Common Mental DisorderNCT04218981
Definitive Selection of Neuroimaging Biomarkers for the Diagnosis and Treatment to Common Mental Disorders
A study testing Antipsychotic drugs, Mood stabilizer and Paroxetine in people with Common Mental Disorder, run by Central South University at 1 site in China.
Trial summary
To explore the whole-brain anatomical and functional abnormalities in drug-naive patients with schizophrenia ,drug-naive patients with BD, drug-naive patients with MDD and healthy controls by using a combination of cross-sectional and longitudinal study designs, including a longitudinal study with 8 weeks of drugs… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Common Mental Disorder
- What is being tested?
- Antipsychotic drugs, Mood stabilizer and Paroxetine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 15 Jan 2020to 31 Dec 2023
- Phase
- Interventional
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Diagnostic criteria for schizophrenia,bipolar disorder, major depressive disorder according to the Structural Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV)
- Never received any treatment before.
- For healthy controls: their first-degree relative had no history of psychiatric disorders.
Who cannot join
- The exclusion criteria for all subjects were as follows: any physical illnesses, such as liver, kidney, and cardiovascular diseases; any current or past neuropsychiatric disorders; any traumatic brain injury; seizures; serious impulsive behavior; drug or alcohol addiction; contraindications for MRI; and pregnancy.
Trial locations and contacts
1 site in 1 country.
About this study
To explore the whole-brain anatomical and functional abnormalities in drug-naive patients with schizophrenia ,drug-naive patients with BD, drug-naive patients with MDD and healthy controls by using a combination of cross-sectional and longitudinal study designs, including a longitudinal study with 8 weeks of drugs treatment. And explore whether there are shared imaging biomarkers between these three common mental disorders.
Read the detailed description
Previous studies suggest that there are brain anatomical and functional abnormalities in patients with schizophrenia, bipolar disorder(BD), major depressive disorder(MDD), and the pathogenesis of these three mental disorders may exist overlaps. However, it remains unclear whether these abnormalities can be used for the diagnosis and prediction of treatment effects in mental disorders. It is also unclear whether there are shared imaging biomarkers between these three common mental disorders. In a word, there still lacks reliable neuroimaging biomarkers in mental disorders. Based on the previous studies, this study aims to examine the whole-brain anatomical and functional abnormalities in drug-naive patients with schizophrenia ,drug-naive patients with BD, drug-naive patients with MDD and healthy controls by using a combination of cross-sectional and longitudinal study designs, including a longitudinal study with 8 weeks of drugs treatment( schizophrenia patients are treated with one antipsychotic drug(olanzapine, risperidone; amisulpride); patients with bipolar disorder are treated with one mood stabilizer(lithium;valproate);patients with major depressive disorder are treated with paroxetine). First, neuroimaging biomarkers are definitively selected in patients with different mental disorders for the purpose of diagnosis by using a cross-sectional design. After that, a longitudinal study is conducted in patients after 8 weeks of drugs treatment to validate that the selected neuroimaging biomarkers can be used to predict treatment response of medication. The definitively selected neuroimaging biomarkers are expected to be useful for the diagnosis and prediction of treatment effects in these three mental disorders; and therefore to be helpful for understanding the pathophysiology of mental disorders.
- Conditions
- Common Mental Disorder
- Being tested
- Antipsychotic drugs, Mood stabilizer, Paroxetine
- Keywords
- schizophrenia, bipolar disorder, neuroimaging, major depressive disorder
- Medical subject headings
- Schizophrenia, Bipolar Disorder, Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antipsychotic drugsDrug
Also called MRI scan
Choose one of these antipsychotics (olanzapine, risperidone; amisulpride) for schizophrenia group
Mood stabilizerDrug
Also called MRI scan
Choose lithium or valproate for bipolar disorder group
ParoxetineDrug
Also called MRI scan
Patients with major depressive disorder are treated with paroxetine
| Study group | Role | What they receive |
|---|---|---|
| Schizophrenia group | Experimental | 1. Schizophrenia was diagnosed using the Structural Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V).
2. MRI scan and evaluation of clinical symptoms at baseline and 8 weeks
3. Choose one of the antipsychotics drugs treatment( olanzapine, risperidone, aminosulpiride) according to the patient's condition Receives: Drug: Antipsychotic drugs |
| Bipolar disorder group | Experimental | 1. Bipolar disorder was diagnosed using the Structural Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V).
2. MRI scan and evaluation of clinical symptoms at baseline and 8 weeks
3. Choose one of the mood stabilizer drugs treatment( lithium, valproate) according to the patient's condition Receives: Drug: Mood stabilizer |
| Major depressive disorder group | Experimental | 1. Major depressive disorder was diagnosed using the Structural Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V).
