Clinical TrialTreatment-Resistant Depression (TRD)KetamineKetamineNot yet recruiting

Intravenous ketamine and immersive virtual reality to treat depression (TREASURE)

Randomized Phase III pilot trial (n=31) comparing standard IV ketamine (0.5 mg/kg over 45 minutes, 4 sessions) versus ketamine with concurrent immersive VR in adults with treatment-resistant depression.

Target Enrollment
31 participants
Study Type
Phase III interventional
Design
Randomized

Detailed Description

This two-phase prospective randomized pilot trial enrols a small development cohort (Phase I, N=3–5) to refine VR content, then randomizes participants (Phase II, N=26) to ketamine alone or ketamine plus immersive VR to assess feasibility and preliminary signals of efficacy for treatment-resistant depression.

All participants receive 0.5 mg/kg IV ketamine infused over 45 minutes, two sessions per week for two weeks (total four treatments). The VR arm wears an Oculus headset during each infusion to experience calming outdoor scenes; outcomes include feasibility, depressive and anxiety symptoms, dissociation/sedation, cognition, EEG measures, and patient satisfaction.

Study Protocol

Preparation

sessions

Dosing

4 sessions
45 min each

Integration

sessions

Study Arms & Interventions

VR + ketamine

experimental

Standard ketamine course with concurrent immersive VR during each infusion.

Interventions

  • Ketamine0.5 mg/kg
    via IV• twice weekly for 2 weeks• 4 doses total

    0.5 mg/kg IV infused over 45 minutes per session

  • Compound
    via Other• per infusion

    Oculus VR headset immersion during each 45-minute ketamine infusion

Ketamine alone

active comparator

Standard ketamine course without VR.

Interventions

  • Ketamine0.5 mg/kg
    via IV• twice weekly for 2 weeks• 4 doses total

    0.5 mg/kg IV infused over 45 minutes per session

Participants

Ages
18 – 99
Sexes
Male & Female

Inclusion Criteria

  • 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

  • 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 Details

Locations

Sunnybrook Health Sciences Centre — Toronto, Ontario, Canada

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