UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000040884
Receipt number R000046688
Scientific Title Study on the relationship between chronic pain and psychiatric symptoms of schizophrenia.
Date of disclosure of the study information 2020/09/01
Last modified on 2023/12/26 12:33:44

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Basic information

Public title

Study on the relationship between chronic pain and psychiatric symptoms of schizophrenia.

Acronym

Study on the relationship between chronic pain and psychiatric symptoms of schizophrenia.

Scientific Title

Study on the relationship between chronic pain and psychiatric symptoms of schizophrenia.

Scientific Title:Acronym

Study on the relationship between chronic pain and psychiatric symptoms of schizophrenia.

Region

Japan


Condition

Condition

Chronic pain, schizophrenia

Classification by specialty

Psychiatry

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Investigate the relationship between the presence or absence of chronic pain and the positive and negative symptoms of schizophrenia.

Basic objectives2

Others

Basic objectives -Others

Investigate the relationship between the presence or absence of chronic pain and the positive and negative symptoms of schizophrenia.

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Positive and negative symptoms of schizophrenia

Key secondary outcomes



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

20 years-old <=

Age-upper limit

75 years-old >=

Gender

Male and Female

Key inclusion criteria

Those who meet the diagnostic criteria for schizophrenia with DSM-5.

Key exclusion criteria

Patients with serious complications

Target sample size

60


Research contact person

Name of lead principal investigator

1st name Hayato
Middle name
Last name Shimazaki

Organization

The Jikei University Daisan Hospital

Division name

Department of psychiatry

Zip code

201-8601

Address

4-11-1, Izumihoncyo, Komae-shi, Tokyo, Japan

TEL

03-3480-1151

Email

hshimazaki@jikei.ac.jp


Public contact

Name of contact person

1st name Hayato
Middle name
Last name Shimazaki

Organization

The Jikei University Daisan Hospital

Division name

Department of psychiatry

Zip code

201-8601

Address

4-11-1, Izumihoncyo, Komae-shi, Tokyo, Japan

TEL

03-3480-1151

Homepage URL


Email

hshimazaki@jikei.ac.jp


Sponsor or person

Institute

The Jikei University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

The Jikei University School of Medicine

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

The Jikei University School of Medicine

Address

3-25-8, Nishi-Shimbashi, Minato-ku, Tokyo

Tel

0334331111

Email

hshimazaki@jikei.ac.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



Other administrative information

Date of disclosure of the study information

2020 Year 09 Month 01 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

59

Results

Of the 59 eligible patients, 27 had chronic pain and 30 had no pain.

Results date posted

2022 Year 01 Month 13 Day

Results Delayed

Delay expected

Results Delay Reason

Results analysis in progress.

Date of the first journal publication of results


Baseline Characteristics

schizophrenia

Participant flow

Of the 68 patients attending the outpatient clinic, 59 met the enrollment criteria.

Adverse events

None

Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Terminated

Date of protocol fixation

2020 Year 05 Month 11 Day

Date of IRB

2020 Year 07 Month 06 Day

Anticipated trial start date

2020 Year 09 Month 01 Day

Last follow-up date

2021 Year 01 Month 12 Day

Date of closure to data entry

2021 Year 01 Month 12 Day

Date trial data considered complete

2021 Year 01 Month 13 Day

Date analysis concluded

2021 Year 01 Month 15 Day


Other

Other related information

observational study


Management information

Registered date

2020 Year 06 Month 24 Day

Last modified on

2023 Year 12 Month 26 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046688


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name