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

NCT ID: NCT03965598

Last Updated: 2019-05-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-11-01

Study Completion Date

2022-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Schizophrenia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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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

* 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.
Minimum Eligible Age

13 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sun Yat-sen University

OTHER

Sponsor Role collaborator

Second Xiangya Hospital of Central South University

OTHER

Sponsor Role lead

Responsible Party

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Xiaogang Chen

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Xiaogang Chen, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Professor

Locations

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The 2nd Xiangya Hospital of Central South University

Changsha, Hunan, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xiaogang Chen, Ph.D

Role: CONTACT

(+86)0731-85531571

Ying He, Ph.D

Role: CONTACT

(+86)0731-85531571

Facility Contacts

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Xiaogang Chen, Ph.D

Role: primary

(+86)0731-85531571

Ying He, Ph.D

Role: backup

(+86)0731-85531571

References

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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.

Reference Type BACKGROUND
PMID: 29870894 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30579181 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30503369 (View on PubMed)

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.

Reference Type DERIVED
PMID: 39079406 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36827856 (View on PubMed)

Other Identifiers

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81871056

Identifier Type: -

Identifier Source: org_study_id

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