InTRavenous kEtAmine and immerSive virtUal Reality to Treat dEpression (TREASURE)

This open-label Phase III trial (n=31) will assess the feasibility and efficacy of combining intravenous ketamine (35mg/70kg over 45 minutes) with immersive virtual reality (VR) for the treatment of adults with treatment-resistant depression (TRD).

Conducted by Sunnybrook Health Sciences Centre, the TREASURE trial aims to determine whether VR can enhance the therapeutic effects of ketamine.

In Phase I, a small group (n=3-5) will help refine the VR experience. In Phase II, participants (n=26) will be randomly assigned to receive either standard ketamine treatment alone or ketamine combined with a VR headset displaying calming outdoor scenes. Each participant will receive four ketamine infusions (twice per week for two weeks), with follow-ups assessing mood, anxiety, dissociative effects, cognitive function, and neural activity. The study seeks to inform the development of a larger trial to evaluate the combined treatment’s effectiveness.

Trial Details

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".

Trial Number NCT06781697

Data attribution

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