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

NCT06139016 | Enrolling By Invitation FDA Device

• 2 other identifiers: 2000036184000
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Conditions

Depression

Keywords

ketamine; esketamine; virtual reality

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• Change in 5-Dimensional Altered States of Consciousness Questionnaire (5D-ASC) subscale scores

  baseline, during VR treatment and Immediately post-VR treatment

• Change in 5D-ASC total score

  baseline, during VR treatment and Immediately post-VR treatment

• Change in The Clinician-Administered Dissociative States Scale (CADSS)

  baseline, 40 minutes and immediately post VR treatment

• Change in participant experience

  baseline, during VR treatment and Immediately post-VR treatment

• Change in level of relaxation

  baseline, during VR treatment and Immediately post-VR treatment

Study Arms (1)

Treatment group

EXPERIMENTAL

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

Device: Virtual reality

Interventions

Virtual reality 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

Treatment group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Yale Psychiatry Hospital Interventional Psychiatry Services (IPS) unit

New Haven, Connecticut, 06520, United States

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Sina Nikayin, MD

  Assistant Professor, Departement of Psychiatry, Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2023
• First Posted: November 18, 2023
• Study Start: July 11, 2024
• Primary Completion: June 1, 2025
• Study Completion: December 1, 2025
• Last Updated: March 4, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)