Treatment Resistant DepressionPhase 3TREASURENCT06781697
InTRavenous kEtAmine and immerSive virtUal Reality to Treat dEpression
A Phase 3 study testing Ketamine and Oculus VR headset in people with Treatment Resistant Depression, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Treatment Resistant Depression
- What is being tested?
- Ketamine and Oculus VR headset
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteCanada
- Study dates
- 3 May 2026to Dec 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.)
Who cannot join
- 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
- Current or recent (within past twelve months) documented diagnosis of moderate or severe substance use disorder including uncontrolled/active alcohol abuse excepting nicotine or caffeine
- Previous ketamine use
- Acute dementia/delirium
- Acute risk of suicide at baseline, as determined by the study psychiatrist
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
Fahad Alam, MD, (416) 480-4864, fahad.alam@sunnybrook.ca
Peter Giacobbe, MD, (416) 480-4085, peter.giacobbe@sunnybrook.ca
About this study
Official title: InTRavenous kEtAmine and immerSive virtUal Reality to Treat dEpression (TREASURE Trial): a Pilot, Randomized Controlled Trial
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.
Read more
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".
Read the detailed description
Depression is the single largest contributor to global disability, and afflicts individuals of all ages, races, genders, and classes. The significant morbidity is associated with depressive disorders relates to myriad direct and indirect financial costs to individuals and society. It also bears significant mortality, as one of the strongest risk factors for suicide.
Depression is also challenging to treat, with standard antidepressant therapy providing remission to only one third of patients, and incompletely improving the condition of another one third. Even when standard therapy is effective, it can take as long as six weeks for improvement of cognitive/emotional symptoms to become apparent. The final one third of patients often undergo a therapeutic odyssey in which various medications are attempted with no measurable benefit. Ultimately these patients receive a diagnosis of treatment-resistant depression (TRD).
Ketamine has emerged as a fast-acting intervention for the treatment of depressive disorders, which can reach maximum efficacy in only 24 hours and persist for 1-2 weeks. Ketamine is safe, well-tolerated, familiar to many providers and has become widely available as a treatment for depression.
Virtual reality (VR), a technology which immerses users in a controlled digital experience, has also recently been recognized for its potential in the treatment of mental health disorders and recent studies have identified similarities in proposed mechanisms for ketamine and VR in the treatment of depression (e.g. the creation of a non-ordinary and non-rigid experiences of consciousness, and the production of evocative or hallucinatory sensory experiences). However, this combination of interventions has not yet been studied.
Here, the investigators propose to study the combined effect of ketamine and VR in the vulnerable adult mental health population undergoing ketamine therapy for treatment-resistant depression (TRD).
In Phase I of the study, participants (N=3-5) will provide feedback to develop the VR software for this study population.
In Phase II, study participants (N=26) will be randomized to control (standard of care ketamine alone, Group I) or intervention (VR + ketamine concurrently (VR-K), Group II) groups to report on protocol feasibility and to inform the development of a definitive trial to assess VR-K treatment efficacy. All participants will receive a typical sub-anesthetic dose of ketamine (0.5mg/kg) infused intravenously (IV) over 45 minutes, and will be monitored by research staff for up to 90 minutes post-procedure. Each participant will receive a total of 4 ketamine treatments, 2 treatments per week for 2 weeks. All patients will continue their baseline antidepressant regimens while engaged in the study, consistent with standard ketamine therapy for TRD. Participants in the intervention group will wear a virtual reality headset at the onset of each standard ketamine therapy session, and will be immersed in a tailor-made virtual environment of positive outdoor scenes to provide relaxation and reprieve from negative thoughts.
Psychometric surveys will be used to assess the effects of both treatment arms on mood and psychiatric outcomes (depression and anxiety symptoms), side effects (sedation, dissociation, vitals), cognitive function, neural activity (EEG), and patient satisfaction with virtual reality.
- Conditions
- Treatment Resistant Depression
- Being tested
- Ketamine, Oculus VR headset
- Keywords
- Depression, Ketamine, Virtual Reality, Treatment Resistant Depression
- Medical subject headings
- Depressive Disorder, Treatment-Resistant, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetamineDrug
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).
Oculus VR headsetDevice
Immersion in 45 minutes of virtual environments using the Oculus VR headset during each ketamine infusion.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Ketamine; Device: Oculus VR headset |
| Ketamine alone | Active comparator | Participants will receive a standard course of ketamine treatment. Receives: Drug: Ketamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: At the time of enrolment
Secondary outcomes (16)
Mood and Psychiatric Outcomes - Montgomery-Åsberg Depression Rating Scale (MADRS)
The MADRS is a 10-item clinician rated scale for measuring severity in the symptoms of depression. Responses for each item are measured on a scale of 0-6 (from no depressive symptomatology to severe depressive symptoms).
Measured: 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)
A self-reported questionnaire measuring severity of symptoms of anxiety. The total score on the GAD-7 ranges from 0 to 21, with 0 indicating no anxiety and 21 indicating severe anxiety.
Measured: 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)
Self-reported assessment of positive and negative emotions. For positive emotions, scores can range from 10-50, with higher scores representing higher levels of positive affect. For negative emotions, scores can range from 10-50, with lower scores representing lower levels of negative affect.
Measured: 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)
A self-reported 9-item questionnaire to assess degree of depression severity. Total scores can range from 0 to 27, with higher scores indicating more severe depression.
Measured: 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)
Self-reported questionnaire about symptoms of depression, such as mood, self-dissatisfaction, guilt and fatigue. Scores range from 0 to 63, with higher scores representing higher depression severity.
Measured: Baseline, 24 hours after each treatment, and during 1,2,3-week and 1 and 3 month follow-ups
Anti-depressant use
The antidepressant use by participants will be collected.
Measured: Baseline, 1 and 3 month follow-ups
Ketamine Side Effects - Heart Rate
Heart rate will be collected before, during, and up to 60 minutes after each treatment.
Measured: Before, continuously during the 45-minute infusion, and up to 60 minutes after each treatment
Ketamine Side Effects - Mean Arterial Pressure
Mean arterial blood pressure will be collected before, during, and up to 60 minutes after each treatment.
Measured: Before, continuously during the 45-minute infusion, and up to 60 minutes after each treatment
Ketamine Side Effects - Level of consciousness
Participants' level of consciousness will be assessed using the Observer's Assessment of Alertness/Sedation Scale (OAA/S) to establish whether VR engagement is limited by ketamine's effects. The OAA/S score ranges from 1 to 5, with 1 indicating deep sleep/unconsciousness and 5 indicating alertness.
Measured: At baseline, once during the 45-minute infusion, and up to 60 minutes after each treatment
Ketamine Side Effects - Dissociative Experiences and Psychotomimetic Side Effects
The Clinician Administered Dissociative Symptoms Scale (CADSS-6) will be used to assess dissociative experiences and psychotomimetic side effects (i.e., hallucinations, mild depersonalization, derealization, altered time, body perception). Total scores range from 0 to 24, with higher scores indicating higher levels of dissociation.
Measured: At baseline, 5-10 minutes after the start of each infusion and 60 minutes after each treatment
Ketamine Side Effects - Mystical Experiences Questionnaire (MEQ)
A 30-item questionnaire for participants to self-report the degree of dissociative and hallucinogenic experiences during the treatment. Each item is scored 0-5, with 0 indicating "none" and 5 indicating "extreme."
Measured: 60 minutes after each treatment
Ketamine Side Effects - Simulator Sickness Questionnaire
Tolerability of the VR experience will be assessed using the Simulator Sickness Questionnaire (SSQ). Participants will rate the degree to which they experienced 16 symptoms on a scale of 0 to 3, with 0 indicating "not at all" and 3 indicating "severe."
Measured: At baseline and 60 minutes after each treatment
Cognitive Function - tele-MoCA
Any effect of ketamine and VR-K on cognitive function will be assessed using the telephone Montreal Cognitive Assessment (tele-MoCA). Scores range from 0 to 22, with higher scores indicating less cognitive impairment.
