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

NCT03965598 | Unknown

• 1 other identifier: 81871056
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Schizophrenia

Keywords

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

Outcome Measures

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.

  Two years.

Study Arms (2)

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.

Eligibility Criteria

• Age: 13 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• \. 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.

You may not qualify if:

• \. meet the diagnostic criteria for substance abuse and substance dependence in DSM-IV;
• \. contraindications for MRI;
• \. pregnant or lactating women.

Sponsors & Collaborators

• Second Xiangya Hospital of Central South University: lead
• Sun Yat-sen University: collaborator

Study Sites (1)

The 2nd Xiangya Hospital of Central South University

Changsha, Hunan, 410011, China

RECRUITING

Related Publications (5)

• 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.

  PMID: 29870894 BACKGROUND

• 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.

  PMID: 30579181 BACKGROUND

• 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.

  PMID: 30503369 BACKGROUND

• 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.

  PMID: 39079406 DERIVED

• 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.

  PMID: 36827856 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Genomic DNA and RNA will be extracted respectively from white blood cells in peripheral blood.

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Xiaogang Chen, Ph.D

  Professor

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaogang Chen, Ph.D

CONTACT

(+86)0731-85531571; Chenxiaogang@csu.edu.cn

Ying He, Ph.D

CONTACT

(+86)0731-85531571; yinghe@csu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 26, 2019
• First Posted: May 29, 2019
• Study Start: November 1, 2016
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2022
• Last Updated: May 29, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)