Accelerated Neuromodulation of Prefrontal Circuitry During Clozapine Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- change in activation of the working memory network
研究概览
简要总结
In this study, the investigators will examine whether a type of repetitive transcranial magnetic stimulation called accelerated intermittent theta burst stimulation (iTBS) can augment neurocognition in individuals who receive treatment with clozapine. Following a baseline evaluation and magnetic resonance imaging (MRI), participants will undergo a session of iTBS +MRI and session of sham delivery + MRI. The order for these sessions will be blinded and randomized. The investigators predict that accelerated iTBS will enhance neurocognition relative to sham delivery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A current Diagnostic and Statistical Manual of Mental Disorders 5 (DSM 5)-defined diagnosis of schizophrenia or schizoaffective disorder
- •age 18-65 years
- •at least 4 months of clozapine treatment
- •history of at least 2 failed antipsychotic trials
- •competency and willingness to sign informed consent
- •A clinically optimized dosage of clozapine, unchanged for at least 1 month, with a minimum of 150 mg/day
排除标准
- •Serious neurologic or medical condition/treatment that impacts the brain
- •a significant risk of suicidal or homicidal behavior
- •cognitive or language limitations, or any other factor that would preclude subjects providing informed consent
- •pregnancy or postpartum (<6 weeks after delivery or miscarriage)
- •history of treatment with electroconvulsive therapy
- •contraindications for magnetic resonance imaging (e.g., a pacemaker)
- •Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders 5 (DSM 5)-verified moderate or severe substance use disorder, including alcohol use disorder
- •seizure disorder or prior history of seizures on clozapine
- •patients taking both bupropion and clozapine
- •prior issues with intermittent theta burst stimulation/transcranial magnetic stimulation administration
- •Concomitant treatment with serotonin and norepinephrine reuptake inhibitors will be examined on a case-by-case basis.
研究组 & 干预措施
iTBS, then Sham
干预措施: sham stimulation (Device)
iTBS, then Sham
干预措施: transcranial magnetic stimulation (Device)
Sham, then iTBS
干预措施: sham stimulation (Device)
Sham, then iTBS
干预措施: transcranial magnetic stimulation (Device)
结局指标
主要结局
change in activation of the working memory network
时间窗: 1 hour
Examine whether accelerated intermittent theta burst stimulation (iTBS) is associated with functional magnetic resonance imaging (fMRI)-based changes in activation of the working memory network during AX-continuous performance task engagement
change in brain functional connectivity within the prefrontal cortex
时间窗: 1 hour
Examine changes in left dorsolateral prefrontal cortex-basal forebrain functional connectivity following adjunctive accelerated intermittent theta burst stimulation (iTBS)
次要结局
- explore change in functional magnetic resonance imaging (fMRI) measures versus plasma n-desmethylclozapine/clozapine ratios(1 month)
研究者
Deepak K. Sarpal, M.D.
Assistant Professor
University of Pittsburgh