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 2024/05/25 18:32:29

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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

Email

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


Email

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

Email

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)


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 05 Month 25 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061643


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name