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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000030693
Receipt No. R000034881
Scientific Title Explorative study for identifying factors to predict transition to schizophrenia in participants at Ultra High Risk for Psychosis by using bioinformation assessment and cytokine measurements.
Date of disclosure of the study information 2018/01/06
Last modified on 2019/01/07

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Basic information
Public title Explorative study for identifying factors to predict transition to schizophrenia in participants at Ultra High Risk for Psychosis by using bioinformation assessment and cytokine measurements.
Acronym Predictive factors for transition to psychosis in UHR subjects
Scientific Title Explorative study for identifying factors to predict transition to schizophrenia in participants at Ultra High Risk for Psychosis by using bioinformation assessment and cytokine measurements.
Scientific Title:Acronym Predictive factors for transition to psychosis in UHR subjects
Region
Japan

Condition
Condition Ultra high risk for psychosis
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The objective is to explore predictive biomarkers in Ultra High Risk subjects for transition to first-episode psychosis
Basic objectives2 Others
Basic objectives -Others Comparison of biomarkers between Ultra High Risk subjects and healthy controls.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes (a) sleep related information collected using actigraph
Total sleep time(TST), sleep efficiency(SE), wake time after sleep onset(WASO), and sleep latency(SL)
(b) positive symptoms SOPS(scale of prodromal symptoms)
(c) Serum cytokine level, number of blood cells including white blood cell percentage, and CRP: IL-1beta, IL-6, TGF-beta, IL-12, IFN-gamma, TNF-alpha, and sIL-2R: serum level of pro-BDNF, mature-BDNF, and oxytocin, measured in the blood sample collected between 9:00am-10:00am.
Key secondary outcomes (a) Pittsburgh Sleep Quality Index(PSQ)
(b) Specific Levels of Functioning Scale(SLOF)
(c) Beck Depression Inventory-2(BDI-2)
(d) Height, weight, smoking status

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
15 years-old <=
Age-upper limit
35 years-old >=
Gender Male and Female
Key inclusion criteria 1) Provide consent to install actigraph, and to sample bioinformation, capable and willing to follow the research process.
2) Age between 15 to 35.
3) Total IQ higher than or equal to 70

Ultra high risk(UHR)group
1) Meet at least one out of the three types of symptomatology as below (You should be aware that the three types of prodromal symptoms are not mutually exclusive. A patient may fulfill more than one type of symptomatology).
the Criteria of Prodromal Syndromes: COPS
A) Brief Intermittent Psychotic Syndromes: BIPS
B) Attenuated Positive Symptom Syndrome: APSS
C) Genetic Risk and Deterioration Syndrome; GRDS

Health Controls
1) Healthy controls, who were age- and sex- matched with UHR group.
Key exclusion criteria 1) Those who have neurological or medical conditions as below: atypical headache, history of head trauma with loss of consciousness, chronic pulmonary disease, kidney disease, chronic liver disease, thyroid disease, active cancer, cerebrovascular disease, epilepsy, neurological disorder, substance related disorder, or mental retardation(IQ<70), obvious history of psychosis.
2) Those who are not seeking for help.
3) Those who suffer from autoimmune disease(SLE, hyperthyroidism: Graves' disease, ulcerative colitis, Crohn's disease).
4) Regular use of steroid or NSAID.
5) The attending physician decided that the patient was inappropriate to participate in the study.
Target sample size 90

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuyuki Nakagome
Organization National Center of Neurology and Psychiatry
Division name Hospital
Zip code
Address 4-1-1, Ogawa-Higashi, Kodaira, Tokyo
TEL 042-341-2711
Email nakagome@ncnp.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Saiko Sasaki
Organization National Center of Neurology and Psychiatry
Division name Hospital
Zip code
Address 4-1-1, Ogawa-Higashi, Kodaira, Tokyo
TEL 042-341-2711
Homepage URL
Email sasakis@ncnp.go.jp

Sponsor
Institute National Center of Neurology and Psychiatry
Institute
Department

Funding Source
Organization Janssen Pharmaceuticals, Inc.
Organization
Division
Category of Funding Organization Profit organization
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 富山大学医学部精神神経医学講座、東邦大学医学部精神神経医学講座、奈良県立医科大学精神医学講座、久留米大学医学部神経精神医学講座、千葉大学精神保健教育研究センター

Other administrative information
Date of disclosure of the study information
2018 Year 01 Month 06 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
2016 Year 10 Month 17 Day
Date of IRB
Anticipated trial start date
2018 Year 02 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 Case-control study and single-arm longitudinal study

Management information
Registered date
2018 Year 01 Month 05 Day
Last modified on
2019 Year 01 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034881

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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