Measured: Baseline, 1 and 3 month follow-ups
Change in EEG Metrics
The effect of ketamine and VR-K on neural activity will be assessed using a Muse headband with advanced EEG brain sensors (https://ca.choosemuse.com/products/muse-2). Data will be collected using four EEG channels, two each on the anterior frontal (AF) and temporal-parietal (TP) regions, AF7, AF8, TP9, and TP10. Recordings will include data for five brainwaves: alpha, beta, delta, gamma, and theta. The change in EEG metrics will be assessed throughout each treatment and compared between the two treatment groups. Data will be collected using the Muse Lab software.
Measured: Before, continuously during the 45-minute infusion, and up to 60 minutes after each treatment
Patient Satisfaction - System Usability Scale
Participants in the VR-K group only will be asked to complete a VR system usability scale (VR-SUS) survey for VR technology to evaluate the ease of use of VR technology in this patient population. Participants will indicate their agreement with 8 statements on system usability on a scale of 1-5, with 1 indicating "strongly agree" and 5 indicating "strongly disagree."
Measured: 60 minutes after the first and final VR-K treatments
Patient Satisfaction - Satisfaction Questionnaire
A satisfaction questionnaire surveying participants' subjective thoughts on the procedure experience. The questionnaire will ask participants' level of agreement with 12 statements regarding their experience (5-level scale, from "strongly agree" to "strongly disagree"), as well as ask about participants' preferences regarding video themes/features (open-ended questions).
Measured: 60 minutes after the first and final VR-K treatments
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2025
- Study start3 May 2026
- Primary completionDec 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Treatment Resistant DepressionStudies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A two-phase prospective randomized controlled pilot trial
- Masking
- None (open label)
- Enrolment
- 31 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06781697
- Sponsor's protocol ID
- 6159
- Acronym
- TREASURE
- Status last verified
- Mar 2026
- First submitted
- 19 Dec 2024
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified participant-level data will be made available upon reasonable request to study PI following publication of full trial results.
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- InTRavenous kEtAmine and immerSive virtUal Reality to Treat dEpression (TREASURE Trial): a Pilot, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06781697
- Acronym / sponsor ID
- TREASURE / 6159
- Conditions
- Treatment Resistant Depression
- Keywords
- Depression, Ketamine, Virtual Reality, Treatment Resistant Depression
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 31 participants (estimated)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Study start
- 3 May 2026 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 17 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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".
Detailed description
Depression is the single largest contributor to global disability, and afflicts individuals of all ages, races, genders, and classes. The significant morbidity is associated with depressive disorders relates to myriad direct and indirect financial costs to individuals and society. It also bears significant mortality, as one of the strongest risk factors for suicide.
Depression is also challenging to treat, with standard antidepressant therapy providing remission to only one third of patients, and incompletely improving the condition of another one third. Even when standard therapy is effective, it can take as long as six weeks for improvement of cognitive/emotional symptoms to become apparent. The final one third of patients often undergo a therapeutic odyssey in which various medications are attempted with no measurable benefit. Ultimately these patients receive a diagnosis of treatment-resistant depression (TRD).
Ketamine has emerged as a fast-acting intervention for the treatment of depressive disorders, which can reach maximum efficacy in only 24 hours and persist for 1-2 weeks. Ketamine is safe, well-tolerated, familiar to many providers and has become widely available as a treatment for depression.
Virtual reality (VR), a technology which immerses users in a controlled digital experience, has also recently been recognized for its potential in the treatment of mental health disorders and recent studies have identified similarities in proposed mechanisms for ketamine and VR in the treatment of depression (e.g. the creation of a non-ordinary and non-rigid experiences of consciousness, and the production of evocative or hallucinatory sensory experiences). However, this combination of interventions has not yet been studied.
Here, the investigators propose to study the combined effect of ketamine and VR in the vulnerable adult mental health population undergoing ketamine therapy for treatment-resistant depression (TRD).
In Phase I of the study, participants (N=3-5) will provide feedback to develop the VR software for this study population.
