Schizophrenia
Conditions
Interventions
Olanzapine + Kaixinsan Treatment Group:Take Kaixinsan Granules, 1 sachet each time, twice a day. The dosage and administration of Olanzapine Tablets are the same as those in the conventional drug trea
Olanzapine + Placebo Treatment Group:Olanzapine Tablets are administered orally, with an initial dose of 10 mg once daily. Subsequent doses will be adjusted based on the patients condition, and the ma
Sponsors
Shanghai Mental Health Center
Eligibility
Sex/Gender
All
Age
20 Years to 70 Years
Inclusion criteria
Inclusion criteria: (1) 1) Meet the diagnostic criteria for schizophrenia in the 10th Revision of the International Classification of Diseases (ICD-10); 2) No restriction on gender, aged 20-70 years old, and disease duration < 5 years; 3) Currently receiving regular antipsychotic treatment for more than 1 month; 4) Before the start of the study, patients are informed of the method, process and purpose of this study and voluntarily participate. (2) TCM Syndrome Diagnostic Criteria (based on the TCM Symptom Grading and Quantification Criteria for Schizophrenia): Deficiency of Both Heart and Spleen Syndrome. Major symptoms: Hallucinations and delusions, slow response, inability to concentrate, overthinking and suspiciousness, being alone and speaking little, emotional depression. Minor symptoms: Pale complexion, palpitations or severe palpitations, insomnia with many dreams, timidity and fear of trouble, fatigue and weakness, dizziness, amnesia, pale lips. Tongue and Pulse: Swollen tongue body or tooth marks on the tongue, thin and white tongue coating, deep, thready and forceless pulse, or weak pulse. A diagnosis of Deficiency of Both Heart and Spleen Syndrome can be made when 5 major symptoms plus 6 minor symptoms are present, with reference to the tongue and pulse manifestations. The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) is used to evaluate patients' cognitive symptoms, and the Positive and Negative Syndrome Scale (PANSS) is used to assess patients' psychiatric symptoms. Scoring requirements for RBANS: The raw score of each subtest can be converted into 5 factor scores by referring to the standard table: Immediate Memory, Visuospatial Construction, Language, Attention, and Delayed Memory. Each factor score ranges from 40 to 160. After calculating the sum of the 5 factor scores, the total scale score can be obtained by referring to the table again, which also ranges from 40 to 160. In addition, the corresponding percentile of this score in the general population and its confidence interval can be obtained. A higher score indicates better cognitive function of the patient. PANSS: It is mainly used to assess the symptoms and their severity in patients with different types of schizophrenia. The scale consists of positive symptoms, negative symptoms, general psychopathological symptoms and accessory symptoms, including a total of 30 items, using a 7-point rating scale (scored from 1 to 7). The total score ranges from 30 to 210; a higher score indicates more severe illness. (4) No severe heart, liver, or kidney diseases; no organic brain diseases; no history of tumors, hematological diseases, rheumatism, malnutrition, neurodegenerative diseases, etc. (5) No history of tobacco, alcohol, or other psychoactive substance abuse.
Exclusion criteria
Exclusion criteria: (1) Having severe heart, liver, or kidney diseases; having organic brain diseases; having a history of severe cardiovascular diseases, tumors, hematological diseases, rheumatism, malnutrition, neurodegenerative diseases, or other such diseases; having depressive episodes secondary to other mental illnesses or physical diseases; (2) Having a history of tobacco, alcohol, or other psychoactive substance abuse; (3) Pregnant women; (4) Bipolar disorder; (5) Having participated in other drug clinical trials before enrollment; (6) Lack of informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Repeatable Battery for the Assessment of Neuropsychological Status Scale;Positive and Negative Symptom Scale; | — |
Secondary
| Measure | Time frame |
|---|---|
| Activity of Daily Living Scale;Treatment Emergent Symptom Scale; | — |
Countries
China
Contacts
Public ContactJingjing Wu
Shanghai Mental Health Center
Outcome results
None listed