2. MRI scan and evaluation of clinical symptoms at baseline and 8 weeks
3. Choose paroxetine treatment Receives: Drug: Paroxetine |
| Healthy controls | No intervention | MRI scan at baseline and no drugs treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resting-state functional magnetic resonance imaging (fMRI) data acquisition for all participants
A 3.0 T Siemens scanner (Germany) was applied to obtain the MRI images in the Second Xiangya Hospital of Central South University.The MRI data will be obtained before and after treatment at different follow up point.All participants were told to lie on the scanner with their eyes closed. They wore soundproof headphones and asked to remain still. The parameters were as follows: repetition time of 2710 ms, echo time of 3.78 ms, flip angle of 7°, inversion time of 1000 ms, slice thickness of 1 mm, field of view of 256 mm × 256 mm, matrix of 256 × 256, no gap, and 188 slices.
Measured: 8 week
Positive and Negative Syndrome Scale (PANSS)
The PANSS total scores ,subscale scores were used to evaluate the severity of psychotic symptoms at baseline and eight weeks for schizophrenia.The total score of the PANSS was more than 60.The higher scores mean a worse outcome.
Measured: 8 week
Hamilton Depression Scale-17 (HAMD-17)
HAMD-17 total scores were used to evaluate the severity of depressive symptoms at baseline and eight weeks for major depressive disorder. The total score of the HAMD-17 was more than 17.The higher scores mean a worse outcome.
Measured: 8 week
Young Mania Rating Scale (YMRS)
YMRS total scores were used to evaluate the severity of manic symptoms for bipolar disorder before and after treatment at different follow up point.The higher scores mean a worse outcome.
Measured: 8 week
Brief Cognitive Assessment Tool for schizophrenia(B-CATS)
The investigators will use the B-CATS scale to assess cognitive function before and after treatment at different follow up point.The higher scores mean a better outcome.
Measured: 8 week
Secondary outcomes (1)
Social Disability Screening Schedule(SDSS)
The investigators will use the SDSS scale to assess social function before and after treatment at different follow up point.The higher scores mean a worse outcome.
Measured: 8 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2020
- Study start15 Jan 2020
- Primary completion25 Jun 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Common Mental DisorderStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central South University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guo Wenbin, Central South University
- Investigators
- Wenbin Guo, Study director, The Second Xiangya Hospital, Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04218981
- Sponsor's protocol ID
- 81771447
- Status last verified
- Aug 2024
- First submitted
- 27 Dec 2019
- Last updated
- 21 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Definitive Selection of Neuroimaging Biomarkers for the Diagnosis and Treatment to Common Mental Disorders
- ClinicalTrials.gov ID
- NCT04218981
- Acronym / sponsor ID
- 81771447
- Conditions
- Common Mental Disorder
- Keywords
- schizophrenia, bipolar disorder, neuroimaging, major depressive disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Central South UniversityUniversity, hospital or other
- Study start
- 15 Jan 2020 (actual)
- Primary completion
- 25 Jun 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 6 Jan 2020 (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.
To explore the whole-brain anatomical and functional abnormalities in drug-naive patients with schizophrenia ,drug-naive patients with BD, drug-naive patients with MDD and healthy controls by using a combination of cross-sectional and longitudinal study designs, including a longitudinal study with 8 weeks of drugs treatment. And explore whether there are shared imaging biomarkers between these three common mental disorders.
