Biological Predictors of Response to Antidepressants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Remission of Depressive Symptoms
研究概览
简要总结
This study will use pre-treatment positron emission topography and functional magnetic resonance imaging scans of the brain to predict the most effective antidepressant treatment for people with major depressive disorder.
详细描述
Major depressive disorder (MDD) is characterized by a combination of symptoms that can interfere with a person's ability to work, study, sleep, eat, and enjoy activities that were once pleasurable. Studies have shown that as little as 50% to 60% of individuals with MDD may respond to the first antidepressant medication prescribed. Currently psychiatrists lack tools that allow them to select the treatment plan that is most likely to benefit a particular individual. Some of the chemical abnormalities in the brains of people with MDD are detectable on positron emission topography (PET) scans. There are distinct differences in the PET scans of people with MDD who respond to treatment with a selective serotonin reuptake inhibitor (SSRI), people with MDD who do not respond to SSRI treatment, and people who do not have MDD. This study will use pretreatment PET and functional magnetic resonance imaging (fMRI) scans of the brain to predict which antidepressants will be most effective in people with MDD. This may help to reduce the trial and error currently associated with antidepressant treatment.
We will perform pretreatment PET scans to quantify serotonin transporter (5-HTT) and serotonin 1A (5-HT1A) receptor in patients with major depressive disorder (MDD). All patients will then receive a standardized treatment protocol with a selective serotonin reuptake inhibitor (SSRI), escitalopram. If the patient does not remit, he or she will receive a selective norepinephrine reuptake inhibitor (NRI), desipramine. We hypothesize those patients with high pre and postsynaptic 5-HT1A BP and low 5-HTT BP in specific brain regions will not remit to a SSRI and will remit to a selective NRI. Finally, we will generate a predictive model of remission based on brain imaging outcome measures. Our overall goal is to reduce the trial and error associated with antidepressant treatment by using data from pre-treatment quantification of 5-HT1A receptors and 5-HTT to guide antidepressant treatment selection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Diagnosis of current major depressive disorder
- •Currently depressed
- •Subjects must be generally healthy with no significant medical problems, anemia/blood loss, or cardiac abnormalities
- •Likely to tolerate medication washout
- •Capacity to provide informed consent
- •Off of anti-coagulant/anti-platelet treatment for 10 days
- •Willing to travel to Brookhaven for PET scanning
排除标准
- •Current abuse of or dependence on alcohol or another substance (>6 months remission okay)
- •History of other major psychiatric disorders such as bipolar, schizophrenia, schizoaffective; anorexia or bulimia in past year
- •First degree family history of schizophrenia if subject is under 33
- •Unable/unwilling to discontinue all psychotropic medication that affects the serotonin system
- •Pregnant, breastfeeding, or planning to become pregnant during the study
- •A medical contraindication to antidepressants
- •Prior head trauma with evidence of cognitive impairment
- •Well-documented failure of two or more SSRI AND tricyclic antidepressant (TCA) trials of adequate dose and duration
- •Metal implants, pacemaker, metal protheses or orthodontic appliance, the presence of shrapnel
- •Current past, present, or anticipated exposure to radiation
- •Actively suicidal
- •Lifetime history of glaucoma
- •Lack of response to >2 trials of antidepressant monotherapy of adequate dose and duration
- •Claustrophobia
研究组 & 干预措施
1 - SSRI
Participants will receive standardized pharmacotherapy with the SSRI escitalopram over 8 weeks. Non-remitters after 8 weeks will be offered standardized pharmacotherapy with desipramine
干预措施: Escitalopram (Drug)
1 - SSRI
Participants will receive standardized pharmacotherapy with the SSRI escitalopram over 8 weeks. Non-remitters after 8 weeks will be offered standardized pharmacotherapy with desipramine
干预措施: Desipramine (Drug)
结局指标
主要结局
Remission of Depressive Symptoms
时间窗: Measured at Week 8
Remission in this study is defined as both a ≥50% decrease in the 24-item Hamilton Depression Rating Scale (HDRS) Score and a final 24-item HDRS score \<10. Remission of depressive symptoms was calculated for the 28 completers of the SSRI phase.
次要结局
- Remission of Depressive Symptoms - Tricyclic Phase(Measured over 8 weeks)
- Improvement in Scores on the Hamilton Depression Rating Scale - SSRI Phase(Measured at Week 8)
研究者
Jeffrey Miller
assistant professor of clinical psychiatry
New York State Psychiatric Institute