In Phase II, study participants (N=26) will be randomized to control (standard of care ketamine alone, Group I) or intervention (VR + ketamine concurrently (VR-K), Group II) groups to report on protocol feasibility and to inform the development of a definitive trial to assess VR-K treatment efficacy. All participants will receive a typical sub-anesthetic dose of ketamine (0.5mg/kg) infused intravenously (IV) over 45 minutes, and will be monitored by research staff for up to 90 minutes post-procedure. Each participant will receive a total of 4 ketamine treatments, 2 treatments per week for 2 weeks. All patients will continue their baseline antidepressant regimens while engaged in the study, consistent with standard ketamine therapy for TRD. Participants in the intervention group will wear a virtual reality headset at the onset of each standard ketamine therapy session, and will be immersed in a tailor-made virtual environment of positive outdoor scenes to provide relaxation and reprieve from negative thoughts.
Psychometric surveys will be used to assess the effects of both treatment arms on mood and psychiatric outcomes (depression and anxiety symptoms), side effects (sedation, dissociation, vitals), cognitive function, neural activity (EEG), and patient satisfaction with virtual reality.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A two-phase prospective randomized controlled pilot trial
| Arm | Type | Receives |
|---|---|---|
| VR-Ketamine (VR-K) | Experimental | Drug: Ketamine, Device: Oculus VR headsetParticipants 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. |
| Ketamine alone | Active comparator | Drug: KetamineParticipants will receive a standard course of ketamine treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (13 listed)
- 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
- Current or recent (within past twelve months) documented diagnosis of moderate or severe substance use disorder including uncontrolled/active alcohol abuse excepting nicotine or caffeine
- Previous ketamine use
- Acute dementia/delirium
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KetamineStandard-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). | Drug | Ketamine alone, VR-Ketamine (VR-K) |
| Oculus VR headsetImmersion in 45 minutes of virtual environments using the Oculus VR headset during each ketamine infusion. | Device | VR-Ketamine (VR-K) |
Primary outcome
Feasibility - Number of Participants who Complete at least 90% of Study Follow-ups
Time frame: From enrolment until the end of follow-ups at 3 months
The number of participants who achieve at least 90% completion of follow-ups in Phase II will be calculated.
Feasibility - Time Required to Complete Enrolment
Time frame: At the time of enrolment
The time required to enrolled to recruit 26 participants in Phase II of the pilot trial will be recorded.
16 secondary outcomes
Mood and Psychiatric Outcomes - Montgomery-Åsberg Depression Rating Scale (MADRS)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: Baseline, 24 hours after each treatment, and during 1,2,3-week and 1 and 3 month follow-ups
Anti-depressant use
Time frame: Baseline, 1 and 3 month follow-ups
Ketamine Side Effects - Heart Rate
Time frame: Before, continuously during the 45-minute infusion, and up to 60 minutes after each treatment
Ketamine Side Effects - Mean Arterial Pressure
Time frame: Before, continuously during the 45-minute infusion, and up to 60 minutes after each treatment
Ketamine Side Effects - Level of consciousness
Time frame: At baseline, once during the 45-minute infusion, and up to 60 minutes after each treatment
Ketamine Side Effects - Dissociative Experiences and Psychotomimetic Side Effects
Time frame: At baseline, 5-10 minutes after the start of each infusion and 60 minutes after each treatment
Ketamine Side Effects - Mystical Experiences Questionnaire (MEQ)
Time frame: 60 minutes after each treatment
Ketamine Side Effects - Simulator Sickness Questionnaire
Time frame: At baseline and 60 minutes after each treatment
Cognitive Function - tele-MoCA
Time frame: Baseline, 1 and 3 month follow-ups
Change in EEG Metrics
Time frame: Before, continuously during the 45-minute infusion, and up to 60 minutes after each treatment
Patient Satisfaction - System Usability Scale
Time frame: 60 minutes after the first and final VR-K treatments
Patient Satisfaction - Satisfaction Questionnaire
Time frame: 60 minutes after the first and final VR-K treatments
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
- Individual participant dataSharing planned: Yes. De-identified participant-level data will be made available upon reasonable request to study PI following publication of full trial results.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ketamine and Oculus VR headset in people with Treatment Resistant Depression, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fahad Alam, MD (416-480-4864, fahad.alam@sunnybrook.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility - Number of Participants who Complete at least 90% of Study Follow-ups (time frame: From enrolment until the end of follow-ups at 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2026.