Using Virtual Reality to Control the Audio-visual Inputs During Ketamine/Esketamine Treatment (NCT06139016) | Clinical Trial Compass
CompletedNot Applicable
Using Virtual Reality to Control the Audio-visual Inputs During Ketamine/Esketamine Treatment
United States7 participantsStarted 2024-07-11
Plain-language 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
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Tolerability of VR Treatment Assessed by Qualitative Report
Timeframe: Immediately post-VR treatment
2
Safety of VR Treatment Assessed by Systematic Assessment of Treatment Emergent Events (SAFTEE) Assessment
Timeframe: baseline up to Immediately post-VR treatment
3
Change in Overall Treatment Experience Satisfaction
Timeframe: Baseline, during and immediately post VR treatment session