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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 below

Select...

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, during vr treatment and immediately post-vr treatment for reporting.

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 more

VR-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

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Yale UniversityLead Sponsor

1,853 Previous Clinical Trials

2,738,551 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there currently any opportunities for patients to participate in this research project?

"At the present moment, clinicaltrials.gov has determined that this trial is not accepting patient applications; it was initially posted on December 1st 2023 and last modified on November 8th 2023. Nonetheless, there are 1273 additional medical studies actively searching for participants currently."

Answered by AI

What key outcomes are investigators expecting to observe from this medical study?

"The primary goal of this clinical trial, which will be monitored over an extended period involving a baseline and immediately post-VR treatment assessment, is to evaluate the safety of VR treatment via Systematic Assessment of Treatment Emergent Events (SAFTEE). Additional objectives include measuring variations in 5D-ASC total score based on visual analogue scales between 0 and 100 with higher scores indicating greater altered state of consciousness; changes in the Clinician-Administered Dissociative States Scale (CADSS), rated from 0 to 4 by clinicians where higher numbers show more severe symptoms; as well as participant self-reports regarding pleasantness/unpleasantness ranked"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Using Virtual Reality to Control the Audio-visual Inputs During Ketamine/Esketamine Treatment

2024. "Using Virtual Reality to Control the Audio-visual Inputs During Ketamine/Esketamine Treatment". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06139016.

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