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

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03965598
• Other study ID #: 81871056
• Status: Recruiting
• Start date: November 1, 2016
• Est. completion date: December 31, 2022

Study information

• Verified date: May 2019
• Source: Second Xiangya Hospital of Central South University
• Contact: Xiaogang Chen, Ph.D
• Phone: (+86)0731-85531571
• Email: Chenxiaogang[@]csu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 13 Years to 30 Years

Eligibility

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.

Related Conditions & MeSH terms

• Mental Disorders
• Psychotic Disorders
• Schizophrenia

Locations

Country	Name	City	State
China	The 2nd Xiangya Hospital of Central South University	Changsha	Hunan

Sponsors (2)

Lead Sponsor	Collaborator
Second Xiangya Hospital of Central South University	Sun Yat-sen University

Country where clinical trial is conducted

China, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.