Clinical trial NCT05262790: The Difference of Grey Matter Volume Among the Patients of Schizophrenia
Official title: The Difference of Grey Matter Volume Among the Patients of Schizophrenia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Schizophrenia
Neuroimaging
Cognitive Dysfunction
Lead sponsor: Shanghai Mental Health Center
Sponsor class: OTHER
First posted: 2022-03-02
Enrollment: 253
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study population will include individuals with psychotic disorders (schizophrenia or schizophreniform disorder) and healthy comparison participants(without personal or family history of psychotic disorders). Participants will be women and men, all races and ethnicities. Participants with schizophrenia/schizophreniform disorder will be aged 18-60 years.

Brief summary: Schizophrenia is a heritable complex phenotype whose symptoms can be clustered into three domains: positive symptoms, negative symptoms and cognitive impairments. Constellations of negative symptoms in SCZ are composed of diminished motivation and pleasure, such as asociality, anhedonia, and avolition, or diminished expressivity such as blunted affect and alogia. Negative symptoms are associated with decreased quality of life and poor functional outcomes. Although antipsychotics are generally effective on positive symptoms, they are poorly effective on negative symptoms Currently, there are no licensed targeted medications for negative symptoms. In view of these problems, considerable interest in identifying new treatment targets for negative symptoms has grown over the past decade. Despite intense efforts in brain imaging that have opened new opportunities for addressing these issues, the neurobiological mechanism of negative symptoms remains unclear.

Structural brain measures from magnetic resonance imaging (MRI) are highly heritable and representatively have high reproducibility and low measurement error. Prior neuroimaging researches have consistently shown neuroanatomical abnormalities in the brains of individuals with SCZ, with the most robust and consistent group-level structural differences in widespread reduced volumes of hippocampal thalamus, amygdala and nucleus accumbens. SCZ have been associated with widespread structural brain abnormalities, but results from neuroimaging studies have been inconsistent.

Detailed description: Schizophrenia (SCZ) is a heritable complex phenotype whose symptoms can be clustered into three domains: positive symptoms, negative symptoms and cognitive impairments. Constellations of negative symptoms in SCZ are composed of diminished motivation and pleasure, such as asociality, anhedonia, and avolition, or diminished expressivity such as blunted affect and alogia. Negative symptoms are associated with decreased quality of life and poor functional outcomes. Although antipsychotics are generally effective on positive symptoms, they are poorly effective on negative symptoms Currently, there are no licensed targeted medications for negative symptoms. In view of these problems, considerable interest in identifying new treatment targets for negative symptoms has grown over the past decade. Despite intense efforts in brain imaging that have opened new opportunities for addressing these issues, the neurobiological mechanism of negative symptoms remains unclear.

Structural brain measures from magnetic resonance imaging (MRI) are highly heritable and representatively have high reproducibility and low measurement error. Prior neuroimaging researches have consistently shown neuroanatomical abnormalities in the brains of individuals with SCZ, with the most robust and consistent group-level structural differences in widespread reduced volumes of hippocampal thalamus, amygdala and nucleus accumbens. SCZ have been associated with widespread structural brain abnormalities, but results from neuroimaging studies have been inconsistent.

Eligibility criteria: Inclusion Criteria:

* All the patients satisfied the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-Ⅳ) diagnostic criteria for schizophrenia or schizophreniform disorder.
* Women and men
* 18 to 60 years of age
* Able and willing to provide written informed consent; and willing to commit to the study protocol
* Able to read, speak, and understand Chinese

Exclusion Criteria:

* (i) were \<18 years or \>60 years
* (ii) psychotic patients in unstable clinical condition (e.g., being aggressive and uncooperative)
* (iii) had major neurological or other psychiatric disorders, or significant medical condition including neurological disease, severe cardiovascular, hepatic, renal diseases
* (iv)had MRI abnormalities, or had MRI contraindications.

Primary outcomes:
measure: GMV difference among PNS, PPS and HC groups.
timeFrame: baseline
measure: Identifying genes associated with GMV alterations in PNS.
timeFrame: baseline
measure: PPI network construction and hub gene identification.
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: