InTRavenous kEtAmine and immerSive virtUal Reality to Treat dEpression (TREASURE Trial): a Pilot, Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Feasibility - Number of Participants who Complete at least 90% of Study Follow-ups
研究概览
简要总结
Depression is a common condition, with serious negative effects on the health and quality of life of those affected. While there are currently various medications which attempt to treat depression, they often take a long time to begin to work and do not work at all for many people. There is therefore a need for new treatments which work quickly and effectively.
One such medication is called ketamine. Studies have shown that ketamine can treat symptoms of depression quickly. This quick action sets ketamine apart from many antidepressants that take weeks to show noticeable effects. One way that it may do this is by creating a transient sense or feeling of being separated from reality, such as seeing or hearing things that are not really there. Another way to create these same feelings is with virtual reality (VR), where a person can feel as though they are entering a 3-dimensional virtual computer-generated world by wearing a special headset or goggles with a computer inside.
In this study, all participants will receive standard ketamine treatments for depression. Half of the participants will also use a VR headset while receiving the ketamine treatments to see if ketamine and VR acting together provide a better treatment for symptoms of depression than ketamine alone.
This is a small pilot trial. The main purpose of this trial is to learn if it is possible to run a larger clinical trial comparing "ketamine and VR" with "ketamine alone", for adults with treatment-resistant depression. The researchers will study this by seeing how many participants take part in the study within 1-2 years, and how many complete the study treatments and tests. The researchers will also compare the two study groups to see if "ketamine and VR" provide a better treatment for symptoms of depression than "ketamine alone".
详细描述
Depression is the single largest contributor to global disability, and afflicts individuals of all ages, races, genders, and classes. The significant morbidity is associated with depressive disorders relates to myriad direct and indirect financial costs to individuals and society. It also bears significant mortality, as one of the strongest risk factors for suicide.
Depression is also challenging to treat, with standard antidepressant therapy providing remission to only one third of patients, and incompletely improving the condition of another one third. Even when standard therapy is effective, it can take as long as six weeks for improvement of cognitive/emotional symptoms to become apparent. The final one third of patients often undergo a therapeutic odyssey in which various medications are attempted with no measurable benefit. Ultimately these patients receive a diagnosis of treatment-resistant depression (TRD).
Ketamine has emerged as a fast-acting intervention for the treatment of depressive disorders, which can reach maximum efficacy in only 24 hours and persist for 1-2 weeks. Ketamine is safe, well-tolerated, familiar to many providers and has become widely available as a treatment for depression.
Virtual reality (VR), a technology which immerses users in a controlled digital experience, has also recently been recognized for its potential in the treatment of mental health disorders and recent studies have identified similarities in proposed mechanisms for ketamine and VR in the treatment of depression (e.g. the creation of a non-ordinary and non-rigid experiences of consciousness, and the production of evocative or hallucinatory sensory experiences). However, this combination of interventions has not yet been studied.
Here, the investigators propose to study the combined effect of ketamine and VR in the vulnerable adult mental health population undergoing ketamine therapy for treatment-resistant depression (TRD).
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
- None
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
- •Age ≥ 18, able to provide informed consent
- •Patient diagnosed with treatment-resistant depression
- •Outpatient recommended and approved by psychiatrist for ketamine treatment
- •Patients who are on IV ketamine and requiring at least 4 treatments of IV ketamine per course (prescribed by their physiatrist)
- •Cognitively alert, oriented, and able to watch immersive content and respond to questions
- •Negative human chorionic gonadotropin test before treatment, for female participants of childbearing potential who are not practicing medically appropriate methods of birth control (e.g., hormonal contraceptives, implants, injectables, intrauterine devices, intrauterine systems, etc.)
