InTRavenous kEtAmine and immerSive virtUal Reality to Treat dEpression
Recruiting · NCT06781697 · Interventional (participants receive a specific treatment) · Lead sponsor: Sunnybrook Health Sciences Centre
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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".
Who can take part
Inclusion criteria
- 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.)
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
- 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
Where it is running
1 location listed.
- Sunnybrook Health Sciences Centre - Toronto, Ontario, Canada