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InTRavenous kEtAmine and immerSive virtUal Reality to Treat dEpression

Study acronym: TREASURE
StatusRecruiting
PhasePhase 3
Started
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Record History

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  1. Notable Recruitment opened
    • Study completion pushed from Dec 2027 to Dec 2028
    • Start date changed from estimate of May 2026 to May 3, 2026
    • Site details revised
    v5
  2. Notable Start date: Jan 2026 to May 2026v4
  3. Notable Primary and study completion dates: Nov 2026 to Dec 2027
    • Start date: Mar 2025 to Jan 2026
    v3
  4. Minor Eligibility criteria expanded, about 52 wordsv2
  5. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 Details
NCT Number NCT06781697
Lead Sponsor Sunnybrook Health Sciences Centre
Conditions
(from sponsor)
Treatment Resistant Depression
Related terms Depression, Depressive Disorder, Treatment-Resistant
Enrollment 31 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov