Functional and Neurochemical Correlates of Treatment Response in Major Depressive Disorder
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Glutamate level in antidepressant non-responders
研究概览
简要总结
This is an ancillary study to a clinical trial that is being conducted at Massachusetts General Hospital. Investigators at MGH are conducting a clinical trial to test the efficacy of ziprasidone together with escitalopram for treatment-resistant depression (NCT00633399). This observational study will involve magnetic resonance scans to examine brain chemistry (neurotransmitter levels), brain activity, and functional connections between brain regions before and after participating in the trial. The neurotransmitters of interest are glutamate, glutamine, and GABA. Comparisons will be made between individuals who receive ziprasidone and individuals who receive an inactive placebo. Differences between participants who respond to standard antidepressants and those who require additional medication will also be examined. All participants will have a baseline magnetic resonance scan before starting medication. The second scan will be after 8 weeks of escitalopram treatment for those who respond or following 8 weeks of escitalopram plus ziaprasidone or placebo (16 weeks after starting) for those who do not respond to escitalopram alone. Participants will complete standard rating scales for depression at each visit.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Aged 18-65
- •Meets DSM-IV criteria for major depressive disorder
- •Meets eligibility criteria for clinical trial of ziprasidone augmentation of escitalopram
- •Capable of providing informed consent
排除标准
- •Meets exclusion criteria for augmentation clinical trial protocol
- •Pregnancy or unwillingness to avoid pregnancy during trial
- •Current or past psychosis or bipolar disorder
- •Substance abuse or dependence in the past six months
- •Clinically significant suicidality
- •Unstable cardiovascular, hepatic, renal, respiratory, endocrine, neurological, or hematological disease or uncontrolled seizures
- •Use of a concomitant medication that acts on glutamate or GABA neurotransmission
- •Contraindication to magnetic resonance imaging (metal implant or device, occupational metal exposure, significant claustrophobia)
结局指标
主要结局
Glutamate level in antidepressant non-responders
时间窗: 8 weeks after starting combination therapy phase
Glutamate levels are measured by magnetic resonance spectroscopy 8 weeks after starting treatment with ziprasidone or placebo in addition to escitalopram.
次要结局
- Glutamine level in treatment-responders following six weeks of antidepressant and non-responders following six weeks of adjunctive treatment.(8 weeks or 16 weeks)
- Glutamine level in treatment-responders following six weeks of antidepressant and non-responders following six weeks of adjunctive treatment(8 weeks)
- GABA level in treatment-responders following six weeks of antidepressant and non-responders following six weeks of adjunctive treatment(8 weeks)
- Glutamine level in antidepressant non-responders(8 weeks)
- GABA level in antidepressant non-responders(8 weeks)
- Functional connectivity in default mode network measured by functional magnetic resonance imaging (fMRI) in treatment-resistant individuals receiving adjunctive treatment(8 weeks after starting combination therapy phase)
- Functional connectivity in default mode network measured by functional magnetic resonance imaging (fMRI) in treatment-resistant individuals receiving adjunctive treatment and treatment-responders receiving an antidepressant(8 weeks)
研究者
Tara Lauriat
Principal Investigator
Mclean Hospital