NCT05186077终止不适用
Brain Circuitry Analysis in Bipolar Disorder
Jennifer Sweet1 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2020年10月15日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Characterize white matter (WM) connectivity with DWT to identify an anatomical substrate for BD that has future potential as a therapeutic target
研究概览
简要总结
The goal of this cross-sectional study is to use diffusion-weighted imaging based tractography (DWT) to assess white matter (WM) pathways in treatment-refractory bipolar disorder (REF-BD) and treatment responsive bipolar disorder (RSP-BD) subjects compared to healthy controls (HCs). This project will include a prospective controlled trial to include 50 subjects with REF-BD, 50 patients RSP-BD and 50 healthy volunteers.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Group 1: Healthy Volunteers
- •Inclusion Criteria for Group 1:
- •Male or female ≥18 years of age
- •Capable of understanding/complying with protocol requirements
- •Has competency to understand and sign informed consent form
- •Physically healthy with no acute medical condition and ≤3 stable, chronic medical conditions
- •Without current and/or lifetime psychiatric disorders as assessed by the Mini International Neuropsychiatric Interview for DSM-5 (MINI)
排除标准
- •for Group 1:
- •Acute medical condition or >3 stable, chronic health conditions
- •Significant structural brain lesion
- •Progressive neurological disease
- •Preexisting implanted electrical device
- •Currently pregnant or planning to become pregnant
- •Contraindications to MR imaging
- •Tests positive for cannabis, illegal substances, or prescription medications without valid prescription
- •Currently taking steroids, opioids, or other agents that might affect brain circuitry per research team discretion
- •Use of cigarettes or other nicotine products within 12 hours of imaging visit
- •Use of stimulants 24 hours prior MRI visit
- •Presents an immediate danger to self or others as judged by research psychiatrist
- •Has psychiatric disorder, including alcohol/drug use disorder or personality disorder
- •Group 2: Treatment-Responsive BDI
- •Inclusion Criteria for Group 2:
- •Male or female ≥18 years of age
- •Capable of understanding/complying with protocol requirements
- •Has competency to understand and sign informed consent form
- •Physically healthy with no acute medical condition and ≤3 stable, chronic medical conditions
- •Meets diagnostic criteria for BDI or BDII according to the DSM-5 criteria
- •Must be stable on current BD medications with no dosing changes in the last 30 days or not currently taking any BD medications.
- •Recent mood episode must currently be in remission for > 8 weeks
- •Montgomery-Asberg Depression Rating Scale (MADRS) ≤10 total score during the psychiatric assessments portion and at the MRI visit (if repeated at MRI visit)
- •Young Mania Rating Scale (YMRS) ≤12 total score during the psychiatric assessments portion and at the MRI visit (if repeated at MRI visit)
- •Clinical Global Impression-Severity for Bipolar Disorder (CGI-S-BD) ≤2 during the psychiatric assessments visit
- •Must be adherent (≥ 80%) with BD medication(s)
- •Exclusion Criteria for Group 2:
- •Acute medical condition or >3 stable, chronic health conditions
- •Significant structural brain lesion
- •Progressive neurological disease
- •Preexisting implanted electrical device
- •Currently pregnant or planning to become pregnant
- •Contraindications to MR imaging
- •Tests positive for cannabis, illegal substances, or prescription medications without valid prescription
- •Currently taking steroids, opioids, or other agents that might affect brain circuitry per research team discretion
- •Use of cigarettes or other nicotine products within 12 hours of imaging visit
- •Use of stimulants within 24 hours of imaging visit
- •Presents an immediate danger to self or others as judged by research psychiatrist
- •Has had changes in medications within 30 days
- •Contribution of any co-occurring psychiatric comorbidity disproportionate to contribution of BDI or BDII
- •Meets DSM-5 criteria for current borderline or antisocial personality disorder
- •Meets DSM-5 criteria for alcohol and/or drug use disorder within 6 months, excluding caffeine and/or nicotine
- •Group 3: Treatment-Refractory BDI
- •Inclusion Criteria for Group 3:
- •Male or female ≥18 years of age
- •Capable of understanding/complying with protocol requirements
- •Has competency to understand and sign informed consent form
- •Physically healthy with no acute medical condition and ≤3 stable, chronic medical conditions
- •Meets diagnostic criteria for BDI or BDII according to the DSM-5 criteria
- •Must be stable on drugs, including at least 1 mood stabilizer, with no dosing changes in the last 30 days
- 另有 21 项未显示
结局指标
主要结局
Characterize white matter (WM) connectivity with DWT to identify an anatomical substrate for BD that has future potential as a therapeutic target
时间窗: Day 1
The imaging visit will consist of an MRI with diffusion-weighted imaging (DWI) sequences
次要结局
未报告次要终点
研究者
Jennifer Sweet
Principal Investigator
Case Western Reserve University
研究点 (1)
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