Trial Outcomes & Findings for Using Virtual Reality to Control the Audio-visual Inputs During Ketamine/Esketamine Treatment (NCT NCT06139016)
NCT ID: NCT06139016
Last Updated: 2026-07-31
Results Overview
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. Data presented here is the number of participants that stated the treatment was Tolerated.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
7 participants
Primary outcome timeframe
Immediately post-VR treatment
Results posted on
2026-07-31
Participant Flow
Participant milestones
| Measure |
Treatment Group
This single arm will include all participants of the study, who will all receive the intervention
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
|
|---|---|
|
Overall Study
STARTED
|
7
|
|
Overall Study
COMPLETED
|
5
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Using Virtual Reality to Control the Audio-visual Inputs During Ketamine/Esketamine Treatment
Baseline characteristics by cohort
| Measure |
Treatment Group
n=7 Participants
This single arm will include all participants of the study, who will all receive the intervention
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
|
|---|---|
|
Age, Continuous
|
42.71 years
STANDARD_DEVIATION 14.35 • n=9 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=9 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=9 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=9 Participants
|
|
Education
High School
|
1 Participants
n=9 Participants
|
|
Education
Some College
|
1 Participants
n=9 Participants
|
|
Education
Bachelor's Degree
|
2 Participants
n=9 Participants
|
|
Education
Master's Degree
|
1 Participants
n=9 Participants
|
|
Education
Doctorate Degree
|
2 Participants
n=9 Participants
|
|
Diagnosis
Major Depressive Disorder
|
6 Participants
n=9 Participants
|
|
Diagnosis
Bipolar Disorder
|
1 Participants
n=9 Participants
|
|
Treatment Intervention
Ketamine
|
0 Participants
n=9 Participants
|
|
Treatment Intervention
Esketamine
|
7 Participants
n=9 Participants
|
PRIMARY outcome
Timeframe: Immediately post-VR treatmentTolerability 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. Data presented here is the number of participants that stated the treatment was Tolerated.
Outcome measures
| Measure |
Treatment Group
n=7 Participants
This single arm will include all participants of the study, who will all receive the intervention
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
|
During VR
During VR treatment data.
|
Post VR
Post VR treatment data.
|
|---|---|---|---|
|
Tolerability of VR Treatment Assessed by Qualitative Report
|
4 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: baseline up to Immediately post-VR treatmentThe 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.
Outcome measures
| Measure |
Treatment Group
n=7 Participants
This single arm will include all participants of the study, who will all receive the intervention
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
|
During VR
During VR treatment data.
|
Post VR
Post VR treatment data.
|
|---|---|---|---|
|
Safety of VR Treatment Assessed by Systematic Assessment of Treatment Emergent Events (SAFTEE) Assessment
|
7 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline, during and immediately post VR treatment sessionPopulation: Data presented here is from participants that completed each assessment.
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.
Outcome measures
| Measure |
Treatment Group
n=7 Participants
This single arm will include all participants of the study, who will all receive the intervention
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
|
During VR
During VR treatment data.
|
Post VR
Post VR treatment data.
|
|---|---|---|---|
|
Change in Overall Treatment Experience Satisfaction
Baseline
|
6.29 score on a scale
Standard Deviation 2.75
|
—
|
—
|
|
Change in Overall Treatment Experience Satisfaction
During VR
|
5.8 score on a scale
Standard Deviation 3.49
|
—
|
—
|
|
Change in Overall Treatment Experience Satisfaction
Post VR
|
7.6 score on a scale
Standard Deviation 2.51
|
—
|
—
|
SECONDARY outcome
Timeframe: baseline, during VR treatment and Immediately post-VR treatmentThe 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.
Outcome measures
| Measure |
Treatment Group
n=7 Participants
This single arm will include all participants of the study, who will all receive the intervention
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
|
During VR
n=5 Participants
During VR treatment data.
|
Post VR
n=5 Participants
Post VR treatment data.
