UMIN-CTR Clinical Trial

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
Institute	Medical Affairs Otsuka Pharmaceutical Co., Ltd.
Institute
Department

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025451