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Name:
UMIN ID:

Recruitment status Suspended
Unique ID issued by UMIN UMIN000028462
Receipt No. R000032572
Scientific Title Efficacy and Safety of NYT in Treatment-Resistant Schizophrenia: Open-Label Study
Date of disclosure of the study information 2017/07/31
Last modified on 2017/07/31

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Basic information
Public title Efficacy and Safety of NYT in Treatment-Resistant Schizophrenia: Open-Label Study
Acronym NYT for Treatment-Resistant Schizophrenia
Scientific Title Efficacy and Safety of NYT in Treatment-Resistant Schizophrenia: Open-Label Study
Scientific Title:Acronym NYT for Treatment-Resistant Schizophrenia
Region
Japan

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

Objectives
Narrative objectives1 Evaluation both the efficacy and Safety of NYT for Schizophrenia
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes During a 12-week follow-up, psychopathology was assessed using the Positive and Negative Syndrome Scale (PANSS)
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
60 years-old >
Gender Male and Female
Key inclusion criteria Schizophrenia patients, 20-59 age.
Key exclusion criteria Exclusion criteria included pregnancy, lactation, other clinical significant or unstable conditions, and history of alcohol or substance abuse in the last 6 months. No patients had been treated by clozapine in this clinical trial.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tsuyoshi Miyaoka
Organization Shimane University
Division name Psychiatry
Zip code
Address Enyacho 89-1, Izumo City
TEL 853-20-2262
Email miyanyan@med.shimane-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tsuyoshi Miyaoka
Organization Shimane University
Division name Psychiatry
Zip code
Address Enyacho 89-1, Izumo City
TEL 853-20-2262
Homepage URL
Email miyanyan@med.shimane-u.ac.jp

Sponsor
Institute Shimane University
Institute
Department

Funding Source
Organization Shimane University
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2017 Year 07 Month 31 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 Suspended
Date of protocol fixation
2015 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 01 Month 05 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information open-labe study

Management information
Registered date
2017 Year 07 Month 31 Day
Last modified on
2017 Year 07 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032572

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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