The Efficacy for Execution Function and Genetic Mechanism of Computerized Cognitive Remediation Therapy for Chronic Schizophrenia
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 154
- 试验地点
- 1
- 主要终点
- The concentration of Brain Derived Neurotrophic Factor (BDNF) used to assess the effectiveness of treatment
研究概览
简要总结
The study group received antipsychotic drugs combined with Computerized Cognitive Remediation Therapy (CCRT) for 4 times/week for 45 minutes each time. The control group only received antipsychotic drugs. For a total of 12 weeks. Brain Derived Neurotrophic Factor (BDNF) and Tropomyosin-related kinase B (Trk B) genes in peripheral blood were detected in both groups before and after treatment. Clinical symptoms and executive function assessment were performed in both groups before and after treatment. The relevance of genes and their effects on downstream protein expression levels led to a molecular genetic mechanism for the efficacy of Computerized Cognitive Remediation Therapy (CCRT) .
详细描述
Among the cognitive disorders of chronic schizophrenia, the most reported is the executive dysfunction of the prefrontal lobe. There is increasing evidence that Computerized Cognitive Remediation Therapy (CCRT) has a significant improvement in the implementation of schizophrenia, but the specific mechanism is unknown. Therefore, this study plans to select 154 patients with chronic schizophrenia who were hospitalized for a long time. They were randomly divided into two groups. The study group received antipsychotic drugs combined with Computerized Cognitive Remediation Therapy (CCRT) for 4 times/week for 45 minutes each time. The control group only received antipsychotic drugs. For a total of 12 weeks. brain-derived neurotrophic factor (BDNF) and tyrosine receptor kinase B(TRK-B) genes in peripheral blood were detected in both groups before and after treatment. Clinical symptoms and executive function assessment were performed in both groups before and after treatment. The relevance of genes and their effects on downstream protein expression levels led to a molecular genetic mechanism for the efficacy of Computerized Cognitive Remediation Therapy (CCRT).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-45 years old, Han nationality, male or female;
- •Comply with the American Diagnostic Criteria for Mental Disorder (DSM-V) diagnostic criteria for "schizophrenia";
- •The course of the disease and continued treatment with antipsychotic drugs for > 2 years, stable for at least one month;
- •Positive NegativeSyndrome Scale (PANSS) < 70 points;
- •intelligence quotient (IQ)>80;
- •Cultural, social and educational backgrounds are sufficient to understand informed consent and research content.
排除标准
- •Concomitant diagnosis in addition to Diagnostic and Statistical Manual of Mental Disorders-V other than schizophrenia;
- •Central nervous system organic diseases;
- •There are alcohol or other substances dependent or abused in the past two months, causing significant social and cognitive impairment;
- •In the past year, there have been major life events such as widowhood;
- •Those who have serious suicide attempts (the third item of the (Hamilton Depression Scale-17,HAMD-17) scale "suicide" ≥ 3 points);
- •The current patient's severe unstable physical disease;
- •pregnant women and lactating women;
- •Those who have received modified electroconvulsive therapy (MECT) and repetitive Transcranial Magnetic Stimulation (rTMS) treatment in the past month;
- •Those who have been ineffective for more than 3 months of systemic psychotherapy.
研究组 & 干预措施
Cognitive Remediation Therapy
The study group received antipsychotic drugs Clozapine combined with Computerized Cognitive Remediation Therapy for 4 times/week for 45 minutes each time. For a total of 12 weeks. Clozapine, dosage, dosage form, and frequency :300~600 mg/d; po; duration: 12 week.
干预措施: Cognitive Remediation Therapy (Other)
Cognitive Remediation Therapy
The study group received antipsychotic drugs Clozapine combined with Computerized Cognitive Remediation Therapy for 4 times/week for 45 minutes each time. For a total of 12 weeks. Clozapine, dosage, dosage form, and frequency :300~600 mg/d; po; duration: 12 week.
干预措施: Clozapine (Drug)
Clozapine
Clozapine, dosage, dosage form, and frequency :300~600 mg/d; po; duration: 12 week.
干预措施: Clozapine (Drug)
结局指标
主要结局
The concentration of Brain Derived Neurotrophic Factor (BDNF) used to assess the effectiveness of treatment
时间窗: the end of 12 week
The Concentration of Brain Derived Neurotrophic Factor (BDNF) will be administered to assess the effectiveness of treatment. Do higher values represent a better outcome.
The score of Positive and Negative Syndrome Scale (PANSS)
时间窗: the end of 12 week
The score of Positive and Negative Syndrome Scale (PANSS) ranges from 19-133 and will be administered to assess the effectiveness of treatment. Do higher values represent a worse outcome.The subscales are summed to compute a total score.
次要结局
- The concentration of tyrosine receptor kinase B(TRK-B) used to assess the effectiveness of treatment(the end of 12 week)