InTRavenous kEtAmine and immerSive virtUal Reality to Treat dEpression
ConditionTreatment Resistant Depression
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorSunnybrook Health Sciences Centre
About this 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.
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".
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Ketamine
DrugStandard-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 headset
DeviceImmersion in 45 minutes of virtual environments using the Oculus VR headset during each ketamine infusion.
Treatment groups
31 Participants
are divided into 2 treatment groupsGroup A: VR-Ketamine (VR-K)Experimental treatment 2 interventions
Group B: Ketamine aloneActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
From enrolment until the end of follow-ups at 3 months2
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.
Time frame
At the time of enrolmentSecondary outcomes
1
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).
Time frame
Baseline, 60 minutes and 24 hours after each treatment, and during 1,2,3-week and 1 and 3 month follow-ups2
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.
Time frame
Baseline, 60 minutes and 24 hours after each treatment, and during 1,2,3-week and 1 and 3 month follow-ups3
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.
Time frame
Baseline, 60 minutes and 24 hours after each treatment, and during 1,2,3-week and 1 and 3 month follow-ups4
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.
Time frame
Baseline, 24 hours after each treatment, and during 1,2,3-week and 1 and 3 month follow-upsSponsors and contacts
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Source ClinicalTrials.gov