Nitrous Oxide - A Novel Therapy for Treatment-Resistant Bipolar Depression
试验速览
- 阶段
- 早期 1 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Change in MADRS (Montgomery Asberg Depression Rating Scale)
研究概览
简要总结
Investigators will study approximately 64 patients with Treatment-Resistant Bipolar Depressive Disorder, defined as a failure of at least 1 antidepressants in the current depressive episode and 2 lifetime medication failures. The study will last approximately 6 to 8 weeks, involving randomization into one of two treatment groups receiving 3 one hour long inhalation treatments over a week.
详细描述
Investigators will study approximately 64 patients with Treatment-Resistant Bipolar Depressive Disorder, defined as a failure of at least 1 antidepressants in the current depressive episode and 2 lifetime medication failures. The study will last approximately 6 to 8 weeks, involving randomization into one of two treatment groups receiving 3 one hour long inhalation treatments over a week. Post-treatment assessments follow each inhalation treatment and are conducted 1 week and 2 weeks following the final inhalation treatment. Patients are then randomized again into the Second Stage of the study, involving the same treatment and post-treatment schedule as the First Stage detailed above.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults 18-65 years of age
- •Treatment-resistant bipolar depressive disorder without psychosis and a MADRS baseline score of >
- •All patients must have history of being on a serum-verified (at time of entry into study) mood stabilizer [lithium at 0.5-1.2mEq/L; or valproic acid, 50-125mcg/ml] for 4 weeks prior to entry into the study and remain on this mood stabilizer during the course of the trial. Further, subjects will have failed two adequate dose/duration antidepressant courses in their lifetime, including one in the current depressive episode (verified by Antidepressant Treatment History Form).
- •Good command of the English language
排除标准
- •Schizophrenia
- •Schizoaffective disorder
- •Obsessive-compulsive disorder or panic disorder
- •Active or recent substance abuse or dependence (in remission at least 1 year prior to the study; exception = nicotine use disorders)
- •A diagnosis of personality disorder that may interfere with the patient's ability to improve on nitrous oxide as determined by study investigator
- •Acute medical illness that may pose subject at risk during nitrous oxide administration (neurological disorders or medical disorders including dementia, stroke, encephalopathy, Parkinson's Disease, brain tumors, multiple sclerosis, seizure disorder, severe cardiac disease, any disease known to affect drug metabolism and excretion, i.e. renal or liver disease) per P.I. discretion
- •Active suicidal intention (inability to contract for safety)
- •Active psychotic symptoms
- •Patients with significant pulmonary disease and/or requiring supplemental oxygen
- •Contraindication against the use of nitrous oxide: pneumothorax; bowel obstruction; middle ear occlusion; elevated intracranial pressure; chronic cobalamin and/or folate deficiency treated with folic acid or vitamin B12; pregnant patients; breastfeeding women; previous administration of NMDA-receptor antagonists (e.g., ketamine); current electro-convulsive therapy treatment
研究组 & 干预措施
Placebo
50% nitrogen {inert}/ 50% oxygen, 3 one hour inhalation treatments per Stage, every other day (M,W,F)
干预措施: Placebo (Drug)
Nitrous Oxide
50% nitrous oxide/ 50% oxygen, 3 one hour inhalation treatments per Stage, every other day (M,W,F)
干预措施: Nitrous Oxide (Drug)
结局指标
主要结局
Change in MADRS (Montgomery Asberg Depression Rating Scale)
时间窗: up to 1 week
Change in depressive symptoms on MADRS scale between baseline and day 7 follow up
次要结局
- Hamilton Depression Rating Scale-17 Item (Ham-D17)(up to1week)
- Young Mania Rating Scale (YMRS) to Assess Emergence of Mania/Hypomania(up to 1 week)