UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030693 |
|---|---|
| Receipt number | 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 | 2023/01/11 08:41:40 |
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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 | Kazuyuki |
| Middle name | |
| Last name | Nakagome |
Organization
National Center of Neurology and Psychiatry
Division name
Hospital
Zip code
187-8551
Address
4-1-1, Ogawa-Higashi, Kodaira, Tokyo
TEL
042-341-2711
nakagome@ncnp.go.jp
Public contact
Name of contact person
| 1st name | Saiko |
| Middle name | |
| Last name | Sasaki |
Organization
National Center of Neurology and Psychiatry
Division name
Hospital
Zip code
187-8551
Address
4-1-1, Ogawa-Higashi, Kodaira, Tokyo
TEL
042-341-2711
Homepage URL
sasakis@ncnp.go.jp
Sponsor or person
Institute
National Center of Neurology and Psychiatry
Institute
Department
Personal name
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
National Center of Neurology and Psychiatry Ethics Committee
Address
4-1-1, Ogawa-Higashi, Kodaira, Tokyo
Tel
042-341-2711
rinri-jimu@ncnp.go.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
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、東北大学大学院医学系研究科精神神経学分野
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
80
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
No longer recruiting
Date of protocol fixation
| 2016 | Year | 10 | Month | 17 | Day |
Date of IRB
| 2016 | Year | 11 | Month | 15 | Day |
Anticipated trial start date
| 2018 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 04 | Month | 13 | Day |
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
| 2023 | Year | 01 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034881
