UMIN-CTR Clinical Trial

Basic information
Public title	Effectiveness of multiple task program with exercise and cognitive tasks for schizophrenia
Acronym	Effectiveness of multiple task program for schizophrenia
Scientific Title	Effectiveness of multiple task program with exercise and cognitive tasks for schizophrenia
Scientific Title:Acronym	Effectiveness of multiple task program for schizophrenia
Region	Japan

Condition
Condition	schizophrenia
Classification by specialty	Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We aim to examine whether multiple task program is more effective than treatment as usual for schizophrenia.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	BACS WCST
Key secondary outcomes	FEIT PANSS LASMI RAS BPNFSF NIRS

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Behavior,custom
Interventions/Control_1	multiple task program
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	50 years-old >
Gender	Male and Female
Key inclusion criteria	Participants are diagnosed with schizophrenia according to ICD-10
Key exclusion criteria	orthopedic disease walking assist instrument
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Yasuhiro Middle name Last name Matsuda
Organization	Nara Medical University School of Medicine
Division name	Department of Psychiatry
Zip code	6348522
Address	840 Shijo-cho, Kashihara, Nara 634-8523, Japan
TEL	0744-22-3051
Email	yasumatsuda319@hotmail.com

Public contact
Name of contact person	1st name Yasuhiro Middle name Last name Matsuda
Organization	Nara Medical University School of Medicine
Division name	Department of Psychiatry
Zip code	6348522
Address	840 Shijo-cho, Kashihara, Nara 634-8523, Japan
TEL	0744-22-3051
Homepage URL
Email	yasumatsuda319@hotmail.com

Sponsor
Institute	Nara Medical University School of Medicine
Institute
Department

Funding Source
Organization	KAKENHI
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Nara Medical University School of Medicine
Address	840 Shijo-cho, Kashihara, Nara 634-8523, Japan
Tel	0744-22-3051
Email	smuraka@naramed-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	2020 Year 03 Month 05 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	2019 Year 03 Month 13 Day
Date of IRB	2019 Year 03 Month 13 Day
Anticipated trial start date	2019 Year 04 Month 01 Day
Last follow-up date	2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 03 Month 05 Day
Last modified on	2020 Year 03 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040614