NCT05262790

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
253

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2013

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 26, 2013

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
5.1 years until next milestone

First Submitted

Initial submission to the registry

February 22, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 2, 2022

Completed
Last Updated

March 2, 2022

Status Verified

December 1, 2021

Enrollment Period

3.4 years

First QC Date

February 22, 2022

Last Update Submit

February 22, 2022

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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

Study Arms (3)

PNS group

The patients with prominently negative symptoms (PNS) had a greater score on the negative than on the positive subscale of the PANSS, a negative symptoms score \> 20, and at least one of items from PANSS negative symptoms scale ≥ 4 points

Other: This is not an intervention study

PPS group

The patients with predominantly positive symptoms (PPS) had a greater score on the positive than on the negative subscale of the PANSS

Other: This is not an intervention study

Control

Healthy control

Other: This is not an intervention study

Interventions

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Age GroupsAdult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • 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
  • 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

You may not qualify if:

  • (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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

SchizophreniaCognitive Dysfunction

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersCognition DisordersNeurocognitive Disorders

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 22, 2022

First Posted

March 2, 2022

Study Start

June 26, 2013

Primary Completion

December 1, 2016

Study Completion

January 1, 2017

Last Updated

March 2, 2022

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share