NCT00295347已完成不适用
Mineralocorticoid Receptor in the Treatment of Severe Depression: A Randomized, Double Blind, and Placebo Controlled Trial
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 2
研究概览
简要总结
The proposed research aims to compare the onset of action and the efficacy of fludrocortisone, a mineralocorticoid receptor agonist vs. spironolactone, a mineralocorticoid antagonist, vs. placebo as augmentation to a selective serotonin reuptake inhibitor (SSRI) in 65 inpatients with severe depression. The study will also explore the utility of the hypothalamic-pituitary-adrenal (HPA) axis in predicting treatment response. The study will be a 5-week randomized and double-blind trial of fludrocortisone vs. spironolactone vs. placebo during three years.
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
入排标准
- 年龄范围
- 18 Years 至 70 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Depressed male and female inpatients according to DSM-IV
- •Age between 18 and 70 years
- •Minimum of 17-items Hamilton Depression Score of 18
- •Informed consent signed
排除标准
- •Relevant medical or neurological disorders
- •Pregnancy or unsure contraception
- •Relevant psychiatric comorbidity
- •Active alcohol or other substance abuse/dependance
- •Contraindications to SSRI, fludrocortisone, or spironolactone
- •Steroid medication
研究者
研究点 (2)
Loading locations...
相似试验
进行中(未招募)
不适用
Effects of eplerenone on forearm blood flowhealthy volunteersEUCTR2013-000189-12-NLniversity Medical Centre Nijmegen
已完成
不适用
Effects of the selective mineralocorticoid receptor antagonist eplerenone on extracellular adenosine formation in humans in vivoblood flowischemia reperfusion injury10011082NL-OMON38928niversitair Medisch Centrum Sint Radboud14
已完成
2 期
Steroids and Methotrexate to Treat Systemic VasculitisWegener's GranulomatosisInflammationVasculitisNCT00001256National Institute of Allergy and Infectious Diseases (NIAID)100
尚未招募
2 期
Effects of Mineralocorticoid Receptor Blockade on Metabolism - A Clinical TrialMetabolic and Endocrine - Metabolic disordersDiet and Nutrition - ObesityObesityACTRN12618001958279Dr Moe Thuzar32
进行中(未招募)
1 期
Effects of mineralocorticoid receptor stimulation on cognitive bias and social cognition in patients with major depression and healthy controls: what’s the role of NMDA receptors?depressed patients and healthy control subjectsEUCTR2014-005239-15-DECharité - Universitätsmedizin Berlin232
