Clinical trial NCT06139016: Using Virtual Reality to Control the Audio-visual Inputs During Ketamine/Esketamine Treatment
Official title: Using Virtual Reality to Control the Audio-visual Inputs During Ketamine/Esketamine Treatment
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Depression
Keywords: ketamine
esketamine
virtual reality
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2023-11-18
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Tolerability of VR treatment assessed by qualitative report
timeFrame: baseline and Immediately post-VR treatment
measure: Safety of VR treatment assessed by Systematic Assessment of Treatment Emergent Events (SAFTEE) assessment
timeFrame: baseline, during VR treatment and Immediately post-VR treatment
measure: Change in overall treatment experience satisfaction between the pre-VR and VR treatment sessions
timeFrame: Baseline and immediately post VR treatment session
Secondary outcomes:
measure: Change in 5-Dimensional Altered States of Consciousness Questionnaire (5D-ASC) subscale scores
timeFrame: baseline, during VR treatment and Immediately post-VR treatment
measure: Change in 5D-ASC total score
timeFrame: baseline, during VR treatment and Immediately post-VR treatment
measure: Change in The Clinician-Administered Dissociative States Scale (CADSS)
timeFrame: baseline, 40 minutes and immediately post VR treatment
measure: Change in participant experience
timeFrame: baseline, during VR treatment and Immediately post-VR treatment
measure: Change in level of relaxation
timeFrame: baseline, during VR treatment and Immediately post-VR treatment
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale Psychiatry Hospital Interventional Psychiatry Services (IPS) unit
state: Connecticut
Study officials:
affiliation: Assistant Professor, Departement of Psychiatry, Yale University
name: Sina Nikayin, MD
role: PRINCIPAL_INVESTIGATOR
References: