Mifepristone in Refractory Depression
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Hamilton Depression Rating Scale
研究概览
简要总结
The purpose of the study is to examine the effectiveness of mifepristone treatment in patients with refractory depression. Refractory depression is defined as clinical depression that is unimproved after treatment with at least 2 different antidepressants of adequate dose and time trial. Mifepristone will augment current medications.
详细描述
Study Procedures:
This study will be a double-blind placebo-controlled 5-week trial.
Thirty patients with treatment refractory major depression will be studied over a one year period. Patients will be screened for eligibility, no more than two weeks prior to enrollment, which will involve psychiatric interviews (including the SCID-Mini, HAM-D, BPRS, and CGI-S), a physical exam, and blood and urine analyses.
Clinical laboratory assessments include a serum pregnancy test (for all females), comprehensive blood count, comprehensive metabolic panel, lipid panel, fasting insulin, glucose tolerance test, urine toxicology, and electrocardiogram.
If subjects are found to be eligible, they will be asked return within two weeks of their eligibility screening visit to begin the study. Additionally, they will be asked to keep a diary of their sleep pattern for 1 week prior to entering the study and for the entire 5 week duration of the study.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •21-item HAM-D score of 20 or above.
- •If currently taking antipsychotic, antidepressant, anticonvulsant, and/or mood-stabilizing medications, must be stable on the medication for at least three weeks prior to entering the study.
- •At least 2 failed antidepressant medication trials of adequate dose and duration.
- •Between 18 and 75 years of age.
- •Not currently pregnant or trying to become pregnant.
排除标准
- •History of schizophrenia or other psychotic disorders.
- •Transcranial magnetic stimulation treatment or ECT in the 3 months prior to starting the study.
- •History of vagus nerve stimulation treatment.
- •No unstable or untreated cardiovascular disease, hypertension, or endocrine disorder.
- •Current use of oral contraceptives or any other drug that may result in adverse drug-mifepristone interactions effects (including Amiodarone, Clarithromycin, Erythromycin, Fluconazole, Fluvoxamine, Indinavir, Intraconazole, Ketoconazole, Metronidazole, Miconazole, Nefazodone, Nelfinavir, Norfloxacin, Omeprazole, Quinine, Ritonavir, Saquinavir, Troleandomycin, Zafirlukast, Carbamazepine, Dexamethasone, Ethosuximide, Phenobarbital, Phenytoin, Primidone, Rifabutin, Rifampin, Troglitazone). A 30-day wash-out period for oral contraceptives is required before mifepristone begins.
- •Previous allergic reaction to mifepristone or drugs of similar chemical structure.
研究组 & 干预措施
Mifepristone
Patients received mifepristone for 6 days
干预措施: Mifepristone (Drug)
placebo
Patients received placebo for 6 days
干预措施: Placebo Oral Tablet (Drug)
结局指标
主要结局
Hamilton Depression Rating Scale
时间窗: Baseline and Day 35 HAMD scores
Hamilton Depression Rating Scale. Minimum score of 0 (no depressive symptoms) to maximum of 68 (very severely depressed). Outcome Measure is reporting a Change from Baseline in HAMD scores, i.e., scores at Day 35 minus scores at Baseline.
次要结局
未报告次要终点
研究者
Hugh Brent Solvason
Principle Investigator
Stanford University