Year 02 Month 02 Day
Date analysis concluded
2019 Year 02 Month 02 Day

Other
Other related information

Management information
Registered date
2015 Year 08 Month 01 Day
Last modified on
2019 Year 02 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021424

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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