Detailed description
Previous studies suggest that there are brain anatomical and functional abnormalities in patients with schizophrenia, bipolar disorder(BD), major depressive disorder(MDD), and the pathogenesis of these three mental disorders may exist overlaps. However, it remains unclear whether these abnormalities can be used for the diagnosis and prediction of treatment effects in mental disorders. It is also unclear whether there are shared imaging biomarkers between these three common mental disorders. In a word, there still lacks reliable neuroimaging biomarkers in mental disorders. Based on the previous studies, this study aims to examine the whole-brain anatomical and functional abnormalities in drug-naive patients with schizophrenia ,drug-naive patients with BD, drug-naive patients with MDD and healthy controls by using a combination of cross-sectional and longitudinal study designs, including a longitudinal study with 8 weeks of drugs treatment( schizophrenia patients are treated with one antipsychotic drug(olanzapine, risperidone; amisulpride); patients with bipolar disorder are treated with one mood stabilizer(lithium;valproate);patients with major depressive disorder are treated with paroxetine). First, neuroimaging biomarkers are definitively selected in patients with different mental disorders for the purpose of diagnosis by using a cross-sectional design. After that, a longitudinal study is conducted in patients after 8 weeks of drugs treatment to validate that the selected neuroimaging biomarkers can be used to predict treatment response of medication. The definitively selected neuroimaging biomarkers are expected to be useful for the diagnosis and prediction of treatment effects in these three mental disorders; and therefore to be helpful for understanding the pathophysiology of mental disorders.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Schizophrenia group | Experimental | Drug: Antipsychotic drugs1. Schizophrenia was diagnosed using the Structural Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V). 2. MRI scan and evaluation of clinical symptoms at baseline and 8 weeks 3. Choose one of the antipsychotics drugs treatment( olanzapine, risperidone, aminosulpiride) according to the patient's condition |
| Bipolar disorder group | Experimental | Drug: Mood stabilizer1. Bipolar disorder was diagnosed using the Structural Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V). 2. MRI scan and evaluation of clinical symptoms at baseline and 8 weeks 3. Choose one of the mood stabilizer drugs treatment( lithium, valproate) according to the patient's condition |
| Major depressive disorder group | Experimental | Drug: Paroxetine1. Major depressive disorder was diagnosed using the Structural Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V). 2. MRI scan and evaluation of clinical symptoms at baseline and 8 weeks 3. Choose paroxetine treatment |
| Healthy controls | No intervention | –MRI scan at baseline and no drugs treatment |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Diagnostic criteria for schizophrenia,bipolar disorder, major depressive disorder according to the Structural Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV)
- Never received any treatment before.
- For healthy controls: their first-degree relative had no history of psychiatric disorders.
Key exclusion criteria (1 listed)
- The exclusion criteria for all subjects were as follows: any physical illnesses, such as liver, kidney, and cardiovascular diseases; any current or past neuropsychiatric disorders; any traumatic brain injury; seizures; serious impulsive behavior; drug or alcohol addiction; contraindications for MRI; and pregnancy.
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 |
|---|---|---|
| Antipsychotic drugsAlso: MRI scanChoose one of these antipsychotics (olanzapine, risperidone; amisulpride) for schizophrenia group | Drug | Schizophrenia group |
| Mood stabilizerAlso: MRI scanChoose lithium or valproate for bipolar disorder group | Drug | Bipolar disorder group |
| ParoxetineAlso: MRI scanPatients with major depressive disorder are treated with paroxetine | Drug | Major depressive disorder group |
Primary outcome
Resting-state functional magnetic resonance imaging (fMRI) data acquisition for all participants
Time frame: 8 week
A 3.0 T Siemens scanner (Germany) was applied to obtain the MRI images in the Second Xiangya Hospital of Central South University.The MRI data will be obtained before and after treatment at different follow up point.All participants were told to lie on the scanner with their eyes closed. They wore soundproof headphones and asked to remain still. The parameters were as follows: repetition time of 2710 ms, echo time of 3.78 ms, flip angle of 7°, inversion time of 1000 ms, slice thickness of 1 mm, field of view of 256 mm × 256 mm, matrix of 256 × 256, no gap, and 188 slices.
Positive and Negative Syndrome Scale (PANSS)
Time frame: 8 week
The PANSS total scores ,subscale scores were used to evaluate the severity of psychotic symptoms at baseline and eight weeks for schizophrenia.The total score of the PANSS was more than 60.The higher scores mean a worse outcome.
Hamilton Depression Scale-17 (HAMD-17)
Time frame: 8 week
HAMD-17 total scores were used to evaluate the severity of depressive symptoms at baseline and eight weeks for major depressive disorder. The total score of the HAMD-17 was more than 17.The higher scores mean a worse outcome.
Young Mania Rating Scale (YMRS)
Time frame: 8 week
YMRS total scores were used to evaluate the severity of manic symptoms for bipolar disorder before and after treatment at different follow up point.The higher scores mean a worse outcome.
Brief Cognitive Assessment Tool for schizophrenia(B-CATS)
Time frame: 8 week
The investigators will use the B-CATS scale to assess cognitive function before and after treatment at different follow up point.The higher scores mean a better outcome.
1 secondary outcome
Social Disability Screening Schedule(SDSS)
Time frame: 8 week
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 21 Aug 2024.
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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.
Wenbin Guo study director
The Second Xiangya Hospital, Central South University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Antipsychotic drugs, Mood stabilizer and Paroxetine in people with Common Mental Disorder, run by Central South University at 1 site in China.
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 3 inclusion and 1 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 21 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Resting-state functional magnetic resonance imaging (fMRI) data acquisition for all participants (time frame: 8 week). The study lists 5 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 21 Aug 2024.