Stress and Inflammation in the Pathophysiology of Late Life Depression
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 119
- 试验地点
- 1
- 主要终点
- IL-6 Levels
研究概览
简要总结
Over 18% of Americans aged 65 years and older have depression. Recent evidence suggests that there is a link between depression and inflammatory disease. This study investigates the relationship between inflammation in the brain and depression. Comparing biological and psychological differences in depressed and non-depressed people allows researchers to find better ways to treat and prevent depression. All participants will have: neuropsychological tests, an EKG, a spinal tap, a blood draw, and, if depressed, given either an antidepressant coupled with an anti-inflammatory medication or an anti-depressant coupled with a placebo for six weeks. The investigators are trying to correlate brain function with depression levels and biomarkers from the blood and spinal fluid.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18-80, male or female, any race;
- •Absence of clinical dementia
- •English speaking
- •Blood pressure not exceeding 150/90 mmHg, treated or untreated
- •Weight greater than 110 lbs
- •Normal result on liver-function test
- •No history of ulcer disease or GI bleeding
- •No renal insufficiency
- •Additional Inclusion Criteria for Depressed Participants:
- •DSM-IV criteria for Major Depressive Disorder
- •HAM-D greater than 18
排除标准
- •Known history of relevant severe drug allergy or hypersensitivity (e.g. to Citalopram or Escitalopram, and/or to celecoxib, aspirin, or other NSAIDs only for Phase 2; known demonstration of allergic-type reactions to sulfonamides);
- •Does not speak English;
- •Cannot give informed consent;
- •MRI contraindications (e.g., foreign metallic implants, pacemaker);
- •Known primary neurological disorders, such as Parkinson's disease, Alzheimer's disease, traumatic brain injury, cognitive impairment or dementia,
- •Known severe inflammatory disease such as systemic lupus erythematosis, known autoimmune diseases, such as multiple sclerosis, rheumatoid arthritis; Screen + for RF, ANA, HIV, Hepatitis B or C.
- •Clinical Dementia Rating Scale score greater than 0;
- •Diagnosis of a chronic psychiatric illness other than MDD at the discretion of the study doctor;
- •Significant handicaps (e.g. uncorrected hearing or visual impairment, mental retardation) that would interfere with testing;
- •Bleeding diathesis;
- •Severe Medical problem, which in the opinion of the investigator would pose a safety risk to the subject;
- •Clinically significant cardiovascular disease that will be assessed on a case-by-case basis. Clinically significant cardiovascular disease usually includes one or more of the following: cardiac surgery or myocardial infarction within the last 4 weeks; unstable angina; acute decompensated congestive heart failure or class IV heart failure; current significant cardiac arrhythmia or conduction disturbance, particularly those resulting in ventricular fibrillation, or causing syncope or near syncope; uncontrolled high blood pressure; QTc greater than 450msec (by history for subjects with cardiac disease); documented prior stroke;
- •Clinically significant abnormalities on EKG. Primary AV block or Right bundle branch block are not necessarily exclusionary;
- •Current diagnosis of cancer
- •Current diagnosis of HIV, active Hepatitis B and/or Hepatitis C
- •Use of an Investigational medicine within the past 30 days;
- •Use of Coumadin, Warfarin within the past 2 months;
- •Current treatment with psychotropic drugs or drugs that affect the CNS such as beta-blockers, mood stabilizers, antipsychotics, steroids or non-steroidal anti-inflammatory medications or other antidepressants. No subjects will be included in the study unless they have been off all psychotropics for at least 3 weeks, except in the case of fluoxetine, where 5 weeks off treatment will be required;
- •Current alcohol or substance abuse disorder, schizophrenia or other psychotic disorder, bipolar disorder, or current OCD;
- •Abnormal liver-function test
- •History of ulcer disease, Chron's disease, GI bleeding or anemia
- •Weight less than 110 lbs
- •Renal insufficiency
- •Any other factor that in the investigator's judgment may affect patient safety or compliance (e.g. distance greater than 100 miles from this facility);
- •Additional Exclusion Criteria for Depressed Subjects:
- •Active suicidality or current suicidal risk as determined by the investigator
研究组 & 干预措施
Experimental - treatment
Depressed participants will receive an antidepressant (escitalopram) AND either a non-steroidal anti-inflammatory drug (celecoxib) OR placebo (sugar pill) for 6 weeks.
干预措施: Escitalopram + Celecoxib (Drug)
Experimental - treatment
Depressed participants will receive an antidepressant (escitalopram) AND either a non-steroidal anti-inflammatory drug (celecoxib) OR placebo (sugar pill) for 6 weeks.
干预措施: Escitalopram + Placebo (Drug)
结局指标
主要结局
IL-6 Levels
时间窗: up to week 6
IL6 levels were measured in participants by blood draw 6 weeks after the first dose was given.
Montgomery Asberg Depression Rating Scale (MADRS)
时间窗: Week 6
This depression rating scale will be used to determine clinical outcome for depressed participants. Scores range from 0-60. The higher the score, the worse the outcome (see below) Normal: 0-6 Mild Depression: 7-19 Moderate Depression: 20-34 Severe Depression: 35+ Very Severe Depression: 60
IL10 Levels
时间窗: up to 6 weeks
IL10 levels were measured in participants by blood draw 6 weeks after the first dose was given
次要结局
未报告次要终点