Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Primary |
Change in MCCB |
The MATRICS Consensus Cognitive Battery,It can be used for cognitive assessment of schizophrenia, bipolar disorder and other neuropsychiatric diseases,The MCCB covers nine cognitive domains including attention, information processing speed, verbal learning and memory, visual learning and memory, spatial working memory, reasoning, problem solving, social cognition, executive function and fine motor. The working memory domain does not include verbal working memory because the Chinese language would not make feasible the inclusion of the LNS test. |
From baseline to 11days and the 30th day after the end of stimulation |
|
| Primary |
Change in Positive and Negative Symptm Scale(PANSS) score |
The scale to assess the severity of symptoms in schizophrenia.It is an evaluation scale of 30 disparate items scored from 1 to 7 for psychopathological symptoms observed in patients presenting psychotic syndromes, especially schizophrenic states.Three scores obtained with this scale are generally calculated for evaluating three dimensions of the syndrome: positive, negative and general psychopathology, as part of a categorial or dimensional perspective.The minimum value is 30 points, and the maximum value is 210 points.The higher the score, the more severe the relevant symptom is. |
From baseline to 11days and the 30th day after the end of stimulation |
|
| Primary |
Change in Scale for Assessment of Positive Symptoms(SAPS) score |
This scale is used to assess the severity of positive symptoms in schizophrenia. Evaluating four dimensions of the positive symptoms including hallucination, delusion, strange behavior and disorders of the positive thinking form.There are 34 items in the scale, which are divided into four subscales and graded on a six-point scale. The total score of the scale is the sum of 34 individual items, reflecting the severity of positive symptoms. The score range is 0-170, the higher the score, the more severe the symptoms are. The total score of the comprehensive evaluation is the sum of the individual score of the overall evaluation item of the four subscales, which also reflects the severity of positive symptoms, the score range is 0-20. The comprehensive evaluation score of the subscale is the single score of the overall evaluation item of the four subscales, specifically reflecting the severity of the four dimensions of the positive symptoms, the score range is 0-5. |
From baseline to 11days and the 30th day after the end of stimulation |
|
| Primary |
Change in Scale for Assessment of Negative Symptoms(SANS) score |
This scale is used to assess the severity of negative symptoms in schizophrenia. Evaluating five dimensions of the negative symptoms including apathy, poverty of thought, abulia, social withdrawal and disorders of attention.There are 24 items in the scale, which are divided into five subscales and graded on a six-point scale. The total score of the scale is the sum of 24 individual items, reflecting the severity of positive symptoms. The score range is 0-120, the higher the score, the more severe the negative symptoms are. The total score of the comprehensive evaluation is the sum of the individual score of the overall evaluation item of the five subscales, which also reflects the severity of negative symptoms, the score range is 0-25. The comprehensive evaluation score of the subscale is the single score of the overall evaluation item of the five subscales, specifically reflecting the severity of the five dimensions of the negative symptoms, the score range is 0-5. |
From baseline to 11days and the 30th day after the end of stimulation |
|
| Primary |
The data of resting-state functional magnetic resonance imaging |
All patients undergo head MRI scans in Philips Achieva 3.0 T scanner and SIEMENS Prisma 3.0 T scanner. |
From baseline to 11days and the 30th day after the end of stimulation |
|
| Secondary |
Change in Treatment Emergent Symptom Scale(TESS) score |
The scale is used to assess the side effects of various psychotropic drugs in adult patients. Evaluation is based on patient statements, physical examination and laboratory results.The 34 symptoms were summarized into 6 groups of symptoms, including behavioral adverse reactions, laboratory tests, nervous system reactions, autonomic nervous system symptoms, cardiovascular system reactions and others.The scale evaluation requires a three-pronged assessment of each symptom: severity, the relationship between the symptom and the medication, and the treatment. |
From baseline to 11days and the 30th day after the end of stimulation |
|
| Secondary |
The blood sample |
About 20ml blood samples were collected intravenously to test blood routine, liver and kidney function, electrolytes and other routine tests. |
From baseline to 11days and the 30th day after the end of stimulation |
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