ClinicalTrials.gg
Status unknownNCT03965598Updated May 29, 2019

Study on Predictiors and Mechanism of Conversion to Psychosis in Individuals at Ultra-high Risk Group

An observational study in Schizophrenia, sponsored by Second Xiangya Hospital of Central South University. Status unknown at 1 site in China. Open to participants aged 13 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-05-29.

Sponsored by Second Xiangya Hospital of Central South University · Observational

The sponsor has not verified this record recently (last verified May 2019), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
200
Ages
13 Years to 30 Years
Sex
All
01

Study summary

Considering the complex pathological mechanism and the poor treatment outcomes of schizophrenia, early detection and intervention gradually become the key work for the foundational and clinical research in schizophrenia. Ultra-high risk for psychosis (UHP) is defined as individuals at the prodromal stage of schizophrenia. Early intervention in individual at UHP can effectively delay or even prevent the development of the illness. Long-term longitudinal studies suggested that there are clinical outcomes in people at UHP. Nearly 1/3 of individuals at UHP may be naturally relieved without any intervention, about 1/3 of individuals at UHP will remain at the prodromal stage of schizophrenia, and only 1/3 individuals at UHP will eventually develop schizophrenia. In this regard, it will cause adverse effects on false positive individuals if they accept clinical intervention. Unfortunately, it is difficult to accurately predict which individuals at UHP will make a transition to frank illness. To solve this issue, we explore the association between baseline brain structural and functional networks, methylation modifications, gene expression, neurocognitive function and the clinical outcomes of UHP individuals, and to identify the potential biological and clinical predictors for the long-term outcomes in the individuals at UHP. In addition, we also detect the changes of brain structure and function, methylation status and gene expression in individuals at UHP during follow-up, and further to investigate the etiology and pathogenesis of schizophrenia.

02

Conditions studied

  • Schizophrenia

Browse trials for

Keywords

  • Schizophrenia; Ultra-high risk for psychosis; Predictors; Pathogenesis
03

In context

Schizophrenia

3,539 studies on the registry are indexed under Schizophrenia; 473 are open to participants now.

This study's planned enrollment of 200 is above the median of 178 across 503 observational studies indexed under Schizophrenia.

Browse Schizophrenia studies →

Lead sponsor

Second Xiangya Hospital of Central South University is the lead sponsor of 87 studies on the registry; 50 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
13 Years to 30 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Ultra-high risk for psychosis (UHP) is defined as individuals at the prodromal stage of schizophrenia.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 1. age of 13-30 years;
  • 2. meet the diagnostic criteria of COPS prodromal syndrome by SIPS clinical interviews;
  • 3. have not received any psychiatric medication;
  • 4. be in good health, without major mental illness or physical illness;
  • 5. normal intelligence, can be operated on a clinical scale;
  • 6. volunteer to participate in the study and sign the written consent form.

Exclusion criteria

Exclusion Criteria:

  • 1. exclusion of current or previous psychiatric disorders by SCID interview;
  • 2. meet the diagnostic criteria for substance abuse and substance dependence in DSM-IV;
  • 3. contraindications for MRI;
  • 4. pregnant or lactating women.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
200 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Ultra-high risk for psychosis (UHP)

    Ultra-high risk for psychosis (UHP) is defined as individuals at the prodromal stage of schizophrenia. Inclusion Criteria: age of 13-30 years; meet the diagnostic criteria of COPS prodromal syndrome by SIPS clinical interviews; have not received any psychiatric medication; be in good health, without major mental illness or physical illness; normal intelligence, can be operated on a clinical scale; volunteer to participate in the study and sign the written consent form. Exclusion criteria: exclusion of current or previous psychiatric disorders by SCID interview; meet the diagnostic criteria for substance abuse and substance dependence in DSM-IV; contraindications for MRI; pregnant or lactating women.

