NCT06781697RecruitingPhase 3
InTRavenous kEtAmine and immerSive virtUal Reality to Treat dEpression
InTRavenous kEtAmine and immerSive virtUal Reality to Treat dEpression (TREASURE Trial): a Pilot, Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 23 Oct 2026
Brief summary (registry, in English)
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".
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 31 (estimated)
- First submitted
- 19 Dec 2024
- Start date
- 3 May 2026
- Primary completion date
- Dec 2027
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Diseases
- Depression
- NCT number
- NCT06781697
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 31
- From 3 May 2026 to the primary completion date, Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous ketamine use
- Previous sensitivity to ketamine or related compounds
Other illness
- History of psychosis/comorbid psychiatric disorders/psychotic depression/dissociative syndromes, significant personality disorder, as clinically assessed by psychiatrist
- 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
- Acute dementia/delirium
- 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)
Other
- Using non-prescribed substance (e.g., cannabis) or alcohol use within the preceding 48 hours of treatment
- Acute risk of suicide at baseline, as determined by the study psychiatrist
- Pregnancy/breastfeeding
- 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
Who the study is looking for
- 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.)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sunnybrook Health Sciences Centre Coordinator of this site? Confirm its status | Toronto | Canada | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.