Effects of Different Doses of Buspirone Combined with Clozapine on Psychiatric Symptoms and Cognitive Function in Patients with Schizophrenia: a Randomised, Double-blind, Placebo-controlled Trial
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Assessment of psychiatric symptoms
研究概览
简要总结
This study aimed to evaluate the enhancing effects of different doses of buspirone on psychiatric symptoms and cognitive function in patients with schizophrenia. The investigators adopted a prospective, randomised, double-blind, placebo-controlled study design and included 46 patients with schizophrenia being treated at the Fourth People's Hospital of Wuhu. The patients were randomly divided into three groups: the control group, the low-dose group and the high-dose group. The control group received clozapine monotherapy, while the experimental groups received additional buspirone at different doses in addition to clozapine. The Positive and Negative Syndrome Scale (PANSS) and the Chinese version of the Repeatable Battery for the Assessment of Neuropsychological Status were used to evaluate psychiatric symptoms and cognitive function.
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 (Participant, Care Provider)
入排标准
- 年龄范围
- 1 Year 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18-65 years;
- •Meeting the diagnostic criteria for chronic schizophrenia in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV)
- •Current remission of psychotic symptoms. The patients had a relatively stable mental state in the past 4 weeks, with a total score of ≤60 points and a score of ≤4 points on the Positive and Negative Syndrome Scale (PANSS)[15], and there were no signs of acute psychotic symptoms. To ensure that patients were included in the chronic phase, only patients who had been diagnosed with schizophrenia for ≥1 year were recruited, thus avoiding confusion with acute phase cases;
- •Receiving monotherapy with antipsychotic drugs, such as clozapine.
排除标准
- •Pregnant or lactating women;
- •Patients allergic to buspirone;
- •Patients previously diagnosed with cognitive impairment, such as dementia or intellectual disability;
- •Patients with a history of other brain injuries or diseases, such as stroke, traumatic brain injury, epilepsy or intracranial infection;
- •Patients with severe liver or kidney insufficiency;
- •Patients with severe physical diseases or other mental illnesses, such as bipolar disorder, major depressive disorder, alcohol or substance dependence;
- •Patients with a history of using drugs that affect cognitive function during the study period or those who need to adjust the existing treatment regimen;
- •Patients who are unable to cooperate with cognitive function tests or have poor treatment compliance.
研究组 & 干预措施
Control group
Patients received oral clozapine (Jiangsu Pharmaceutical Co., Ltd., Approval No. H32022963) in combination with a placebo. Each dose of the placebo was 1 mg, taken three times a day. Use of placebo: This study employed a double-blind design. Patients in the control group received clozapine monotherapy and took a placebo concurrently. The placebo was identical to buspirone tablets in terms of appearance, shape, colour and packaging to guarantee the double-blind nature of the study. The placebo was custom-made by a third-party pharmaceutical company. Its label only stated 'placebo' and was exactly the same as that of buspirone tablets. This design was intended to eliminate the potential impact of the placebo effect on the study results.
干预措施: Control group (clozapine, placebo) (Drug)
Low-dose group
Patients received oral buspirone tablets (Jiangsu Enhua Pharmaceutical Co., Ltd., Approval No. H19991024) in combination with clozapine. The total daily dose of buspirone was 15 mg, divided into three administrations. The dose remained unchanged throughout the entire study period.
干预措施: Low-dose group (buspirone tablets, clozapine) (Drug)
High-dose group
Patients received oral buspirone tablets in combination with clozapine. The initial total daily dose of buspirone was 15 mg, divided into three administrations. One week later, the dose was increased to a total daily dose of 30 mg, also divided into three administrations.
干预措施: High-dose group (buspirone tablets, clozapine) (Drug)
结局指标
主要结局
Assessment of psychiatric symptoms
时间窗: 4 weeks, 8 weeks and 12 weeks
The PANSS was used to evaluate the severity of psychiatric symptoms in schizophrenia. The PANSS is composed of three subscales: Positive Scale, Negative Scale and General Psychopathology Scale. Each item is rated on a scale from 1 to 7, with a total score ranging from 0 to 125; lower scores indicate milder symptoms.
Assessment of cognitive function
时间窗: 4 weeks, 8 weeks and 12 weeks
Cognitive function was assessed using the Chinese version of the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)\[17\]. The RBANS assesses five cognitive domains: immediate memory, visuospatial/constructional abilities, language, attention and delayed memory. Each domain contains specific tasks and scoring criteria.
Adverse event records
时间窗: 4 weeks, 8 weeks and 12 weeks
Throughout the entire study period, detailed records were made of all adverse events reported by patients, including the type of the event, the occurrence time, the duration and the severity level. Particular attention was paid to the potential adverse reactions associated with the combined use of medications, such as drowsiness and dizziness
次要结局
未报告次要终点
研究者
Chuanfu Song
Director
Wuhu Fourth People's Hospital affiliated with Bengbu Medical University