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 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
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
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
