UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical investigation for the relation between dose amounts of antipsychotics and skin carbonylstress condition.
Title of the study (Brief title)	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	Tohru Ohnuma
Organization	Juntendo University, Faculty of Medicine,
Division name	Department of Psychiatry
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	Tohru Ohnuma
Organization	untendo University, Faculty of Medicine,
Division name	Department of Psychiatry
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 07 Month 15 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	https://onlinelibrary.wiley.com/doi/pdf/10.1002/mpr.1769
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.
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/icdr_e/ctr_view.cgi?recptno=R000021424