UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000018519
Receipt number 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 09:38:41

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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 or person

Institute

Department of Psychiatry,
Juntendo University, Faculty of Medicine,

Institute

Department

Personal name



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

Value
https://center6.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