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Virtual Reality for Depression (VR-KET Trial)
N/A
Waitlist Available
Led By Sina Nikayin, MD
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients must have completed the acute series of treatment and weekly optimization phases of ketamine/esketamine treatment, and currently receiving continuation/maintenance treatment
Participants must be at least 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 40 minutes and immediately post vr treatment
Awards & highlights
VR-KET Trial Summary
This trial will test if virtual reality and noise cancelling headphones can improve the effectiveness and tolerability of ketamine/esketamine for treating depression.
Who is the study for?
This trial is for adults over 18 who are already receiving maintenance treatment for depression with ketamine/esketamine. They must be able to understand English, provide consent, and follow study procedures. It's not suitable for those with hearing or visual impairments that prevent VR use, cognitive disabilities, or other conditions that could increase risk or affect participation.Check my eligibility
What is being tested?
The study tests if using virtual reality to create a calming environment during ketamine/esketamine treatments can make the process more tolerable and effective in treating depression. Participants will wear VR goggles and noise-cancelling headphones during their regular treatment sessions.See study design
What are the potential side effects?
While the side effects of virtual reality are generally mild and may include dizziness or nausea, the primary treatment involving ketamine/esketamine can cause dissociation, elevated blood pressure, drowsiness, nausea, and potential addiction.
VR-KET Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have finished the initial and weekly ketamine treatments and am now on a maintenance plan.
Select...
I am 18 years old or older.
VR-KET Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, during vr treatment and immediately post-vr treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, during vr treatment and immediately post-vr treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in overall treatment experience satisfaction between the pre-VR and VR treatment sessions
Safety of VR treatment assessed by Systematic Assessment of Treatment Emergent Events (SAFTEE) assessment
Tolerability of VR treatment assessed by qualitative report
Secondary outcome measures
Change in 5-Dimensional Altered States of Consciousness Questionnaire (5D-ASC) subscale scores
Change in 5D-ASC total score
Change in The Clinician-Administered Dissociative States Scale (CADSS)
+2 moreVR-KET Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment groupExperimental Treatment1 Intervention
This single arm will include all participants of the study, who will all receive the intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Virtual reality
2020
N/A
~1890
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Who is running the clinical trial?
Yale UniversityLead Sponsor
1,863 Previous Clinical Trials
2,742,571 Total Patients Enrolled
63 Trials studying Depression
20,636 Patients Enrolled for Depression
Sina Nikayin, MDPrincipal InvestigatorAssistant Professor, Departement of Psychiatry, Yale University
1 Previous Clinical Trials
34 Total Patients Enrolled
1 Trials studying Depression
34 Patients Enrolled for Depression
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