schizophrenia
Conditions
Interventions
Experimental group: transcutaneous auricular vagus nerve stimulation and conventional drug therapy
Control group:sham stimulation and conventional drug therapy
Sponsors
Kunming mental hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Ages 18-65; 2. Diagnosed with schizophrenia according to ICD-10 criteria; 3. Meets the definition of refractory schizophrenia (defined according to the 2016 TRRIP Working Group Consensus recommendation as: Symptom relief is still insufficient after treatment with at least 2 kinds of adequate [daily dose =600mg/ day equivalent of chlorpromazine], full course of treatment [duration =6 weeks per treatment], and full compliance [actual dose =80% of prescribed dose] [definition of adequate remission: symptom improvement < 20% according to standardized scale]]; 4. Received a steady dose of antipsychotic medication for at least two months prior to screening and remained unchanged during the intervention period; 5. No positive symptoms of acute deterioration occurred within 6 months before screening; 6. PANSS-FSNS (N1, N2, N3, N4, N6, G7, G16) =24; 7. Score =4 on at least two of the three core negative symptom items (N1 emotional retardation, N4 passive/indifferent social withdrawal, N6 lack of spontaneity and fluency in conversation).
Exclusion criteria
Exclusion criteria: 1. PANSS-FSPS (P1, P3, P5, P6, G9) > 19; 2. Two or more of the five PANSS-FSPS items scored =4 (P1 delusion, P3 hallucinatory behavior, P5 exaggeration, P6 paranoia/persecution, G9 unusual thought content); 3. CDSS Calgari Schizophrenia Depression Scale total score =14; 4. Lack of education, inability to communicate effectively and complete research evaluation; 5. Active suicidal/violent behavior assessed by a professional psychiatrist; 6. Have epilepsy and other neurological diseases or history; Have serious diseases of liver, kidney, cardiovascular and cerebrovascular system, hematopoietic system, etc. 7. Obvious organic brain lesions, including craniocerebral trauma and known brain structural lesions; 8. Have been diagnosed with depression, anxiety, obsessive-compulsive disorder and other serious mental diseases; 9. History of taVNS treatment within the last 6 months; 10. Patients with auricular malformations and all other auricular disorders; 11. Pregnant and lactating women who have asked to have children in the last six months or who have not been able to obtain adequate contraception.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PANSS negative symptom scale score; | — |
Secondary
| Measure | Time frame |
|---|---|
| PANSS positive symptom scale score;PANSS total score;SANS score;CGI-S scale score; | — |
Countries
China
Contacts
Public ContactGong Yi
Kunming mental hospital
Outcome results
None listed