Using Virtual Reality to Control the Audio-visual Inputs During Ketamine/Esketamine Treatment (VR-KET)

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

Study Overview

• Status: Enrolling by invitation
• Conditions: Depression
• Intervention / Treatment: Device: Virtual reality

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06520
      • Yale Psychiatry Hospital Interventional Psychiatry Services (IPS) unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment group; This single arm will include all participants of the study, who will all receive the intervention	Device: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tolerability of VR treatment assessed by qualitative report	Tolerability of VR treatment will be assessed by qualitative report, an open-ended question where the participant is allowed to describe any concerns not covered by SAFTEE assessment.	baseline and Immediately post-VR treatment
Safety of VR treatment assessed by Systematic Assessment of Treatment Emergent Events (SAFTEE) assessment	The SAFTEE assessment will be used to assess adverse events during the trial by the number of participants that had any adverse events while on study.	baseline, during VR treatment and Immediately post-VR treatment
Change in overall treatment experience satisfaction between the pre-VR and VR treatment sessions	Efficacy will be assessed by the difference in overall treatment experience satisfaction (via Likert scale) between the pre-VR and VR treatment sessions. Total scores range from 0 to 10 with higher scores indicating higher satisfaction with the treatment experience.	Baseline and immediately post VR treatment session

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in 5-Dimensional Altered States of Consciousness Questionnaire (5D-ASC) subscale scores	The 5D-ASC measures altered states of consciousness and contains 94 items using visual analogue scales. Score for each will be calculated from 0 to 100 based on measurement of where the participant has drawn the line. Then each subscale is the median score from a pre-defined list of items (eg subscale 2 is median of items 9,81,94). Higher scores means more altered state of consciousness.	baseline, during VR treatment and Immediately post-VR treatment
Change in 5D-ASC total score	The 5D-ASC measures altered states of consciousness and contains 94 items (visual analogue scales. Score for each will be calculated from 0 to 100 based on measurement of where the participant has drawn the line. Total score is the median of all items. Higher scores means more altered state of consciousness.	baseline, during VR treatment and Immediately post-VR treatment
Change in The Clinician-Administered Dissociative States Scale (CADSS)	The CADSS is a 23 item structured clinical interview to assess state dissociation rated by clinicians. Each item is scored from 0 (not at all) to 4 (extreme). Total score range from 0-92 with higher scores indicating greater severity of dissociative experiences.	baseline, 40 minutes and immediately post VR treatment
Change in participant experience	Participant experience will be assessed by self report on whether it was a "pleasant vs unpleasant experience"using a Likert scale. Scores from 0-11 with higher scores indicating a more pleasant experience.	baseline, during VR treatment and Immediately post-VR treatment
Change in level of relaxation	The "level of relaxation" will be scored using a Likert scale with total score range from 0 to 11. Higher scores indicate a higher level of relaxation.	baseline, during VR treatment and Immediately post-VR treatment

Collaborators and Investigators

• Sponsor: Yale University
• Investigators: Principal Investigator: Sina Nikayin, MD, Assistant Professor, Departement of Psychiatry, Yale University

Study record dates

Study Major Dates

• Study Start (Actual): July 11, 2024
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: November 3, 2023
• First Submitted That Met QC Criteria: November 8, 2023
• First Posted (Actual): November 18, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 27, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: ketamine; esketamine; virtual reality
• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: 2000036184; 000 (Other Identifier: CTGTY)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No