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

• Conditions: Schizophrenia

• Registration Number: NCT03965598
• Lead Sponsor: Second Xiangya Hospital of Central South University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-11-01
• Status Verified: 2019-05
• Study First Submitted: 2019-05-26
• Study First Submitted QC: 2019-05-26
• Last Update Submitted: 2019-05-26
• Study First Posted: 2019-05-29
• Last Update Posted: 2019-05-29
• Primary Completion: 2021-12-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Conversion to psychosis.	Two years.	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.

Trial Locations

Locations (1)

The 2nd Xiangya Hospital of Central South University; 🇨🇳 Changsha, Hunan, China