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.

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. - Predictive factors for transition to psychosis in UHR subjects

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000030693

Enrollment

Registered

2018-01-06

Start date

2018-02-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ultra high risk for psychosis

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
(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.	—

Measure

Time frame

(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.

—

Secondary

Measure	Time frame
(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	—

Countries

Japan

Contacts

Public ContactSaiko Sasaki

National Center of Neurology and Psychiatry Hospital

sasakis@ncnp.go.jp042-341-2711

Outcome results