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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05262790
Other study ID # GMV-2013
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 26, 2013
Est. completion date January 1, 2017

Study information

Verified date December 2021
Source Shanghai Mental Health Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 253
Est. completion date January 1, 2017
Est. primary completion date December 1, 2016
Accepts healthy volunteers
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria: - All the patients satisfied the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-?) 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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
This is not an intervention study

This is not an intervention study

This is not an intervention study


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Shanghai Mental Health Center

Outcome

Type Measure Description Time frame Safety issue
Primary GMV difference among PNS, PPS and HC groups. PNS?PPS and HC will undergo Magnetic Resonance Imaging (MRI) at baseline. And the GMV of the three group was collected and analysed.1)The PNS patients showed longer duration, less positive symptoms, more severe PANSS-total symptoms and negative symptoms (all p values = 0.001) than PPS. 2)compared with HC group, PPS group showed reduced GMV in the right orbital gyrus. baseline
Primary Identifying genes associated with GMV alterations in PNS. 1)PLS1 weighted gene expression profile was positively correlated with PNS vs. HC GMV difference.2)The 2 overlapping genes (GRM7, RASSF7) exhibited significant negative correlations with regional GMV alterations in schizophrenia patients with predominantly negative symptoms. baseline
Primary PPI network construction and hub gene identification. 1)PPI analysis of hub genes revealed a network consisting of 10 connected proteins and 33 edges, which is remarkably significantly higher than the expected 2 edges.2)PPI analysis revealed a network consisting of 461 connected proteins and 706 edges, which is remarkably significantly higher than the expected 621 edges baseline
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