An observational study in Clinical High Risk for Psychosis, sponsored by Shanghai Mental Health Center. Completed at 1 site in China. Open to participants aged 11 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-01-23.
Sponsored by Shanghai Mental Health Center · Observational
Schizophrenia is one of the most consumptive diseases, which brings great loss to patients and their families, and even to the society. Clinical High Risk for Psychosis (CHR) is a concept put forward on the basis of the prodromal stage of schizophrenia. Over the past 20 years, the identification and intervention of CHR has become the focus of psychiatric research, with the primary goal of early identification of biomarkers of susceptibility to schizophrenia and the development of individualized interventions to prevent or delay progression. Longitudinal studies have shown that CHR converted to schizophrenia mainly within two years, with a risk of about 30 percent. Self-disorder is one of the core characteristics of schizophrenia. The two most basic experiences of self-representation are sense of ownership and sense of agency. Sense of ownership refers to the sense that "I" perceives "my" body, while sense of agency refers to the sense that "I" experiences "my" actions and their consequences are initiated by "me". Some studies have shown that patients with schizophrenia show defects in the sense of ownership and agency. The most commonly used paradigm for observing "sense of ownership" and "sense of agency" is the rubber hand illusion (RHI) or the virtual hand illusion (VHI). In this study, the VHI experimental paradigm will be used to detect the self-representation of the individuals at high risk for psychosis, and the clinical outcome will be observed for one year.The hypothesis is that the subjects who exhibit abnormal illusion experience in VHI experiment are more likely to transition into psychotic disorders.
This study is conducted according to the tenets of the Declaration of Helsinki. All participants are recruited at the Shanghai Mental Health Center (SMHC) or its affiliate, the Shanghai Psychotherapy and Psychological Counseling Center (SPCC) with written informed consent, approved by the Research Ethics Committee of SMHC. For those younger than 18 years, both the adolescents and their next of kin or legal guardians are provided informed consents. The outpatients are recommended by doctors to participate in our CHR screening. After being screened and interviewed, those who meet the inclusion criteria are informed and signed written informed consent. Once the subjects are recruited, clinical evaluation, VHI and MCCB test will be conducted. In addition, CHR individuals will be followed up at one-year node.
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This study's enrollment of 160 is close to the median of 150 across 245 observational studies indexed under Psychotic Disorders.
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This study mainly observe the behavioral representation and its predictive role in transition outcome of CHR individuals, who meeting the criteria of psychosis-risk syndromes (COPS) for the existence of one or more of psychosis high risk syndromes, such as brief intermittent psychotic syndrome (BIPS), attenuated positive symptom syndrome (APSS), and genetic risk and deterioration syndrome (DRDS).
Exclusion Criteria:
No intervention. Just use virtual hand illusion (VHI) paradigm to observe the outcome of individuals with CHR at one-year follow-up node and analyze the predictive role of self-representation in transition into psychosis.
Diagnostic Test: Virtual hand illusion (VHI)
In contrast to FES, it is anticipated to observe CHR individuals with similar behavioral performance to FES may presented higher risk of transition.
Diagnostic Test: Virtual hand illusion (VHI)
In contrast to HC, it is anticipated to observe CHR individuals with similar behavioral performance to HC may presented lower risk of transition.
Diagnostic Test: Virtual hand illusion (VHI)
Using VHI, the two basic self-representation of sense of ownership and sense of agency of the subjects will be observed.
Behavioral indicators
To compare the behavioral performance in VHI experimental paradigm among the three groups of CHR, FES, and HC
Time frame: Baseline
Predictive indicators
To analyze the predictive role of self-representation in transition of CHR into psychosis
Time frame: One-year follow-up node
Resting-state brain functional connectivity (FC)
To observe the relationship of the behavioral performance in VHI experimental paradigm with the Resting-state brain functional connectivity
Time frame: Baseline
Event-related potential technique
To observe the relationship of the behavioral performance in VHI experimental paradigm with the error-related negativity
Time frame: Baseline
Neurocognitive function
To observe the relationship of the behavioral performance in VHI experimental paradigm with the neurocognitive functions
Time frame: Baseline
Other predictive indicators
To analyze the predictive role of FC and neurocognitive functions related to self-representation in transition of CHR into psychosis
Time frame: One-year follow-up node
Plan to share: Undecided
This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
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Shanghai Mental Health Center