UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000054003 |
|---|---|
| Receipt number | R000061643 |
| Scientific Title | A Retrospective Chart Review: Current Status of Patients with Borderline Personality Disorder (BPD) and Medical Care in Japan |
| Date of disclosure of the study information | 2024/04/12 |
| Last modified on | 2024/07/11 14:51:12 |
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Basic information
Public title
A Retrospective Chart Review: Current Status of Patients with mood instability and Medical Care in Japan
Acronym
Chart Review of Patients with mood instability in Japan
Scientific Title
A Retrospective Chart Review: Current Status of Patients with Borderline Personality Disorder (BPD) and Medical Care in Japan
Scientific Title:Acronym
Chart Review for BPD in Japan
Region
| Japan |
Condition
Condition
Borderline Personality Disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To describe the current patient profile, diagnosis, progress, and treatment of BPD in Japan.
Basic objectives2
Others
Basic objectives -Others
Further objectives
1)To clarify association between comorbid psychiatric disorders and treatment for patients with BPD in Japan.
2)To clarify the factors associated with treatment continuation in patients with BPD in Japan.
3)To clarify the factors associated with remission in patients with BPD in Japan.
4)To clarify the factors associated with relapse in patients with BPD in Japan.
5)To clarify the factors associated with suicidal attempts in patients with BPD in Japan.
6)To clarify the medical/social resources related to reintegration in patients with BPD in Japan.
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Proportion of treatment by treatment type for patients with BPD
Key secondary outcomes
Proportion of patients with core symptoms of BPD at the first visit at the study sites
Proportion of types of core symptoms in patients with BPD at the time of BPD diagnosis at the study sites
Period from the first visit to BPD diagnosis
Proportion of patients with psychiatric disorders after BPD diagnosis
Proportion of patients using medical resource after BPD diagnosis and types of medical resource
Proportion of patients using social resource after BPD diagnosis and types of social resource
Proportion of family members (genetically related 1st to 4th degree relatives) with psychiatric disorders that became apparent before and after the patient's BPD diagnosis
Proportion of patients showing improvement, exacerbation, and unchanging of symptoms
Proportion of patients with BPD who have gone into remission
Proportion of patients who achieved social reintegration after BPD diagnosis
Proportion of patients with BPD relapse to patients with BPD who have gone into remission
Proportion of patients with BPD who have attempted suicide
Proportion of patients who have discontinued treatment due to patient's circumstances
Patient background
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Patients who have medical records of the first visit at psychiatry department of the study site, on or after January 1st, 2013
2)Patients with records of BPD diagnosed using DSM-5, ICD-10, DSM-IV-TR or clinically evaluated by experienced physicians who are working as psychiatrists in Japan
3)Patients who have provided informed consent of their own free will (by research subjects, etc. [research subjects or their legally acceptable representatives, etc.) in writing or orally after receiving sufficient explanation from the investigator, etc. and understanding the content. (If it is difficult to obtain informed consent from research subjects, etc., appropriate consent must be obtained. If it is difficult to obtain appropriate consent because the valid contact information is not available due to relocation or other reasons, or obtaining informed consent from research subjects, etc. may interfere with the execution of this study considering the time available and cost, etc. to obtain consent, opt-out enrollment will be permitted.)
Key exclusion criteria
1)Patients with BPD who see the physicians planning this study, including Boehringer Ingelheim Co., Ltd. Employees, the members of the steering committee and advisors
2)Patients who had participated in research studies involving interventions during the target period of data collection
3)Patients judged to be inappropriate by the principal investigator or sub-investigator for some reasons
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Akihiro |
| Middle name | |
| Last name | Takano |
Organization
Nippon Boehringer Ingelheim Co., Ltd. (NBI: Sponsor)
Division name
Mental Health Medicine Dept., Clinical Development Medical Affairs Mental and Retinal Health, Medicine Div.
Zip code
141-6017
Address
ThinkPark Tower 2-1-1 Shinagawa-ku, Tokyo
TEL
03-6417-2200
akihiro.takano@boehringer-ingelheim.com
Public contact
Name of contact person
| 1st name | Taketo |
| Middle name | |
| Last name | Kimura |
Organization
Mebix, Inc.
Division name
Clinical Operations
Zip code
105-0001
Address
Akasaka Intercity 1-11-44 Akasaka, Minato-ku, Tokyo
TEL
03-4362-4500
Homepage URL
BPD-Chart-review@mebix.co.jp
Sponsor or person
Institute
Nippon Boehringer Ingelheim Co., Ltd. (NBI: Sponsor)
Institute
Department
Personal name
Funding Source
Organization
Nippon Boehringer Ingelheim Co., Ltd. (NBI: Sponsor)
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nihonbashi sakura clinic Ethics comittee
Address
Inamura Building 5F, 1-9-2, Kayabacho, Nihonbashi, Chuo-ku, Tokyo
Tel
03-6661-9061
yanagimoto.atsuko@neues.co.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
01）医療法人唐虹会 虹と海のホスピタル（佐賀県）
02）医療法人社団五条会 iこころクリニック日本橋（東京都）
03）よつば加納クリニック（宮崎県）
05）地方独立行政法人 長野県立病院機構 長野県立こころの医療センター駒ヶ根（長野県）
06）独立行政法人 国立病院機構 やまと精神医療センター（奈良県）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 04 | Month | 12 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 01 | Month | 26 | Day |
Date of IRB
| 2024 | Year | 03 | Month | 21 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 12 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This chart review study is the latter part of a series of the BPD non-interventional study (NIS) consisting of two parts: the questionnaire survey and this chart review study. The questionnaire survey revealed an overview of diagnosis and treatment of BPD in Japan. However, the survey had the following limitations: it was a cross-sectional survey, thus, the collected answers were mainly based on subjective impressions of participants (physicians/psychologists), and the survey could not collect individual patient data. Further evaluation of individual patient data would be valuable for understanding the clinical situation around BPD in Japan. Therefore, more detailed information about clinical practice of BPD in Japan will be collected based on actual medical records in this study. This study will be undertaken to investigate the longitudinal management flow of patients and clarify the patient characteristics of BPD.
Management information
Registered date
| 2024 | Year | 03 | Month | 29 | Day |
Last modified on
| 2024 | Year | 07 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061643
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