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โ† Trials
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InTRavenous kEtAmine and immerSive virtUal Reality to Treat dEpression

RecruitingPhase 3Ages 18 Years - anyAllSunnybrook Health Sciences Centre
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Age โ‰ฅ 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.) Exclusion Criteria: * 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 * Current or recent (within past twelve months) documented diagnosis of moderate or severe substance use disorder including uncontrolled/active alcohol abuse excepting nicotine or caffeine * 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
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What it tests

  • Ketamine
  • Oculus VR headset
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Where

1 site
Sunnybrook Health Sciences Centre
Toronto, Canada
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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