Negative SymptomEarly Phase 1NCT04533724
Study on the Gut Microbial Mechanism of Negative Symptoms of Schizophrenia
A Early Phase 1 study testing Amisulpride in people with Negative Symptom and Schizophrenia, run by Shanghai Mental Health Center.
Trial summary
Negative symptoms are one of the five-dimensional symptoms of patients with schizophrenia, and medications are not effective in treating negative symptoms. The mechanism of negative symptoms of schizophrenia is unknown, which may be related to insufficient dopamine function of the prefrontal cortex. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Negative Symptom, Schizophrenia, Amisulpride
- What is being tested?
- Amisulpride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2020to 30 Sep 2022
- Phase
- Early Phase 1
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18-45 years old, Han nationality, no gender limit;
- Meet the diagnostic criteria of "Schizophrenia" in the American Diagnostic Standards for Mental Disorders (DSM-V);
- The first attack, no antipsychotic drugs have been used in the past six months;
- The PANSS negative symptom subscale has at least 3 items with 4 points and above or at least two items with 5 points and above, and the positive symptoms score is less than 19 points;
- The negative symptom score is at least 6 points or more higher than the positive symptom score;
- The cultural, social and educational background is sufficient to understand informed consent and research content.
Who cannot join
- 1.Combined with DSM-V diagnosis other than schizophrenia;
- .G6≥4 points in PANSS, or CDSS≥6 points;
- .SAS Side Reaction Scale> 3 points;
- Organic diseases of the central nervous system;
- In the past two months, there were people who were dependent or abused on alcohol or other substances, which caused significant impairment of social and cognitive function;
- In the past year, there have been major life events such as widowhood;
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- Serious suicide attempts;
- .The current patient's severe and unstable physical disease;
- .Pregnant and lactating women;
- Have a history of antibiotic use of more than 3 days within 3 months;
- Use probiotics (lactic acid products, etc.) for more than 3 days within 3 months;
- Type 1 diabetes and severe diabetes complications;
- .Digestive system diseases such as gastrointestinal inflammation, acute or chronic hepatitis;
- .Severe organ diseases, such as cancer, coronary heart disease, myocardial infarction, cerebral hemorrhage;
- .Have infectious diseases, such as tuberculosis, AIDS;
- Drug treatment of cholecystitis, peptic ulcer, urinary tract infection, acute nephritis, cystitis or hyperthyroidism.
Trial locations and contacts
No sites are listed yet.
About this study
Negative symptoms are one of the five-dimensional symptoms of patients with schizophrenia, and medications are not effective in treating negative symptoms. The mechanism of negative symptoms of schizophrenia is unknown, which may be related to insufficient dopamine function of the prefrontal cortex. Amisulpride is a D2/D3 receptor antagonist, which can improve negative symptoms. Intestinal microbes are related to central nervous system mental diseases. Animal studies have found that changes in the intestinal microflora are related to schizophrenia. Clinical studies have found that the gut microbes of patients with schizophrenia are different from those of normal healthy people. Therefore, we are trying to discover the changes of gut microbes in patients with effective amisulpride treatment, and to improve the negative symptoms of schizophrenia patients through the intestinal immune system. The mechanism of brain relationship provides direction, and also provides a new way for the drug treatment of negative symptoms.
Read the detailed description
Negative symptoms are one of the five-dimensional symptoms of patients with schizophrenia. Drug treatment of negative symptoms is not effective. Even if the positive symptoms are relieved, the negative symptoms continue to exist, which seriously affects the personal family social function and is an important risk factor for poor prognosis. The mechanism of negative symptoms of schizophrenia is unknown, which may be related to insufficient dopamine function of the prefrontal cortex, but the pathogenesis is still not fully explained. Amisulpride is a D2/D3 receptor antagonist, which can improve negative symptoms, but the mechanism is not clear. Intestinal microbes are related to central nervous system psychiatric diseases, and intestinal flora imbalance may be an important cause of autism, anxiety, depression, schizophrenia and other mental and psychological diseases. Under pathological conditions, when the intestinal microbiome is disturbed or the intestinal mucosal barrier is destroyed, microbial-related molecules stimulate macrophages and dendritic cells to produce pro-inflammatory cytokines, which in turn activate adaptive immune cells, leading to the destruction of immune homeostasis and enteric nerves The system can also interact with the central nervous system through the brain-gut axis. Intestinal microbes may also influence the occurrence of mental illness through metabolites. Animal studies have found that changes in the intestinal microflora are related to schizophrenia. Clinical studies have found that the gut microbes of patients with schizophrenia are different from those of normal healthy people. Therefore, we are trying to discover the changes of gut microbes in patients with effective amisulpride treatment, and to improve the negative symptoms of schizophrenia patients through the intestinal immune system. The mechanism of brain relationship provides direction, and also provides a new way for the drug treatment of negative symptoms. This study intends to select 30 patients with schizophrenia with dominant negative symptoms (study group) and 15 healthy people with similar living environment (control group), and the study group will be treated with amisulpride (flexible treatment), negative symptom factor The score reduction rate reached 20% for the effective group. Followed up for 8 weeks, fresh stool samples were collected at the baseline, 2, 4, and 8 weekends for 16S rRNA sequencing and short-chain fatty acid detection, and whole blood samples for immune factors (IL-1β, IL-6, IL-10, TNF) -α) Test to assess the negative symptom factor scores of PANSS, CDSS, CGI, TESS, SAS, and Barnes akathisia, and evaluate the patient's negative symptoms, depressive symptoms, efficacy and adverse reactions in turn. Comparing the differences in the intestinal microflora of the two groups at baseline, the correlation between the changes of the intestinal microflora of the effective group of amisulpride and the immune factors and negative symptoms. To understand the pathogenesis of schizophrenia patients with dominant negative symptoms through the gut microbiota-brain axis.
- Conditions
- Negative Symptom, Schizophrenia, Amisulpride, Gut Microbiomes
- Being tested
- Amisulpride
- Keywords
- Gut microbiota-brain axis, Negative symptom, Schizophrenia, Amisulpride
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmisulprideDrug
The amisulpride treatment group was given amisulpride tablets. The dose: the initial dose was 50 mg/d. The doctor titrated the dose to the therapeutic amount within 1 to 2 weeks according to the patient's condition. The maximum dose was 300 mg/d, taken with a single meal. Observe for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | Recruit 30 outpatient/inpatient schizophrenia patients (dominant negative symptoms) in Shanghai Mental Health Center . Receives: Drug: Amisulpride |
| Healthy control group | No intervention | 15 cases of normal healthy people (control group) with similar eating habits and ages in the same region were matched with study group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of intestinal microbial flora
The main evaluation index is the difference between the change of intestinal microbial flora in the study group and the control group before and after treatment.
Measured: 12 weeks
Secondary outcomes (1)
PANSS negative symptom scale score reduction rate
The secondary evaluation index is the PANSS negative symptom scale score reduction rate ≥ 20%
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2020
- Study start1 Oct 2020 (estimated)
- Primary completion1 Sep 2022 (estimated)
- Study completion30 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Negative SymptomStudies 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
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Mental Health Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Qinyu Lv, Principal investigator, Shanghai Mental Health Center, Shanghai Jiao Tong University School of MedicineQi Zhang, Study chair, Shanghai Mental Health Center, Shanghai Jiao Tong University School of MedicineZhenghui Yi, Study chair, Shanghai Mental Health Center, Shanghai Jiao Tong University School of MedicineCongze Wang, Study chair, Shanghai Mental Health Center, Shanghai Jiao Tong University School of MedicineHuanling Zhang, Study chair, Shanghai Mental Health Center, Shanghai Jiao Tong University School of MedicineXinxin Huang, Study chair, Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04533724
- Sponsor's protocol ID
- 2020LQY
- Status last verified
- Aug 2020
- First submitted
- 22 Aug 2020
- Last updated
- 1 Sep 2020
- 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 1 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Gut Microbial Mechanism of Negative Symptoms of Schizophrenia
- ClinicalTrials.gov ID
- NCT04533724
- Acronym / sponsor ID
- 2020LQY
- Conditions
- Negative Symptom, Schizophrenia, Amisulpride, Gut Microbiomes
- Keywords
- Gut microbiota-brain axis, Negative symptom, Schizophrenia, Amisulpride
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- Study start
- 1 Oct 2020 (estimated)
- Primary completion
- 1 Sep 2022 (estimated)
- Study completion
- 30 Sep 2022 (estimated)
- First posted
- 1 Sep 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.
Negative symptoms are one of the five-dimensional symptoms of patients with schizophrenia, and medications are not effective in treating negative symptoms. The mechanism of negative symptoms of schizophrenia is unknown, which may be related to insufficient dopamine function of the prefrontal cortex. Amisulpride is a D2/D3 receptor antagonist, which can improve negative symptoms. Intestinal microbes are related to central nervous system mental diseases. Animal studies have found that changes in the intestinal microflora are related to schizophrenia. Clinical studies have found that the gut microbes of patients with schizophrenia are different from those of normal healthy people. Therefore, we are trying to discover the changes of gut microbes in patients with effective amisulpride treatment, and to improve the negative symptoms of schizophrenia patients through the intestinal immune system. The mechanism of brain relationship provides direction, and also provides a new way for the drug treatment of negative symptoms.
Detailed description
Negative symptoms are one of the five-dimensional symptoms of patients with schizophrenia. Drug treatment of negative symptoms is not effective. Even if the positive symptoms are relieved, the negative symptoms continue to exist, which seriously affects the personal family social function and is an important risk factor for poor prognosis. The mechanism of negative symptoms of schizophrenia is unknown, which may be related to insufficient dopamine function of the prefrontal cortex, but the pathogenesis is still not fully explained. Amisulpride is a D2/D3 receptor antagonist, which can improve negative symptoms, but the mechanism is not clear. Intestinal microbes are related to central nervous system psychiatric diseases, and intestinal flora imbalance may be an important cause of autism, anxiety, depression, schizophrenia and other mental and psychological diseases. Under pathological conditions, when the intestinal microbiome is disturbed or the intestinal mucosal barrier is destroyed, microbial-related molecules stimulate macrophages and dendritic cells to produce pro-inflammatory cytokines, which in turn activate adaptive immune cells, leading to the destruction of immune homeostasis and enteric nerves The system can also interact with the central nervous system through the brain-gut axis. Intestinal microbes may also influence the occurrence of mental illness through metabolites. Animal studies have found that changes in the intestinal microflora are related to schizophrenia. Clinical studies have found that the gut microbes of patients with schizophrenia are different from those of normal healthy people. Therefore, we are trying to discover the changes of gut microbes in patients with effective amisulpride treatment, and to improve the negative symptoms of schizophrenia patients through the intestinal immune system. The mechanism of brain relationship provides direction, and also provides a new way for the drug treatment of negative symptoms. This study intends to select 30 patients with schizophrenia with dominant negative symptoms (study group) and 15 healthy people with similar living environment (control group), and the study group will be treated with amisulpride (flexible treatment), negative symptom factor The score reduction rate reached 20% for the effective group. Followed up for 8 weeks, fresh stool samples were collected at the baseline, 2, 4, and 8 weekends for 16S rRNA sequencing and short-chain fatty acid detection, and whole blood samples for immune factors (IL-1β, IL-6, IL-10, TNF) -α) Test to assess the negative symptom factor scores of PANSS, CDSS, CGI, TESS, SAS, and Barnes akathisia, and evaluate the patient's negative symptoms, depressive symptoms, efficacy and adverse reactions in turn. Comparing the differences in the intestinal microflora of the two groups at baseline, the correlation between the changes of the intestinal microflora of the effective group of amisulpride and the immune factors and negative symptoms. To understand the pathogenesis of schizophrenia patients with dominant negative symptoms through the gut microbiota-brain axis.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Drug: AmisulprideRecruit 30 outpatient/inpatient schizophrenia patients (dominant negative symptoms) in Shanghai Mental Health Center . |
| Healthy control group | No intervention | –15 cases of normal healthy people (control group) with similar eating habits and ages in the same region were matched with study group. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 18-45 years old, Han nationality, no gender limit;
- Meet the diagnostic criteria of "Schizophrenia" in the American Diagnostic Standards for Mental Disorders (DSM-V);
- The first attack, no antipsychotic drugs have been used in the past six months;
- The PANSS negative symptom subscale has at least 3 items with 4 points and above or at least two items with 5 points and above, and the positive symptoms score is less than 19 points;
- The negative symptom score is at least 6 points or more higher than the positive symptom score;
Key exclusion criteria (16 listed)
- 1.Combined with DSM-V diagnosis other than schizophrenia;
- .G6≥4 points in PANSS, or CDSS≥6 points;
- .SAS Side Reaction Scale> 3 points;
- Organic diseases of the central nervous system;
- In the past two months, there were people who were dependent or abused on alcohol or other substances, which caused significant impairment of social and cognitive function;
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 |
|---|---|---|
| AmisulprideThe amisulpride treatment group was given amisulpride tablets. The dose: the initial dose was 50 mg/d. The doctor titrated the dose to the therapeutic amount within 1 to 2 weeks according to the patient's condition. The maximum dose was 300 mg/d, taken with a single meal. Observe for 8 weeks. | Drug | Study group |
Primary outcome
The change of intestinal microbial flora
Time frame: 12 weeks
The main evaluation index is the difference between the change of intestinal microbial flora in the study group and the control group before and after treatment.
1 secondary outcome
PANSS negative symptom scale score reduction rate
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2020.
- 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.
Qinyu Lv principal investigator
Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine
Qi Zhang study chair
Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine
Zhenghui Yi study chair
Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Amisulpride in people with Negative Symptom and Schizophrenia, 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 6 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 1 Sep 2020. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Qinyu Lv (18616550357, lvqinyu_louis@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change of intestinal microbial flora (time frame: 12 weeks). 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 1 Sep 2020.