Virtual reality / Depression · Interventional Study

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

ClinicalTrials.gov · July 31, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a completed but unpublished single-arm feasibility study of virtual reality goggles and noise-cancelling headphones used during ketamine/esketamine treatment for depression in 7 participants. The registry record describes planned outcomes (tolerability, safety, and treatment satisfaction) but does not report any results, precluding assessment of efficacy or effectiveness.

What was studied

Interventional, Single Group, Open label, Treatment purpose. Depression; age from 18 Years. Intervention: Treatment group. n = 7. 1 site: United States.

Key findings

Safety

No results are reported in this registry record; efficacy and safety outcomes remain unpublished. Sample size of 7 is insufficient for quantitative safety or efficacy analysis.

Who this may help

The source did not state who this applies to in practice.

Plain-language summary

This is a completed registry record for a small interventional study (n=7) examining virtual reality during ketamine/esketamine treatment; no results are reported in this registry entry, limiting evidence strength to preliminary pending outcome publication.

Study design

As stated by the source record.

MethodsPrimary outcome measures: Tolerability of VR Treatment Assessed by Qualitative Report (assessed at Immediately post-VR treatment); Safety of VR Treatment Assessed by Systematic Assessment of Treatment Emergent Events (SAFTEE) Assessment (assessed at baseline up to Immediately post-VR treatment); Change in Overall Treatment Experience Satisfaction (assessed at Baseline, during and immediately post VR treatment session)

DesignInterventional, Single Group, Open label, Treatment purpose

PopulationDepression; age from 18 Years

Sample size7

InterventionTreatment group

Setting1 site: United States

Reported figures

Quoted from the source exactly as published.

Planned enrollment7

Recruitment statusCOMPLETED

Primary outcome 1Tolerability of VR Treatment Assessed by Qualitative Report, Immediately post-VR treatment

Primary outcome 2Safety of VR Treatment Assessed by SAFTEE Assessment, baseline up to immediately post-VR treatment

Primary outcome 3Change in Overall Treatment Experience Satisfaction, Baseline, during and immediately post VR treatment session

Caveats

No results are reported in this registry record; efficacy and safety outcomes remain unpublished.
No control arm or comparator group is described; cannot assess VR benefit relative to standard treatment.
Sample size of 7 is insufficient for quantitative safety or efficacy analysis.
Study design features (blinding, randomization, inclusion/exclusion criteria) not detailed in this registry entry.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

limited

Interventional study with no control group mentioned; design details sparse.

Directness

moderate

Directly addresses VR use during ketamine/esketamine treatment in depression.

Consistency

insufficient

Single study; no comparison to other VR or standard ketamine trials reported.

Risk of bias

insufficient

No blinding, randomization, or comparator described in registry record.

Sample adequacy

limited

Only 7 participants enrolled; underpowered for any robust statistical inference.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT06139016). This is a study registration, not published results. Lead sponsor: Yale University. Recruitment status: COMPLETED. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 7 participants (ACTUAL). Conditions: Depression. Interventions: DEVICE: Virtual reality. Primary outcome measures: Tolerability of VR Treatment Assessed by Qualitative Report , Immediately post-VR treatment; Safety of VR Treatment Assessed by Systematic Assessment of Treatment Emergent Events (SAFTEE) Assessment , baseline up to Immediately post-VR treatment; Change in Overall Treatment Experience Satisfaction , Baseline, during and immediately post VR treatment session. Brief summary: Investigators aim to examine the role of audiovisual inputs during treatment with ketamine/esketamine in affecting tolerability and effectiveness of treatment of depressive episodes, by providing patients with a relaxing environment using virtual reality goggles and noise cancelling headphones, and assessing whether these tools can improve the tolerability and effectiveness of treatment with ketamine/esketamine

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

Virtual realityDepressionYale UniversityNCT06139016