Recruiting
Phase 3

Ketamine & VR

Sponsor:

Sunnybrook Health Sciences Centre

Code:

NCT06781697

Conditions

Treatment Resistant Depression

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Ketamine

Oculus VR headset

Study Details

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".

Conditions

Treatment Resistant Depression

Study ID

NCT06781697

Start date

May 3, 2026

Status verified date

Mar, 2026

Completion date

Dec, 2028

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

31 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: VR-Ketamine (VR-K)

Participants will receive a standard course of ketamine treatment. At the onset of each ketamine therapy session, participants will be provided with an Oculus VR headset, and will be immersed in a tailor-made virtual environment of positive outdoor scenes.

active comparator: Ketamine alone

Participants will receive a standard course of ketamine treatment.

Interventions

Ketamine

Standard-of-care ketamine treatment in the outpatient setting: 0.5 mg/kg IV infused over 45 minutes (with monitoring up to 90 minutes) per session, with 2 sessions per week for 2 weeks (total 4 treatments).

Oculus VR headset

Immersion in 45 minutes of virtual environments using the Oculus VR headset during each ketamine infusion.

Primary outcome measure

  • Feasibility - Number of Participants who Complete at least 90% of Study Follow-ups [ Time Frame: From enrolment until the end of follow-ups at 3 months ]
  • Feasibility - Time Required to Complete Enrolment [ Time Frame: At the time of enrolment ]

Central Contacts and Locations

Central contacts

Fahad Alam, MD

416-480-4864fahad.alam@sunnybrook.ca

Peter Giacobbe, MD

416-480-4085peter.giacobbe@sunnybrook.ca

Locations

Sunnybrook Health Sciences Centre

Recruiting

Toronto, Ontario, Canada, M4N 3M5

Contacts

Fahad Alam, MD

(416) 480-4864fahad.alam@sunnybrook.ca

Peter Giacobbe, MD

(416) 480-4085peter.giacobbe@sunnybrook.ca

More Information

Sponsor

Sunnybrook Health Sciences Centre

Last update posted

Aug 13, 2026

Last verified

Mar, 2026

Keywords

  • Depression
  • Ketamine
  • Virtual Reality
  • Treatment Resistant Depression

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Sunnybrook Health Sciences Centre on 2026-08-13.