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Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000008065
Receipt No. R000009502
Scientific Title Brain morphology in patients with chizophrenia, who have caused serious cases under the condition of insanity
Date of disclosure of the study information 2012/05/31
Last modified on 2015/06/01

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Basic information
Public title Brain morphology in patients with chizophrenia, who have caused serious cases under the condition of insanity
Acronym Brain morphology in patients with chizophrenia, who have caused serious cases under the condition of insanity
Scientific Title Brain morphology in patients with chizophrenia, who have caused serious cases under the condition of insanity
Scientific Title:Acronym Brain morphology in patients with chizophrenia, who have caused serious cases under the condition of insanity
Region
Japan

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

Objectives
Narrative objectives1 to investigate characteristics of patients with schizophrenia, who had serious violent behaviors
Basic objectives2 Others
Basic objectives -Others as mentioned above
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes MRI images
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
65 years-old >=
Gender Male and Female
Key inclusion criteria forensic patients with schizophrenia who have committed homicide or bodily injury, and patients with schizophrenia who do not have a history of violent behaviors
Key exclusion criteria a history of other neurological diseases or severe head injuries
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Satoru Ikezawa
Organization National Center of Neurology and Psychiatry
Division name Department of Psychiatry
Zip code
Address 4-1-1 Ogawahigashi-machi, Kodaira-city, Tokyo
TEL 042-341-2711
Email satoru.ikezawa@ncnp.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Satoru Ikezawa
Organization National Center of Neurology and Psychiatry
Division name Department of Psychiatry
Zip code
Address 4-1-1 Ogawahigashi-machi, Kodaira-city, Tokyo
TEL 042-341-2711
Homepage URL
Email satoru.ikezawa@ncnp.go.jp

Sponsor
Institute National Center of Neurology and Psychiatry
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization Japanese Society of Forensic Mental Health
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization Japan

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 国立精神・神経医療研究センター病院

Other administrative information
Date of disclosure of the study information
2012 Year 05 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 Enrolling by invitation
Date of protocol fixation
2011 Year 11 Month 15 Day
Date of IRB
Anticipated trial start date
2011 Year 12 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Brain morphology will be evaluated using structural MRI and DTI.
Prospective study.
All appropriate forensic patients and age and sex matched patients with schizophrenia will be included.

Management information
Registered date
2012 Year 05 Month 31 Day
Last modified on
2015 Year 06 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009502


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