Ketamine for the treatment of depressive and negative symptoms in patients with schizophrenia: a randomized controlled cross-over pilot study.
概览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change from baseline in Brief Negative Symptoms Scale (BNSS) scores after two weeks of treatment with esketamine or active placebo (diphenhydramine)
概览
简要总结
To show that esketamine is superior to placebo in reducing negative and depressive symptoms in patients with a psychotic disorder
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •DSM-5 diagnosis of schizophrenia according to SCID 5
- •Minimum Brief Negative Symptom Scale (BNSS (1) score of 39 (at least moderate severity across all items) or
- •Minimum score of 22 on the Montgomery-Åsberg Depression Rating Scale (MADRS) (2)
- •Age: 18 to 65 years
- •Ability to provide written informed consent
- •On stable psychopharmacological medication for at least four weeks prior to study inclusion
- •Female patients of childbearing potential need to utilize a proper method of contraception (pill, vaginal ring, hormonal patch, intrauterine device, cervical cap, condom, contraceptive injection, diaphragm)
排除标准
- •Severe or unstable medical or neurologic disorders or clinically significant abnormality on laboratory screening results
- •Presence of ferromagnetic metal in the body or heart pacemaker
- •Clinically relevant abnormalities in the electro-cardiogram (ECG)
- •History of myocardial infarction, angina pectoris, or paroxysmal hypertensive states
- •Untreated or unstable arterial hypertension
- •Established diagnosis of advanced arteriosclerosis or hyperthyroidism
- •Intolerance to Ketanest® or Dibondrin®
- •Pregnancy or lactation
- •Current antidepressant treatment (or treatment up to two weeks prior to inclusion) with an irreversible MAO-inhibitor (e.g. tranylcypromine)
- •Acute suicidal or homicidal ideation
结局指标
主要结局
Change from baseline in Brief Negative Symptoms Scale (BNSS) scores after two weeks of treatment with esketamine or active placebo (diphenhydramine)
Change from baseline in Brief Negative Symptoms Scale (BNSS) scores after two weeks of treatment with esketamine or active placebo (diphenhydramine)
Change from baseline in Montgomery-Asberg Depression Rating Scale (MADRS) scores after two weeks of treatment with esketamine or active placebo
Change from baseline in Montgomery-Asberg Depression Rating Scale (MADRS) scores after two weeks of treatment with esketamine or active placebo
次要结局
未报告次要终点
研究者
Division of General Psychiatry
Scientific
Medical University Of Vienna