Cerebellar-cortical Circuitry and Prediction of Treatment Response in Early Psychosis
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Cerebellar-cortical functional connectivity
研究概览
简要总结
This study plans to collect 120 patients with first-episode psychosis. Participants will receive multimodal MRI scans (naturalistic fMRI, structural, diffusional) and comprehensive clinical assessments at baseline, and subsequently be treated with either risperidone or aripiprazole for 12 weeks. Clinical assessments for psychotic symptoms will be followed multiple times during the treatment until the 12th week. Data analysis will be conducted at the Psychiatric Research Unit of the Zucker Hillside Hospital.
详细描述
This study plans to collect 120 patients with first-episode psychosis. Participants will receive multimodal MRI scans (naturalistic fMRI, structural, diffusional) and comprehensive clinical assessments at baseline, and subsequently be treated with either risperidone or aripiprazole for 12 weeks. Clinical assessments for psychotic symptoms will be followed multiple times during the treatment until the 12th week. Data analysis will be conducted at the Psychiatric Research Unit of the Zucker Hillside Hospital.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of a first-episode psychotic disorder including: schizophrenia, schizophreniform disorder, schizoaffective disorder, brief psychotic disorder, psychotic disorder Not Otherwise Specified (NOS), bipolar disorder with psychosis, and major depressive disorder with psychosis;
- •Current positive symptoms rated > 3 (moderate) on one or more of the Brief Psychiatric Rating Scale (BPRS) psychosis items: conceptual disorganization, grandiosity, hallucinatory behavior, and unusual thought content;
- •At early phase of illness as defined by having taken antipsychotic drugs for a cumulative lifetime period of 8 weeks or less;
- •Age 15 to 40;
- •Competent to sign informed consent.
排除标准
- •Serious neurological or endocrine disorder or brain trauma;
- •Any medical condition which requires treatment with a medication with psychotropic effects;
- •Significant risk of suicidal or homicidal behavior;
- •Cognitive or language limitations, or any other factor that would preclude subjects providing informed consent;
- •Contraindications to antipsychotic monotherapy;
- •Contraindications to MR imaging (e.g. pacemaker);
- •Pregnancy by self report.
结局指标
主要结局
Cerebellar-cortical functional connectivity
时间窗: July 2025 - December 2029
To investigate the performance of cerebellar-cortical functional connectivity in prediction of antipsychotic response
Cerebellar-cortical structural connectivity
时间窗: July 2025 - December 2029
To investigate the performance of cerebellar white matter microstructures in prediction of antipsychotic response
Cerebellar-cortical functional connectivity
时间窗: 2025-2029
To investigate the performance of cerebellar-cortical functional connectivity in prediction of antipsychotic response
Cerebellar-cortical structural connectivity
时间窗: 2025-2029
To investigate the performance of cerebellar white matter microstructures in prediction of antipsychotic response
次要结局
- Cerebellar structural-functional integration(July 2025 - December 2029)
- Cerebellar structural-functional integration(2025-2029)