Clinical trial NCT03965598: Study on Predictiors and Mechanism of Conversion to Psychosis in Individuals at Ultra-high Risk Group
Official title: Study on Predictiors and Mechanism of Conversion to Psychosis in Individuals at Ultra-high Risk Group
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Schizophrenia
Keywords: Schizophrenia; Ultra-high risk for psychosis; Predictors; Pathogenesis
Lead sponsor: Second Xiangya Hospital of Central South University
Sponsor class: OTHER
Collaborators: name: Sun Yat-sen University
First posted: 2019-05-29
Enrollment: 200
Sex: ALL
Minimum age (years): 13
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Ultra-high risk for psychosis (UHP) is defined as individuals at the prodromal stage of schizophrenia.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Conversion to psychosis.
timeFrame: Two years.
Secondary outcomes:
Other outcomes:
Locations:
city: Changsha
country: China
facility: The 2nd Xiangya Hospital of Central South University
state: Hunan
Study officials:
affiliation: Professor
name: Xiaogang Chen, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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. No abstract available.