Lithium Effects on the Brain's Functional and Structural Connectome in the Treatment of Bipolar Disorder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 81
- 试验地点
- 1
- 主要终点
- Functional Connectivity (Fc) changes
研究概览
简要总结
Lithium is highly effective in the treatment of bipolar disorder. This study aims to investigate, for the first time, the impact of lithium monotherapy on the structural and functional connectivity of the brain using MRI imaging.
详细描述
The premise of this proposal is that the clinical efficacy of lithium in bipolar disorder, and its complex effects on multiple brain physiological functions, may be best deciphered using a network properties-metric approach. This approach is critical because it provides insight into the function of brain networks (e.g., resilience to disruption, central hubs), which is likely to be more closely linked to behavioral outcomes. Furthermore, we will conduct an exploratory investigation of the in vivo molecular effects of lithium by measuring peripheral gene expression. To bring these together, we will also explore whether connectome changes serve as mediator between molecular changes (i.e., gene expression) induced by lithium treatment and behavioral changes (e.g., depression, mood stability, suicidality).
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •for BD subjects:
- •ages 18-60 years (inclusive) and able to give voluntary informed consent;
- •Satisfy criteria for Diagnostic and Statistical Manual 5th edition (DSM-V) for BD I or II, current Depressive Episode;
- •17-item Hamilton Depression Rating Scale (HAM-D) score >15 and <25;
- •Young Mania Rating Scale (YMRS) < 8;
- •no psychotropics in the last 2 weeks (if previously on fluoxetine then medication free for 5 weeks) OR on stable psychotropic medications for 12 weeks
- •no lithium treatment for past 6 months;
- •satisfy criteria to undergo an MRI scan based on MRI screening questionnaire;
- •able to be managed as outpatients during the study as ascertained by Clinical Global Severity Scale < 5 (i.e., moderately ill) and no significant suicidal or homicidal ideation or gross disability.
排除标准
- •for BD subjects are:
- •meeting DSM-IV criteria for schizophrenia, schizoaffective disorder, or an anxiety disorder as
- •a primary diagnosis;
- •requiring inpatient treatment;
- •meeting DSM-V criteria for substance dependence within the past 3 months, except caffeine or nicotine;
- •positive urinary toxicology screening at screening visit;
- •use of alcohol in the past 1 week;
- •serious medical or neurological illness;
- •current pregnancy or breast feeding;
- •metallic implants or other contraindications to MRI.
- •Inclusion criteria for healthy subjects:
- •ages 18-60 years and ability to give voluntary informed consent;
- •no history of psychiatric illness or substance abuse or dependence;
- •no significant family history of psychiatric or neurological illness in first degree relative;
- •not currently taking any prescription or centrally acting medications;
- •no use of alcohol in the past 1 week;
- •and no serious medical or neurological illness.
- •Exclusion criteria for healthy subjects are:
- •under 18 years of age;
- •pregnant or breast-feeding;
- •metallic implants or other contraindication to MRI.
研究组 & 干预措施
Healthy Controls
Healthy Controls with no psychiatric history
Bipolar Disorder I or II Depressed
DSM-V Bipolar I or II Depressed treated with lithium
干预措施: Lithium (Drug)
结局指标
主要结局
Functional Connectivity (Fc) changes
时间窗: 2, 8, 26 weeks
Investigate effects of lithium monotherapy treatment of BD on changes in Fc through fMRI imaging from baseline after 2, 8, and 26 weeks of treatment and test whether these changes correlate with improvement in state-related symptoms and longer term mood stability. Healthy controls will also be scanned at the same time points but not treated.
Structural Connectivity (Sc) changes
时间窗: 2, 8, 26 weeks
Investigate effects of lithium monotherapy treatment of BD depression on changes in the diffusion weighted imaging Sc through fMRI imaging from baseline after 2, 8, and 26 weeks and test whether these changes correlate with depression severity and mood stability. Healthy controls will also be scanned at the same time points but not treated.
次要结局
- Changes in peripheral gene expression(2, 8, 26 weeks)
研究者
Amit Anand
Principal Investigator
Brigham and Women's Hospital