Open-Label Placebo for the Treatment of Depression
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 主要终点
- v. HAM-D-17 (Hamilton, 1960)
研究概览
简要总结
Open label placebo treatment has been tried for irritable bowel syndrome (Kaptchuk et al, 2010), where three weeks of open label placebo proved superior to a wait-listed control group. Another pilot study demonstrated efficacy in treating children suffering from ADHD with open label placebo treatment (Sandler & Bodfish, 2007). Recent work has shown that placebo openly given can have significant analgesic effects for acute migraines (Kam-Hansen et al, 2014) and for experimentally-induced pain (Schafer at al, 2015). A preliminary attempt to treat depression with open label placebo proved the feasibility of such a study, but was too small and brief for conclusive results (Kelley et al, 2012).
We provide here the protocol for a study to assess the effect of open label placebo treatment for depression.
详细描述
participants will be recruited through advertisements in the traditional and on-line press, and via mental health care workers in local clinics. The psychiatrists in the study team will also have the option to access to the waiting list of outpatient clinics at the Shalvata Mental Health Center, and recruit patients (who's intake appointment in the outpatient clinic is expected to take place in more than 2 months) to the study via phone or face to face in the clinic. If a subject is already taking antidepressant treatment he can be recruited immediately to the study. If a subject is not taking an antidepressant treatment, and in his examination he is diagnosed with depression, the investigator will advice him to approach an outpatient clinic and start taking antidepressant medication. If the subjects refuses to use medications he will be recruited to the study medication-free.
Patients will be invited to participate in the study and the following wording will be used:
"we invite you to participate in a novel mind-body study harnessing placebo effects for the treatment of depression. In the study you will recieve, either immediately or following a waiting period, placebo (inert) tablets. There will be no active component in the tablet, but there is a good chance that it will alleviate some of the depressive symptoms. Furthermore, recent scientific evidence suggests that placebo tablets can initiate healthy responses even if a person knows they are placebos".
Each participant will provide signed informed consent. Each subject will receive a letter to his personal physician or psychiatrist in the community/hospital. Additionally, the study team will also contact the personal physician and inform him of the study. Subjects will continue their psychiatric follow-up and treatment as usual during the whole period of the study. If the study team recognized a suicidal deterioration the personal physician/psychiatrist will be notified immediately via phone. If a subject is currently without psychiatric follow-up, he will examined during the assessment points (every 2 weeks) of the study protocol by one of the physicians of the study team.
Before the first session, each participant will be randomized to one of two possible interventions: either 8 weeks of open label placebo, or 4 weeks of waitlist followed by four weeks of open label placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •i. Major Depressive Episode according to DSM-V ii. Mild to Moderate depression (8>HAM-D-17 <24) iii. Receiving antidepressant medication with no change in medication in the last two weeks or not receiving antidepressants medication
排除标准
- •i. Psychotic depression ii. Agitated depression iii. Bipolar depression iv. Current suicidality or past suicide attempt v. Current drug or alcohol abuse vi. Psychotic disorder vii. Drug and/or alcohol abuse
研究组 & 干预措施
open placebo
8 weeks of open placebo treatment
干预措施: placebo (Drug)
结局指标
主要结局
v. HAM-D-17 (Hamilton, 1960)
时间窗: 8 weeks
次要结局
未报告次要终点
研究者
Ziv Carmel
psychiatrists
Shalvata Mental Health Center