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RecruitingPhase 3

InTRavenous kEtAmine and immerSive virtUal Reality to Treat dEpression

NCT06781697 · TREASURE · Sunnybrook Health Sciences Centre

Recruiting
Status
Accepting participants
Phase 3
Phase
31
Target enrolment
1
Study sites
Outside the US

What it is testing

Summary

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".

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Feasibility - Number of Participants who Complete at least 90% of Study Follow-ups

    Measured over From enrolment until the end of follow-ups at 3 months

  • Feasibility - Time Required to Complete Enrolment

    Measured over At the time of enrolment

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years
Ages
All
Sex
Not accepted
Healthy volunteers
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

1 study site

FacilityCityRegionCountry
Sunnybrook Health Sciences CentreTorontoOntarioCanada

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT06781697 on ClinicalTrials.gov →

Last updated in the registry 2026-08-13. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits