Ketamine Therapy in Obsessive-compulsive Disorder and Its Effects on Neuropsychological Function Under Stress in a Cross-over Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change of OCD symptoms (Y-BOCS)
研究概览
简要总结
The main goal of this trial is to demonstrate therapeutic efficacy of low dose ketamine in patients with OCD. We expect that ketamine will alleviate symptoms in the hours following application, but also - if effective - that the anti-OCD effects might last for several days after a single infusion.
详细描述
This study will apply a randomized, double blind, comparator-controlled cross-over design and will be conducted at the Department of Psychiatry and Psychotherapy of the Medical University of Vienna. We will include 30 participants with a primary diagnosis of OCD. Participants will undergo ketamine and comparator infusions in either inpatient- or outpatient settings to assess the therapeutic capabilities of ketamine in OCD. Furthermore, participants' neurocognitive function and stress responses will be tested with four neurocognitive tasks and a cold pressor test paradigm. Also EEG measurements will take place during and before infusions in this phase. Study subjects will be given an option to participate in an open-label follow up with up to 8 infusions over a period of a month. Open-label ketamine treatment will be compared to treatment as usual. After finishing open label treatment an additional EEG measurement will take place.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary diagnosis of obsessive-compulsive disorder
- •A score of 16 or higher on the Yale-Brown Obsessive Compulsive Scale and ability to provide written informed consent
- •At least one previous treatment for OCD
- •Exclusion Criteria Experimental Group:
- •Any history of current or past psychotic disorder
- •A manic episode within the preceding three years
- •Current or unstable remitted substance abuse or dependence except nicotine
- •Pregnancy or elevated risk of becoming pregnant during study duration (desire to have children) and refusal to utilize a proper method of contraception
- •Any current severe personality disorder except comorbid anankastic personality disorder
- •Morbus Raynaud
- •Inability to follow the study protocol or adhere to operational requirements
- •Current and unstable suicidality
- •Unstable hypertension
- •Untreated hyperthyroidism
- •Any unstable cardiovascular disease
- •Untreated disorders severely affecting the HPA-axis (M.Addison, M.Cushing)
- •Current pharmacological therapy severely affecting the HPA-axis like corticosteroids or ACTH
- •Exclusion Criteria Treatment as Usual Group:
- •Any history of current or past psychotic disorder
- •A manic episode within the preceding three years
- •Current or unstable remitted substance abuse or dependence except nicotine
- •Any current severe personality disorder except comorbid anankastic personality disorder
- •Current and unstable suicidality
排除标准
- 未提供
研究组 & 干预措施
Ketamine
Participants will undergo one infusion of ketamine as active comparator. (R,S-ketamine 50mg/ml solution for injection, dose: 0,5 mg per kg bodyweight) Both medications will be diluted in 100 ml saline and will be adjusted for infusion over 40 minutes, administered with a syringe pump.
干预措施: Ketamine 50 MG/ML Blinded (Drug)
Ketamine
Participants will undergo one infusion of ketamine as active comparator. (R,S-ketamine 50mg/ml solution for injection, dose: 0,5 mg per kg bodyweight) Both medications will be diluted in 100 ml saline and will be adjusted for infusion over 40 minutes, administered with a syringe pump.
干预措施: Ketamine 50 MG/ML Open Label (Drug)
Midazolam
Participants will undergo one infusion of midazolam as comparator. (0,045 mg/kg bodyweight) Both medications will be diluted in 100 ml saline and will be adjusted for infusion over 40 minutes, administered with a syringe pump.
干预措施: Midazolam (Drug)
Treatment as Usual
Participants will receive standard-of-care treatment-which may include psychotherapy, pharmacotherapy, physiotherapy, ergotherapy, or a combination of these-at the discretion of the treating physician, independently of the study.
干预措施: Treatment as Usual (TAU) (Other)
结局指标
主要结局
Change of OCD symptoms (Y-BOCS)
时间窗: In total 7 YBOCS assessments will take place between week 1 and 5.
There will be a change of severity of obsessive and compulsive symptoms seven days after ketamine infusion compared to midazolam infusion as measured with the Yale-Brown Obsessive Compulsive Scale (Y-BOCS; score range 0-40, with higher scores indicating greater severity).
次要结局
- Change of OCD symptoms (OCD-VAS)(in each arm 1 week after the infusion)
- Change of OCD symptoms (Y-BOCS)(in each arm 24 hours after infusion)
- Change in neuropsychological function(in each arm 24 hours after infusion)
- Change in cortisol response(in each arm 24 hours after infusion)
- Change of vegetative stress response (heart rate)(in each arm 24 hours after infusion)
- Change of vegetative stress response (blood pressure)(in each arm 24 hours after infusion)
- Change of vegetative stress response (stress VAS)(in each arm 24 hours after infusion)
- Change in OCD symptoms (OCD-VAS)(One month after start of open-label treatment)
- Change in OCD symptoms (YBOCS)(One month after start of open-label treatment)
- Changes in EEG frequency bands(EEG measurements will take place before (5 minutes resting state EEG) and during both infusions of the blinded phase as well as after the open label phase (10 minutes resting state and 5 minutes vigilance EEG).)
研究者
Christoph Kraus
Ap. Prof. PD
Medical University of Vienna