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CompletedNot applicableResults posted

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

NCT06139016 · VR-KET · Yale University

Closed to entry
Status
Not accepting participants
Not applicable
Phase
7
Target enrolment
1
Study sites
1 US states

What it is testing

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

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Tolerability of VR Treatment Assessed by Qualitative Report

    Measured over Immediately post-VR treatment

  • Safety of VR Treatment Assessed by Systematic Assessment of Treatment Emergent Events (SAFTEE) Assessment

    Measured over baseline up to Immediately post-VR treatment

  • Change in Overall Treatment Experience Satisfaction

    Measured over Baseline, during and immediately post VR treatment session

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years
Ages
All
Sex
Not accepted
Healthy volunteers
Inclusion Criteria: * Participants must be at least 18 years old * Patients must have completed the acute series of treatment and weekly optimization phases of ketamine/esketamine treatment, and currently receiving continuation/maintenance treatment Written consent for the study procedures * Ability and willingness, in the investigator's judgement, to comply with the study procedure and study requirements. Exclusion Criteria: * Hearing or visual impairment to the degree that would interfere with ability to see or hear VR content. * Difficulty in understanding spoken or written English * Unable to provide informed consent * Dementia or other cognitive disorder or intellectual disability that would impair the subject's ability to understand the study procedure (per investigator judgment) * Any other medical or psychiatric comorbidity that the investigator judges would put the participant at additional undue risk due to study participation or would impair subject's ability to participate in the study. * Was previously enrolled/randomized into the study

Where

1 study site

FacilityCityRegionCountry
Yale Psychiatry Hospital Interventional Psychiatry Services (IPS) unitNew HavenConnecticutUnited States

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

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NCT06139016 on ClinicalTrials.gov →

Last updated in the registry 2026-07-31. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits