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NOT YET RECRUITING
NCT06781697
PHASE3

InTRavenous kEtAmine and immerSive virtUal Reality to Treat dEpression

Sponsor: Sunnybrook Health Sciences Centre

View on ClinicalTrials.gov

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".

Official title: InTRavenous kEtAmine and immerSive virtUal Reality to Treat dEpression (TREASURE Trial): a Pilot, Randomized Controlled Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

31

Start Date

2026-05

Completion Date

2027-12

Last Updated

2026-03-16

Healthy Volunteers

No

Interventions

DRUG

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).

DEVICE

Oculus VR headset

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

Locations (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada