SchizophreniaNCT05262790
The Difference of Grey Matter Volume Among the Patients of Schizophrenia
An observational study of Schizophrenia and Neuroimaging, run by Shanghai Mental Health Center.
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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Schizophrenia, Neuroimaging, Cognitive Dysfunction
- What is being tested?
- This is not an intervention study
- How many people
- 253 participants
- Where
- No sites listed yet
- Study dates
- 26 Jun 2013to 1 Jan 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Adult
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.
Who may be able to join
- 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
Who cannot join
- (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.
About this study
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.
Read the 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.
- Conditions
- Schizophrenia, Neuroimaging, Cognitive Dysfunction
- Being tested
- This is not an intervention study
- Medical subject headings
- Schizophrenia, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
This is not an intervention studyOther
This is not an intervention studyOther
This is not an intervention studyOther
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: This is not an intervention study | |
| Control | Healthy control Receives: Other: This is not an intervention study |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2022
- Study start26 Jun 2013
- Primary completion1 Dec 2016
- Study completion1 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Shanghai Mental Health CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 253 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Mental Health Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05262790
- Sponsor's protocol ID
- GMV-2013
- Status last verified
- Dec 2021
- First submitted
- 22 Feb 2022
- Last updated
- 2 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Difference of Grey Matter Volume Among the Patients of Schizophrenia
- ClinicalTrials.gov ID
- NCT05262790
- Acronym / sponsor ID
- GMV-2013
- Conditions
- Schizophrenia, Neuroimaging, Cognitive Dysfunction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 253 participants (actual)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- Study start
- 26 Jun 2013 (actual)
- Primary completion
- 1 Dec 2016 (actual)
- Study completion
- 1 Jan 2017 (actual)
- First posted
- 2 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PNS group | – | Other: This is not an intervention studyThe 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 |
| PPS group | – | Other: This is not an intervention studyThe patients with predominantly positive symptoms (PPS) had a greater score on the positive than on the negative subscale of the PANSS |
| Control | – | Other: This is not an intervention studyHealthy control |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Age groups
- Adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- (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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| This is not an intervention study | Other | PNS group |
| This is not an intervention study | Other | PPS group |
| This is not an intervention study | Other | Control |
Primary outcome
GMV difference among PNS, PPS and HC groups.
Time frame: baseline
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.
Identifying genes associated with GMV alterations in PNS.
Time frame: baseline
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.
PPI network construction and hub gene identification.
Time frame: baseline
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Schizophrenia and Neuroimaging, run by Shanghai Mental Health Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
GMV difference among PNS, PPS and HC groups. (time frame: baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2022.