Using 18F-FPEB PET to Identify mGLUR5 Availability in Affective Disorders
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 59
- 试验地点
- 1
- 主要终点
- Baseline concentration of mGLUR5 availability
研究概览
简要总结
Evidence suggests that mGLUR5 availability may play a key role in the biology of mood disorders. This study aimed to investigate the changes in metabotropic glutamate receptor 5 (mGLUR5) availability and clinical symptoms in patients with MDD and bipolar disorder(BD) after two months of vortioxetine treatment. The investigators hypothesized that patients with MDD and BP have abnormal mGluR5 availability in certain brain regions, and baseline mGLUR5 availability can predict prognosis the prognosis of MDD and BD. fMRI and NODDI are also used to evaluate the function or neurite condition at baseline and 8 week
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Meet DSM-V criteria for a current depressive episode.
- •Being first-episode patients who were medication-naïve;
- •Score >17 on 17-item Hamilton Depression Rating Scale (HDRS), score >22 on Montgomery-Asberg Depression Rating Scale (MADRS), and score <6 on Young Mania Rating Scale (YMRS).
- •Age 18 to
- •Able to give written informed consent.
排除标准
- •Have a current or past significant medical, neurological or metabolic disorder or head injury
- •Have active, significant suicidal ideation or past suicide attempts
- •Have implanted metallic devices or any MR contraindications
- •Are women who are pregnant or breastfeeding
- •Met DSM-5 criteria for substance use disorder
- •Met DSM-5 criteria for any current Axis I diagnosis (except Generalized Anxiety Disorder)
- •Are MDD patients present with delusions and/or hallucinations
研究组 & 干预措施
MDD
Participants with major depressive disorder (MDD), unmedicated and currently depressed to participate in MRI and [18F]FPEB PET scans
干预措施: Vortioxetine (Drug)
Bipolar
Participants with bipolar disorder, unmedicated and currently depressed to participate in MRI and [18F]FPEB PET scans
干预措施: Quetiapine (Drug)
结局指标
主要结局
Baseline concentration of mGLUR5 availability
时间窗: Day 0
BPND at baseline as measured by PET
neurite density
时间窗: baseline and week8
neurite density from Neurite Orientation Dispersion and Density Imaging (NODDI)
Clinical outcome: Number of Participants with remitters and non-remitters
时间窗: Week 8
Remitters: Hamilton Depression Rating Scale (HAMD-17)≤7, non-remitters: Hamilton Depression Rating Scale (HAMD-17)≥8
functional-connectivity
时间窗: baseline and week8
functional-connectivity from functional-MRI
Change of Hamilton Depression Rating Scale-17 (HAMD-17) score from baseline to 8 weeks
时间窗: Week 8
Change of Hamilton Depression Rating Scale-17 (HAMD-17) score from baseline to 8 weeks, range: 0-51, higher score means more severe symptom of depression
Change in concentration of mGLUR5 availability from baseline to 8 weeks
时间窗: Week 8
BPND changes from baseline to 8 weeks
次要结局
未报告次要终点
研究者
Zhang Yan
Professor
Central South University