  • Healthy controls

    Inclusion Criteria: the gender, age, and education level of the group are matched with the Ultra-high risk group; 13 to 30 years old; right-handed; no history of mental illness; no mental disorder consistent with DSM-IV diagnostic criteria within two or three generations; No contraindications for MRI; volunteer to participate in the study and sign the written consent form. Exclusion criteria: history of disturbance of consciousness over 5 minutes; history of brain organic disease or head injury; history of alcohol and drug dependence; history of coma; history of endocrine disease; abnormity in examination of blood, heart, liver, or renal function; pregnant or lactating women.

06

What researchers measure

Primary outcomes

  1. Conversion to psychosis.

    Conversion is operationalized as the criteria of POPS (Presence of Psychotic Symptoms in SIPS/SOPS). Subjects have to demonstrate at least one psychotic level symptom (rated a '6') on at least one of the five P(Positive) symptoms (P1, unusual thought content; P2, suspiciousness; P3, grandiosity; P4, perceptual abnormalities; and P5, disorganized communication), with either sufficient frequency and duration or at a level that is disorganizing or dangerous.

    Time frame: Two years.

07

Study locations

1 of 1 sites recruiting
  • The 2nd Xiangya Hospital of Central South University
    Changsha, Hunan 410011, China
    Recruiting
08

References and documents

Publications

  • He Y, Kosciolek T, Tang J, Zhou Y, Li Z, Ma X, Zhu Q, Yuan N, Yuan L, Li C, Jin K, Knight R, Tsuang MT, Chen X. Gut microbiome and magnetic resonance spectroscopy study of subjects at ultra-high risk for psychosis may support the membrane hypothesis. Eur Psychiatry. 2018 Sep;53:37-45. doi: 10.1016/j.eurpsy.2018.05.011. Epub 2018 Jun 2. PubMed 29870894 ↗
  • He Y, Li Z, Ma X, Yuan L, Ouyang L, Tang J, Tsuang MT, Chen X. Olfactory and cognitive functions in Chinese individuals at clinical high risk for psychosis. Psychiatry Res. 2019 Feb;272:51-53. doi: 10.1016/j.psychres.2018.12.074. Epub 2018 Dec 14. PubMed 30579181 ↗
  • He Y, Yuan L, Li Z, Zhou Y, Ma X, Ouyang L, Chen X. Plasma protein levels of brain-derived neurotrophic factor pathways and their association with cognitive performance in patients with clinical high risk for psychosis and first episode psychosis. Schizophr Res. 2019 Apr;206:460-461. doi: 10.1016/j.schres.2018.11.016. Epub 2018 Nov 28. No abstract available. PubMed 30503369 ↗
  • Wang Y, Ouyang L, Fan L, Zheng W, Li Z, Tang J, Yuan L, Li C, Jin K, Liu W, Chen X, He Y, Ma X. Functional and structural abnormalities of thalamus in individuals at early stage of schizophrenia. Schizophr Res. 2024 Sep;271:292-299. doi: 10.1016/j.schres.2024.07.045. Epub 2024 Jul 29. PubMed 39079406 ↗
  • Ma X, Yang WFZ, Zheng W, Li Z, Tang J, Yuan L, Ouyang L, Wang Y, Li C, Jin K, Wang L, Bearden CE, He Y, Chen X. Neuronal dysfunction in individuals at early stage of schizophrenia, A resting-state fMRI study. Psychiatry Res. 2023 Apr;322:115123. doi: 10.1016/j.psychres.2023.115123. Epub 2023 Feb 20. PubMed 36827856 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 29, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03965598
Lead sponsor
Second Xiangya Hospital of Central South University
Responsible party
Xiaogang Chen (Professor, Second Xiangya Hospital of Central South University) — Principal investigator
First posted
May 29, 2019
Start date
Nov 1, 2016
Primary completion
Dec 31, 2021 (estimated)
Completion
Dec 31, 2022 (estimated)
Last update
May 29, 2019

Study contacts

Xiaogang Chen, Ph.D
Contact
Chenxiaogang@csu.edu.cn
(+86)0731-85531571
Ying He, Ph.D
Contact
yinghe@csu.edu.cn
(+86)0731-85531571
Xiaogang Chen, Ph.D
principal investigator · Professor

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2019. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion