Schizophrenia
Conditions
Interventions
interventional group:Nasal spray of human dental sac mesenchymal stem cell exosomes
Sponsors
Zigong Psychiatric Research Center
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Conforms to the ICD-10 diagnosis of schizophrenia; 2. Aged between 18 and 60; 3. Long-term inpatients with a disease course of more than 5 years; 4. There has been no acute exacerbation in the last 6 months, and the medication regimen has remained unchanged in the last 2 months; 5. The response to adequate and full-course treatment with two different antipsychotic drugs, including clozapine, was not satisfactory; 6. Positive and Negative Symptom Scale - Negative Symptom Factor Score (PANSS-FSNS) >=24; 7. At least two of the three core negative symptoms (N1, N4, and N6) in PANSS are >=4; 8. The total Clinical Impression Scale - Severity of Illness (CGI-S) score is >=4 points.
Exclusion criteria
Exclusion criteria: 1.Has a history of severe allergies; 2.There is a definite organic lesion in the brain; 3.There are severe physical diseases (such as unstable coronary heart disease, malignant arrhythmia, liver and kidney insufficiency, bronchial asthma, acute exacerbation of chronic obstructive pulmonary disease, autoimmune diseases, etc.); 4.There are severe physical diseases (such as unstable coronary heart disease, malignant arrhythmia, liver and kidney insufficiency, bronchial asthma, acute exacerbation of chronic obstructive pulmonary disease, autoimmune diseases, etc.); 5.Those whose conditions fluctuate and need to adjust their medication regimens; 6.Those who do not cooperate with treatment; 7.Those with severe rhinitis or nasal allergies; 8.Have a history of MECT treatment within the last three months; 9.Those at risk of suicide; 10.Pregnant or lactating women, female or male subjects and their spouses who have pregnancy plans during the trial period or who are unwilling to use effective contraceptive measures within 3 months from the trial period to the end of the trial;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events and severity; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in PANSS score;Volume changes in key brain regions; | — |
Countries
China
Contacts
Public ContactLiu Bo
Zigong Psychiatric Research Center
Outcome results
None listed