Stony Brook Medicine Anti-Inflammatory Trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 42
- 主要终点
- Change from Baseline Hamilton Depression Rating Scale (HAM-D 24) Score at 8 Weeks
研究概览
简要总结
This is an experimental study designed to measure the effect of celecoxib or minocycline on depressive symptoms in unipolar and bipolar depression. Participants will be equally randomized to either celecoxib or minocycline. All participants will complete a battery of clinical and psychological assessments prior to treatment assignment, and again after treatment completion, to assess any changes or improvements in depression.
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
- 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
- •Current consent form signed
- •Capacity to give informed consent
- •Age range 18-65 (inclusive)
- •Diagnosis of MDD or bipolar depression and currently in a major depressive episode
- •Score of at least 29 on the MADRS (at least moderate depression)
排除标准
- •Hypersensitivity to celecoxib, minocycline, tetracyclines, sulfonamides, aspirin, other NSAIDs, or any component of the formulation; previous asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs
- •History of myocardial infarction or current cardiac condition
- •Heptic impairment, heart failure, severe renal impairment, recent GI bleed, history of peptic ulcer disease, anemia or any other contraindication for celecoxib or minocycline
- •Poor CYP2C9 metabolizer
- •Currently taking medications that interact with celecoxib (digoxin, antihypertensives, diuretics, anticoagulant or anti-platelet treatment, including aspirin), or minocycline (isotretinoin, ergot alkaloids) without providing physicians approval
- •Use of herbs, drugs, or medications with anti-inflammatory or immunomodulatory properties (within 5 half-lives of starting celecoxib or minocycline treatment)
- •Unlikely to tolerate medication washout or the medication-free period following washout.
- •Participant considered at significant risk for suicide.
- •Electroconvulsive therapy (ECT) within 1 month
- •High potential for excessive drug/alcohol use during the treatment period (excluding nicotine or cannabis)
- •Significant active physical illness or neurological deficit that may affect brain functioning.
- •If participant is currently pregnant, breastfeeding, or planning to conceive during the course of study participation.
- •Need for medications that control mania.
研究组 & 干预措施
Celecoxib Arm
Participants will take 400mg (two 200mg tablets) of celecoxib daily with a meal for 8 weeks.
干预措施: Celecoxib (Drug)
Minocycline
Participants will take minocyline for 8 weeks. Dosing of minocycline will gradually increase from 50 mg per day during Week 1, increase to 50 mg b.i.d. during Week 2, and finally reach 100 mg b.i.d. during Weeks 3-8.
干预措施: Minocycline (Drug)
结局指标
主要结局
Change from Baseline Hamilton Depression Rating Scale (HAM-D 24) Score at 8 Weeks
时间窗: Baseline and 8 weeks.
Participants will have a Hamilton Depression Rating Scale-24 (HDRS) score obtained at baseline. Minimum score 0, maximum possible score 75; the higher the score on the scale, the more severe the degree of depression. After eight weeks of medication treatment, the HDRS score will be reevaluated with the HDRS-24. Participants who have a 50% or greater decrease in their HDRS-24 score will be considered responders (to treatment).
次要结局
未报告次要终点
研究者
Ramin Parsey
Principle Investigator (M.D., Ph.D.)
Stony Brook University