Cyclooxygenase-2-Inhibitor Combination Treatment for Bipolar Depression: Role of Inflammation and Kynurenine Pathway Biomarkers
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Response to Treatment
研究概览
简要总结
This project will attempt to enhance and augment the antidepressant efficacy of a commonly used antidepressant in poorly responding bipolar depressed patients.
详细描述
This is a placebo-controlled study of patients with bipolar I disorder (BPD) utilizing a well-known antidepressant, escitalopram (ESC), in combination with the anti-inflammatory agent, celecoxib (CBX). The investigators hypothesize that combination treatment will lead to a qualitatively and quantitatively augmented response and will result in greater numbers of remitters compared to ESC monotherapy.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages 21 - 65 years old at time of screening visit. Both genders and any race will be accepted.
- •Diagnosis of BPD I or II without significant co-morbid secondary medical or psychiatric diagnoses; no substance abuse or dependence during preceding 12 months
- •A minimum score of 18 on the first 17 items of the 21-item Hamilton Depression Scale
- •Willingness to washout for a reasonable time (depending on the substance) from: Vitamin E and fish oils (>600 IU/day), non-aspirin NSAIDs or aspirin (>81 mg/day, H2 receptor antagonists, Ginko biloba, caffeine on morning of blood drawing, and to institute lights-out at 23:00 hours on the nights before blood drawings
排除标准
- •Any abnormal findings on the physical exam, ECG, blood/urine or minor infections
- •Any pre-existing physical pain condition, including fibromyalgia
- •History of peptic ulcer complicated by perforation, hemorrhage, or obstruction; symptoms of peptic ulcer within 4 weeks of enrollment date
- •Any substance abuse or dependence during the preceding 12 months
- •Clinically significant hypertension, anemia, liver disease, kidney disease, arthritis, diabetes, recurrent migraines, epilepsy, stroke, gum disease, autoimmune disease
- •Current use of lithium
- •Current use of a stimulant
- •Certain steroids including use of hormonal birth control and any systemic or topical corticosteroids (hormone replacement therapy will be allowed)
- •Unwillingness to refrain from H2 receptor antagonists, non-aspirin NSAIDs, or aspirin (more than 1 mg/day).
- •Use of any anticoagulant agents
- •Use of nicotine-containing substances. Subjects who quit smoking more than 3 months prior to assessment may be considered for the study
- •Known sensitivity or allergy to the study medications or a need to receive agents that are contra-indicated in combination with CBX or ESC
- •Unwillingness to fast and abstain from caffeine on mornings of blood drawings
- •A sleep disorder other than insomnia or hypersomnia as a distinct symptom of major depressive disorder (MDD)
- •Inability to commit to the follow-up visits between 8 and 11 am
研究组 & 干预措施
Intervention cohort
Participants assigned to the intervention cohort receive 10mg escitalopram twice daily plus 200mg celecoxib twice daily.
干预措施: Escitalopram (Drug)
Intervention cohort
Participants assigned to the intervention cohort receive 10mg escitalopram twice daily plus 200mg celecoxib twice daily.
干预措施: Celecoxib (Drug)
Control cohort
Participants assigned to the control cohort receive 10mg escitalopram twice daily plus placebo administered twice daily.
干预措施: Escitalopram (Drug)
Control cohort
Participants assigned to the control cohort receive 10mg escitalopram twice daily plus placebo administered twice daily.
干预措施: Placebo (Drug)
结局指标
主要结局
Response to Treatment
时间窗: 8 weeks
Participants complete the Hamilton Depression Rating Scale (HDRS-17). The HDRS-17 is a clinician-administered assessment scale measuring the melancholic and physical symptoms of depression. Possible scores range from 0 to 54 (i.e., where higher scores indicate worse depression). In this study, response to treatment is defined as a reduction in the HDRS-17 score of at least 50% after 8 weeks of treatment.
Disease Remission
时间窗: 8 weeks
Participants complete the Hamilton Depression Rating Scale (HDRS-17). The HDRS-17 is a clinician-administered assessment scale measuring the melancholic and physical symptoms of depression. Possible scores range from 0 to 54 (i.e., where higher scores indicate worse depression). In this study, diisease remission is defined as an HDRS-17 score less than 8 points after 8 weeks of treatment.
次要结局
未报告次要终点
研究者
Angelos Halaris
Professor
Loyola University