InTRavenous kEtAmine and immerSive virtUal Reality to Treat dEpression

Launched by SUNNYBROOK HEALTH SCIENCES CENTRE · Jan 13, 2025

Keywords

ClinConnect Summary

This clinical trial is exploring a new way to treat people with treatment-resistant depression, which means their depression hasn't improved with standard medications. The study is testing whether combining a medication called ketamine with virtual reality (VR) can provide better relief from depression symptoms than ketamine alone. Ketamine has been shown to work quickly for some people, but the researchers want to see if the immersive experience of VR enhances its effects. In this trial, all participants will receive ketamine treatments, and half of them will also use a VR headset during their sessions.

To be eligible for the trial, participants must be at least 18 years old, diagnosed with treatment-resistant depression, and recommended for ketamine treatment by their psychiatrist. They should be able to provide informed consent and respond to questions during the study. However, individuals with certain conditions, such as a history of severe psychiatric disorders or those who are pregnant or recently used substances, will not be able to participate. The trial aims to gather information over the next 1-2 years to see if a larger study comparing the two treatments is feasible. Participants can expect to receive standard care with the potential addition of VR, which might make their treatment experience unique and engaging.

Gender

ALL

Eligibility criteria

• 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