Schizophrenia Clinical Trial
Official title:
A Follow-up Study of Clinical Effects of Repetitive Transcranial Magnetic Stimulation on Schizophrenia
NCT number | NCT03940898 |
Other study ID # | JCai |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | July 1, 2017 |
Est. completion date | September 30, 2018 |
Verified date | April 2019 |
Source | Shanghai Mental Health Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Medications have a poor effect on negative symptoms and cognitive function in schizophrenia. In the past, most of the studies on repetitive transcranial magnetic stimulation intervention in patients with schizophrenia used conventional stimulation sites and patterns, and the intervention effect was still controversial. A few studies have achieved positive results with the new stimulation model (TBS model) and the therapeutic target (cerebellar vermis), but the follow-up period did not exceed 2 weeks, and no similar studies have emerged in China. Therefore, this study hypothesized that the TBS-mode rTMS intervention in the cerebellar vermis can improve the negative symptoms, cognitive function, and depressive symptoms of schizophrenia, and the efficacy can be maintained.
Status | Completed |
Enrollment | 64 |
Est. completion date | September 30, 2018 |
Est. primary completion date | September 30, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 50 Years |
Eligibility |
Inclusion Criteria: - the patient met the diagnostic criteria for schizophrenia in ICD-10; - 18-50 years old; - Right handed; - The current condition is stable, and the types and doses of antipsychotic drugs are unchanged; - In the PANSS scale, the score of Pl, P3, P5, P6, and G9 is not more than 5 points, and the score of P2 is not more than 4 points; Exclusion Criteria: - In addition to schizophrenia, patients with other mental illnesses; - Contraindications to rTMS; - Patients receiving ECT(electro-convulsive therapy) in last month; - Pregnant or lactating woman. |
Country | Name | City | State |
---|---|---|---|
China | Shanghai Mental Health Center | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Shanghai Mental Health Center |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | PANSS-N | The efficacy of negative symptoms was assessed based on the patient's score changes on the PANSS(Positive and Negative Syndrome Scale) negative symptom subscale. PANSS is a relatively mature assessment tool commonly used in clinical research to assess the severity of schizophrenia symptoms. It consists of a positive symptom subscale (7 items), a negative symptom subscale (7 items) and a general psychopathological symptom subscale (16 items), a total of 30 items.Each item has specific definitions and operational grading criteria. It is divided into 7 grades according to the level of psychopathology (1~7 points). The higher the score, the heavier the symptoms. The total score of PANSS is 30- 210 points, the positive symptom subscale and the negative symptom subscale are 7-49 points, and the general psychopathological symptoms subscale is 16 to 112 points. | 24 weeks | |
Secondary | MCCB | The efficacy of cognitive function was assessed based on the patient's score changes on MCCB(MATRICS Consensus Cognitive Battery).MCCB is a set of neuropsychological tests specifically designed to assess cognitive function in schizophrenia. The MCCB Chinese version includes 9 subtests: Train Making Test, Brief Assessment of Cognition in Schizophrenia, Hopkins Verbal Learning Test, Wechsler Working Memory, Neuropsychological Assessment Battery: Mazes, Brief visuospatial Memory Test, Categoary Fluency (Animal Naming), MSCEIT Emotional Intelligence Test, Continuous Performance Test-Identical Pairs. After the test, the MCCB computer scoring program is used to convert the rough points of each subtest into T scores, and the overall comprehensive score is calculated by the software. The range of each test and the overall composite score T is 0-100 points. The lower the score, the worse the cognitive function. | 24 weeks | |
Secondary | HAMD-24 | The efficacy of depressive symptoms was assessed based on the patient's total score changes on HAMD(Hamilton Depression Scale).This study used the 24 version of HAMD. Most of the items in the scale use a five-level scoring standard. The score of each item is between 0 and 4 points, with 0 points representing no; 1 point being mild; 2 points being moderate; 3 points being severe; 4 points being extremely severe. A small number of items use a three-level scoring standard, the score of each item is between 0 and 2 points, with 0 points representing no; 1 point being light-moderate; 2 points being severe. The higher the score, the more severe the symptoms. The total score of the scale ranges from 0 to 76 points. | 24 weeks |
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