InTRavenous kEtAmine and immerSive virtUal Reality to Treat dEpression

NCT06781697 | Not Yet Recruiting Phase 3

• 1 other identifier: 6159
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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

Keywords

Depression; Ketamine; Virtual Reality; Treatment Resistant Depression

Outcome Measures

Primary Outcomes (2)

• Feasibility - Number of Participants who Complete at least 90% of Study Follow-ups

  The number of participants who achieve at least 90% completion of follow-ups in Phase II will be calculated.

  From enrolment until the end of follow-ups at 3 months

• Feasibility - Time Required to Complete Enrolment

  The time required to enrolled to recruit 26 participants in Phase II of the pilot trial will be recorded.

  At the time of enrolment

Secondary Outcomes (16)

• Mood and Psychiatric Outcomes - Montgomery-Åsberg Depression Rating Scale (MADRS)

  Baseline, 60 minutes and 24 hours after each treatment, and during 1,2,3-week and 1 and 3 month follow-ups

• Mood and Psychiatric Outcomes - General Anxiety Disorder-7 (GAD-7)

  Baseline, 60 minutes and 24 hours after each treatment, and during 1,2,3-week and 1 and 3 month follow-ups

• Mood and Psychiatric Outcomes - Positive and Negative Affect Schedule (PANAS)

  Baseline, 60 minutes and 24 hours after each treatment, and during 1,2,3-week and 1 and 3 month follow-ups

• Mood and Psychiatric Outcomes - Patient Health Questionnaire (PHQ-9)

  Baseline, 24 hours after each treatment, and during 1,2,3-week and 1 and 3 month follow-ups

• Mood and Psychiatric Outcomes - Beck Depression Inventory-II (BDI-II)

  Baseline, 24 hours after each treatment, and during 1,2,3-week and 1 and 3 month follow-ups

Study Arms (2)

VR-Ketamine (VR-K)

EXPERIMENTAL

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.

Drug: Ketamine; Device: Oculus VR headset

Ketamine alone

ACTIVE COMPARATOR

Participants will receive a standard course of ketamine treatment.

Drug: Ketamine

Interventions

Ketamine DRUG

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).

Ketamine alone; VR-Ketamine (VR-K)

Oculus VR headset DEVICE

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

VR-Ketamine (VR-K)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.)

You may not qualify if:

• 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

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

MeSH Terms

Conditions

Depressive Disorder, Treatment-Resistant; Depression

Interventions

Ketamine

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Central Study Contacts

Fahad Alam, MD

CONTACT

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

Peter Giacobbe, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A two-phase prospective randomized controlled pilot trial

Study Record Dates

• First Submitted: December 19, 2024
• First Posted: January 17, 2025
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: This is a pilot trial and full inferential analysis will not be conducted until completion of the full trial. As such, data will be available following publication of the primary results of the subsequent full trial.
• Access Criteria: Data and supporting information will be made available following reasonable request directly to study PI.

Locations

CA (1)