Adjunctive Intermittent Theta-Burst Stimulation for First-Episode Schizophrenia: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Total Effective Rate based on PANSS
研究概览
简要总结
This prospective, randomized, assessor-blinded study investigates the efficacy and safety of adding intermittent theta-burst stimulation (iTBS) to a standard treatment of risperidone and cognitive behavioral therapy (CBT) for patients with first-episode schizophrenia. The study aims to compare clinical symptom improvement, cognitive function changes, and levels of serum biomarkers (GDNF, CK-MB, DHEA-S) between a group receiving the combined therapy (iTBS+risperidone+CBT) and a control group receiving standard therapy (risperidone+CBT) over a 3-month period.
详细描述
Schizophrenia is a severe mental disorder often treated with atypical antipsychotics like risperidone. However, pharmacotherapy alone has limited efficacy, especially for negative symptoms and cognitive deficits. Intermittent theta-burst stimulation (iTBS), a form of repetitive transcranial magnetic stimulation (rTMS), and cognitive behavioral therapy (CBT) are promising adjunctive treatments. This study was designed to prospectively evaluate the synergistic effects of a tripartite therapy. One hundred patients with first-episode schizophrenia were randomized to either an experimental group (iTBS + risperidone + CBT) or an active control group (risperidone + CBT). The primary objective was to assess the difference in clinical effective rate at 3 months, measured by the Positive and Negative Syndrome Scale (PANSS). Secondary objectives included evaluating changes in cognitive function (using subtests from the MATRICS Consensus Cognitive Battery), serum levels of potential biomarkers (GDNF, CK-MB, DHEA-S), and safety. The study aims to provide evidence for integrating iTBS into a multimodal treatment strategy for early-stage schizophrenia.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of first-episode schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5).
- •Age between 18 and 45 years.
- •No prior antipsychotic treatment or a washout period of at least 4 weeks for any previous psychotropic medications.
- •No contraindications to risperidone or iTBS.
- •Educational level of junior high school or above, capable of understanding and completing study assessments.
排除标准
- •Comorbid severe psychiatric disorders or significant organic brain disease.
- •Pregnancy or lactation.
- •Severe alcohol or substance dependence.
- •Concurrent use of medications known to interact significantly with risperidone or affect cognitive function.
- •Conditions that could interfere with cognitive assessment.
- •Endocrine disorders, nutritional diseases, or epilepsy.
- •History of cranial surgery or presence of metal implants in the head.
- •Presence of biomedical devices (e.g., cardiac pacemakers).
研究组 & 干预措施
Experimental: Adjunctive iTBS Group
Participants (n=50) received risperidone (initiated at 1 mg/day and flexibly titrated to a maximum of 6 mg/day) and manualized Cognitive Behavioral Therapy (CBT) administered twice weekly for 12 weeks. In addition, they received active intermittent theta-burst stimulation (iTBS) for 20 sessions (5 days/week for 4 weeks) targeting the left dorsolateral prefrontal cortex (DLPFC).
干预措施: Intermittent Theta-Burst Stimulation (iTBS) (Device)
Experimental: Adjunctive iTBS Group
Participants (n=50) received risperidone (initiated at 1 mg/day and flexibly titrated to a maximum of 6 mg/day) and manualized Cognitive Behavioral Therapy (CBT) administered twice weekly for 12 weeks. In addition, they received active intermittent theta-burst stimulation (iTBS) for 20 sessions (5 days/week for 4 weeks) targeting the left dorsolateral prefrontal cortex (DLPFC).
干预措施: Risperidone (Drug)
Experimental: Adjunctive iTBS Group
Participants (n=50) received risperidone (initiated at 1 mg/day and flexibly titrated to a maximum of 6 mg/day) and manualized Cognitive Behavioral Therapy (CBT) administered twice weekly for 12 weeks. In addition, they received active intermittent theta-burst stimulation (iTBS) for 20 sessions (5 days/week for 4 weeks) targeting the left dorsolateral prefrontal cortex (DLPFC).
干预措施: Cognitive Behavioral Therapy (CBT) (Behavioral)
Active Comparator: Control Group
Participants (n=50) received an identical regimen of risperidone (initiated at 1 mg/day and flexibly titrated to a maximum of 6 mg/day) and manualized Cognitive Behavioral Therapy (CBT) administered twice weekly for 12 weeks, without iTBS.
干预措施: Risperidone (Drug)
Active Comparator: Control Group
Participants (n=50) received an identical regimen of risperidone (initiated at 1 mg/day and flexibly titrated to a maximum of 6 mg/day) and manualized Cognitive Behavioral Therapy (CBT) administered twice weekly for 12 weeks, without iTBS.
干预措施: Cognitive Behavioral Therapy (CBT) (Behavioral)
结局指标
主要结局
Total Effective Rate based on PANSS
时间窗: 3 Months
Clinical efficacy defined by the total effective rate based on the Positive and Negative Syndrome Scale (PANSS). The reduction rate is calculated as: (Baseline PANSS - Post-treatment PANSS) / (Baseline PANSS - 30). Total effective rate is the sum of participants achieving Cure (≥75% reduction), Marked Improvement (26%-74% reduction), or Effective (≥25% reduction).
次要结局
- Change in Serum Glial Cell Line-Derived Neurotrophic Factor (GDNF) Level(Baseline, 3 Months)
- Change in Serum Creatine Kinase-MB (CK-MB) Level(Baseline, 3 Months)
- Change in Serum Dehydroepiandrosterone Sulfate (DHEA-S) Level(Baseline, 3 Months)
研究者
Jiali Cui
Principal investigator
The First Hospital of Hebei Medical University