排除标准
- •History of psychosis/comorbid psychiatric disorders/psychotic depression/dissociative syndromes, significant personality disorder, as clinically assessed by psychiatrist
- •Using non-prescribed substance (e.g., cannabis) or alcohol use within the preceding 48 hours of treatment
- •History of substance misuse and/or dependence, including chronic alcohol abuse
- •Previous ketamine use
- •Acute dementia/delirium
- •Acute risk of suicide at baseline, as determined by the study psychiatrist
- •Pregnancy/breastfeeding
- •Previous sensitivity to ketamine or related compounds
- •Unstable medical condition which may require anesthesia consult
- •History of elevated intracranial pressure or cerebrovascular accident
- •Recent (within 6 weeks) major cardiovascular event (such as myocardial infarction)
- •Significant motion sickness (i.e. occur during exposure to physical/visual and virtual motion, cybersickness, etc.) self-identified by patient
- •Inability to communicate with the study team
研究组 & 干预措施
VR-Ketamine (VR-K)
Participants will receive a standard course of ketamine treatment. At the onset of each ketamine therapy session, participants will be provided with an Oculus VR headset, and will be immersed in a tailor-made virtual environment of positive outdoor scenes.
干预措施: Oculus VR headset (Device)
Ketamine alone
Participants will receive a standard course of ketamine treatment.
干预措施: Ketamine (Drug)
VR-Ketamine (VR-K)
Participants will receive a standard course of ketamine treatment. At the onset of each ketamine therapy session, participants will be provided with an Oculus VR headset, and will be immersed in a tailor-made virtual environment of positive outdoor scenes.
干预措施: Ketamine (Drug)
结局指标
主要结局
Feasibility - Number of Participants who Complete at least 90% of Study Follow-ups
时间窗: From enrolment until the end of follow-ups at 3 months
The number of participants who achieve at least 90% completion of follow-ups in Phase II will be calculated.
Feasibility - Time Required to Complete Enrolment
时间窗: At the time of enrolment
The time required to enrolled to recruit 26 participants in Phase II of the pilot trial will be recorded.
次要结局
- Mood and Psychiatric Outcomes - Montgomery-Åsberg Depression Rating Scale (MADRS)(Baseline, 60 minutes and 24 hours after each treatment, and during 1,2,3-week and 1 and 3 month follow-ups)
- Mood and Psychiatric Outcomes - General Anxiety Disorder-7 (GAD-7)(Baseline, 60 minutes and 24 hours after each treatment, and during 1,2,3-week and 1 and 3 month follow-ups)
- Mood and Psychiatric Outcomes - Positive and Negative Affect Schedule (PANAS)(Baseline, 60 minutes and 24 hours after each treatment, and during 1,2,3-week and 1 and 3 month follow-ups)
- Mood and Psychiatric Outcomes - Patient Health Questionnaire (PHQ-9)(Baseline, 24 hours after each treatment, and during 1,2,3-week and 1 and 3 month follow-ups)
- Mood and Psychiatric Outcomes - Beck Depression Inventory-II (BDI-II)(Baseline, 24 hours after each treatment, and during 1,2,3-week and 1 and 3 month follow-ups)
- Anti-depressant use(Baseline, 1 and 3 month follow-ups)
- Ketamine Side Effects - Heart Rate(Before, continuously during the 45-minute infusion, and up to 60 minutes after each treatment)
- Ketamine Side Effects - Mean Arterial Pressure(Before, continuously during the 45-minute infusion, and up to 60 minutes after each treatment)
- Ketamine Side Effects - Level of consciousness(At baseline, once during the 45-minute infusion, and up to 60 minutes after each treatment)
- Ketamine Side Effects - Dissociative Experiences and Psychotomimetic Side Effects(At baseline, 5-10 minutes after the start of each infusion and 60 minutes after each treatment)
- Ketamine Side Effects - Mystical Experiences Questionnaire (MEQ)(60 minutes after each treatment)
- Ketamine Side Effects - Simulator Sickness Questionnaire(At baseline and 60 minutes after each treatment)
- Cognitive Function - tele-MoCA(Baseline, 1 and 3 month follow-ups)
- Change in EEG Metrics(Before, continuously during the 45-minute infusion, and up to 60 minutes after each treatment)
- Patient Satisfaction - System Usability Scale(60 minutes after the first and final VR-K treatments)
- Patient Satisfaction - Satisfaction Questionnaire(60 minutes after the first and final VR-K treatments)