Treatment Resistant Depression / Ketamine / Oculus VR headset · Phase 3 Trial
ClinicalTrials.gov · August 13, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a Phase 3 pilot feasibility registration for a small, actively recruiting study combining intravenous ketamine with immersive virtual reality in adults with treatment-resistant depression. The trial's primary objectives are to determine recruitment rates and study completion rates over 3 months, not to measure clinical efficacy; no results are yet available in this registry record.
Phase 3, Interventional, Randomized, Parallel, Open label, Treatment purpose. Treatment Resistant Depression; age from 18 Years. Intervention: VR-Ketamine (VR-K). Compared with: Ketamine alone — Active Comparator. n = 31. 1 site: Canada.
This is a Phase 3 pilot feasibility registration for a small, actively recruiting study combining intravenous ketamine with immersive virtual reality in adults with treatment-resistant depression. The trial's primary objectives are to determine recruitment rates and study completion rates over 3 months, not to measure clinical efficacy; no results are yet available in this registry record.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
This pilot study is designed to establish whether a larger efficacy trial comparing ketamine plus VR to ketamine alone is feasible and can be conducted. Results, once available, will inform trial design and participant feasibility rather than clinical practice regarding depression treatment.
This is a Phase 3 pilot feasibility study with no results yet reported; it is designed to test recruitment and retention, not to establish efficacy, and enrollment is small and still recruiting.
As stated by the source record.
Quoted from the source exactly as published.
This pilot study is designed to establish whether a larger efficacy trial comparing ketamine plus VR to ketamine alone is feasible and can be conducted. Results, once available, will inform trial design and participant feasibility rather than clinical practice regarding depression treatment.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT06781697). This is a study registration, not published results. Lead sponsor: Sunnybrook Health Sciences Centre. Recruitment status: RECRUITING. Phase: PHASE3. Study type: INTERVENTIONAL. Enrollment: 31 participants (ESTIMATED). Conditions: Treatment Resistant Depression. Interventions: DRUG: Ketamine; DEVICE: Oculus VR headset. Primary outcome measures: Feasibility - Number of Participants who Complete at least 90% of Study Follow-ups , From enrolment until the end of follow-ups at 3 months; Feasibility - Time Required to Complete Enrolment , At the time of enrolment. Brief 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".
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