Study on the Gut Microbial Mechanism of Negative Symptoms of Schizophrenia

NCT04533724 | Unknown Early Phase 1 DMC

• 1 other identifier: 2020LQY
• Study Type: interventional
• Target: 6
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Negative Symptom; Schizophrenia; Amisulpride; Gut Microbiomes

Keywords

Gut microbiota-brain axis; Negative symptom; Schizophrenia; Amisulpride

Outcome Measures

Primary Outcomes (1)

• 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.

  12 weeks

Secondary Outcomes (1)

• PANSS negative symptom scale score reduction rate

  12 weeks

Study Arms (2)

Study group

EXPERIMENTAL

Recruit 30 outpatient/inpatient schizophrenia patients (dominant negative symptoms) in Shanghai Mental Health Center .

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.

Interventions

Amisulpride DRUG

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

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• Shanghai Mental Health Center: lead

MeSH Terms

Conditions

Schizophrenia

Interventions

Amisulpride

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Qinyu Lv

  Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine

  PRINCIPAL INVESTIGATOR

• Qi Zhang

  Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine

  STUDY CHAIR

• Zhenghui Yi

  Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine

  STUDY CHAIR

• Congze Wang

  Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine

  STUDY CHAIR

• Huanling Zhang

  Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine

  STUDY CHAIR

• Xinxin Huang

  Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine

  STUDY CHAIR

Central Study Contacts

Qinyu Lv

CONTACT

18616550357; lvqinyu_louis@163.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2020
• First Posted: September 1, 2020
• Study Start: October 1, 2020
• Primary Completion: September 1, 2022
• Study Completion: September 30, 2022
• Last Updated: September 1, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share