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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-11

Study Completion Date

2025-12-31

Brief Summary

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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

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Detailed Description

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Conditions

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Depression

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment group

This single arm will include all participants of the study, who will all receive the intervention

Group Type EXPERIMENTAL

Virtual reality

Intervention Type DEVICE

Virtual reality gear and content will be used to affect and control the audiovisual perception of patients during a single treatment with ketamine/esketamine

Interventions

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Virtual reality

Virtual reality gear and content will be used to affect and control the audiovisual perception of patients during a single treatment with ketamine/esketamine

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No