UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022071
Receipt number R000025451
Scientific Title The follow-up study of social anxiety symptom in patients with schizophrenia
Date of disclosure of the study information 2016/04/26
Last modified on 2020/12/09 16:53:14

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Basic information

Public title

The follow-up study of social anxiety symptom in patients with schizophrenia

Acronym

The follow-up study of social anxiety symptom in patients with schizophrenia

Scientific Title

The follow-up study of social anxiety symptom in patients with schizophrenia

Scientific Title:Acronym

The follow-up study of social anxiety symptom in patients with schizophrenia

Region

Japan


Condition

Condition

Schizophrenia

Classification by specialty

Psychiatry

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Evaluate on the relation between the severity change of social anxiety symptom and QOL change from the data in the preceding study

Basic objectives2

Others

Basic objectives -Others

Examine those factors which could be associated with severity change of social anxiety symptom and QOL change from the data in the preceding study

Trial characteristics_1

Exploratory

Trial characteristics_2

Others

Developmental phase

Not applicable


Assessment

Primary outcomes

Evaluate on the relation between the severity change of social anxiety symptom and QOL change from the data in the preceding study

Key secondary outcomes

Examine those factors which could be associated with severity change of social anxiety symptom and QOL change from the data in the preceding study


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 became analysis object in the preceding crossing study
2.Patients who has passed more than 12 months after completion of the preceding crossing study
3.Patients by whom the diagnostic isn't changed to a disease of anything but Schizophrenia of DSM - IV - TR (295.30295.10295.20295.90295.60) after the preceding crossing study completion

Key exclusion criteria

None

Target sample size

200


Research contact person

Name of lead principal investigator

1st name Masafumi
Middle name
Last name Mizuno

Organization

Toho University

Division name

Department of Neuropsychiatry

Zip code

143-8541

Address

6-11-1 Omori nishi,Ota-ku,Tokyo,Japan

TEL

+81-3-3762-4151

Email

mizuno@med.toho-u.ac.jp


Public contact

Name of contact person

1st name Takahiro
Middle name
Last name Nemoto

Organization

Toho University

Division name

Department of Neuropsychiatry

Zip code

143-8541

Address

6-11-1 Omori nishi,Ota-ku,Tokyo,Japan

TEL

+81-3-3762-4151

Homepage URL


Email

takahiro.nemoto@med.toho-u.ac.jp


Sponsor or person

Institute

Medical Affairs
Otsuka Pharmaceutical Co., Ltd.

Institute

Department

Personal name



Funding Source

Organization

Medical Affairs
Otsuka Pharmaceutical Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor

None

Name of secondary funder(s)

None


IRB Contact (For public release)

Organization

Toho University Faculty of Medicine Ethics Committee

Address

Omori Nishi 5-21-16 Ota-ku, Tokyo

Tel

03-3762-4151

Email

med.rinri@ext.toho-u.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

2016 Year 04 Month 26 Day


Related information

URL releasing protocol

https://www.sciencedirect.com/science/article/pii/S0022395620309183

Publication of results

Published


Result

URL related to results and publications

https://www.sciencedirect.com/science/article/pii/S0022395620309183

Number of participants that the trial has enrolled

118

Results

Stepwise multiple regressions examining the change in social functioning using demographic data and changes in clinical variables as explanatory variables demonstrated that the changes in social anxiety and general psychopathology contributed to the change in the SFS. Stepwise multiple regressions for the change in QOL demonstrated that the changes in social anxiety and depression contributed to the change in the WHO QOL scale, and the changes in social anxiety and positive symptoms contributed to the SWNS.

Results date posted

2020 Year 12 Month 09 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results

2020 Year 08 Month 15 Day

Baseline Characteristics

Background Factor     Mean     SD
Sex (M/F)      57/61
Age (years)     31.8     7.19
Age at onset (years)     22.1     6.6
Pre-morbid intelligence(JART)     101.6    9.3
Duration of illness (years)     7.3     5.6
Duration of untreated psychosis(months)     8.3     15.1

Participant flow

Of the 207 schizophrenia outpatients who participated in the preceding cross-sectional study, 118 who gave consent to participate in the 2nd follow-up study were included in this study.

Adverse events

None.

Outcome measures

Changes in LSAS, SFS, GAF, WHO-QOL, and SWNS.

Plan to share IPD

None.

IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2015 Year 05 Month 21 Day

Date of IRB

2015 Year 05 Month 21 Day

Anticipated trial start date

2015 Year 10 Month 14 Day

Last follow-up date

2016 Year 09 Month 08 Day

Date of closure to data entry

2016 Year 11 Month 29 Day

Date trial data considered complete

2019 Year 09 Month 26 Day

Date analysis concluded

2019 Year 09 Month 26 Day


Other

Other related information

None


Management information

Registered date

2016 Year 04 Month 26 Day

Last modified on

2020 Year 12 Month 09 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025451


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name