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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

Must not have

Unable to provide informed consent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 40 minutes and immediately post vr treatment

Awards & highlights

No Placebo-Only Group

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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am unable to understand and give consent for treatment.

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.