|
|---|---|---|---|
|
Change in 5-Dimensional Altered States of Consciousness Questionnaire (5D-ASC) Subscale Scores
Experience of Unity
|
2.92 score on a scale
Standard Deviation 3.93
|
3.64 score on a scale
Standard Deviation 4.47
|
0.44 score on a scale
Standard Deviation 0.50
|
|
Change in 5-Dimensional Altered States of Consciousness Questionnaire (5D-ASC) Subscale Scores
Spiritual Experience
|
3.87 score on a scale
Standard Deviation 4.56
|
6.87 score on a scale
Standard Deviation 8.28
|
0.20 score on a scale
Standard Deviation 0.18
|
|
Change in 5-Dimensional Altered States of Consciousness Questionnaire (5D-ASC) Subscale Scores
Blissful State
|
3.93 score on a scale
Standard Deviation 3.44
|
7.07 score on a scale
Standard Deviation 10.01
|
1.73 score on a scale
Standard Deviation 3.15
|
|
Change in 5-Dimensional Altered States of Consciousness Questionnaire (5D-ASC) Subscale Scores
Insightfulness
|
6.13 score on a scale
Standard Deviation 6.40
|
4.13 score on a scale
Standard Deviation 7.39
|
0.27 score on a scale
Standard Deviation 0.37
|
|
Change in 5-Dimensional Altered States of Consciousness Questionnaire (5D-ASC) Subscale Scores
Disembodiment
|
20.73 score on a scale
Standard Deviation 31.45
|
17.40 score on a scale
Standard Deviation 21.04
|
4.93 score on a scale
Standard Deviation 10.48
|
|
Change in 5-Dimensional Altered States of Consciousness Questionnaire (5D-ASC) Subscale Scores
Impaired Control and Cognition
|
15.80 score on a scale
Standard Deviation 27.30
|
3.46 score on a scale
Standard Deviation 2.71
|
4.00 score on a scale
Standard Deviation 7.75
|
|
Change in 5-Dimensional Altered States of Consciousness Questionnaire (5D-ASC) Subscale Scores
Anxiety
|
19.43 score on a scale
Standard Deviation 30.02
|
6.60 score on a scale
Standard Deviation 11.56
|
0.80 score on a scale
Standard Deviation 0.99
|
|
Change in 5-Dimensional Altered States of Consciousness Questionnaire (5D-ASC) Subscale Scores
Complex Imagery
|
13.40 score on a scale
Standard Deviation 11.65
|
7.07 score on a scale
Standard Deviation 9.86
|
1.13 score on a scale
Standard Deviation 2.17
|
|
Change in 5-Dimensional Altered States of Consciousness Questionnaire (5D-ASC) Subscale Scores
Elementary Imagery
|
12.80 score on a scale
Standard Deviation 11.65
|
2.93 score on a scale
Standard Deviation 5.12
|
2.53 score on a scale
Standard Deviation 3.25
|
|
Change in 5-Dimensional Altered States of Consciousness Questionnaire (5D-ASC) Subscale Scores
Audio-Visual Synesthesiae
|
12.07 score on a scale
Standard Deviation 23.36
|
1.27 score on a scale
Standard Deviation 2.11
|
0.27 score on a scale
Standard Deviation 0.28
|
|
Change in 5-Dimensional Altered States of Consciousness Questionnaire (5D-ASC) Subscale Scores
Changed Meaning of Percepts
|
4.47 score on a scale
Standard Deviation 7.17
|
3.87 score on a scale
Standard Deviation 7.17
|
0.27 score on a scale
Standard Deviation 0.28
|
SECONDARY outcome
Timeframe: baseline, during VR treatment and Immediately post-VR treatmentThe 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.
Outcome measures
| Measure |
Treatment Group
n=7 Participants
This single arm will include all participants of the study, who will all receive the intervention
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
|
During VR
n=5 Participants
During VR treatment data.
|
Post VR
n=5 Participants
Post VR treatment data.
|
|---|---|---|---|
|
Change in 5D-ASC Total Score
|
4.5 score on a scale
Standard Deviation 8.95
|
0.8 score on a scale
Standard Deviation 0.83
|
0.2 score on a scale
Standard Deviation 0.44
|
SECONDARY outcome
Timeframe: baseline, during VR and immediately post VR treatmentThe 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.
Outcome measures
| Measure |
Treatment Group
n=7 Participants
This single arm will include all participants of the study, who will all receive the intervention
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
|
During VR
n=5 Participants
During VR treatment data.
|
Post VR
n=5 Participants
Post VR treatment data.
|
|---|---|---|---|
|
Change in The Clinician-Administered Dissociative States Scale (CADSS)
|
11.2 score on a scale
Standard Deviation 17.51
|
3 score on a scale
Standard Deviation 3.67
|
1.4 score on a scale
Standard Deviation 1.67
|
SECONDARY outcome
Timeframe: baseline, during VR treatment and Immediately post-VR treatmentPopulation: This outcome is a duplicate of the primary Satisfaction outcome that was erroneously repeated as a secondary outcome. This data was only collected and presented once as the primary outcome.
Participant experience will be assessed by self report on whether it was a "pleasant vs unpleasant experience"using a Likert scale. Scores from 0-10 with higher scores indicating a more pleasant experience.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: baseline, during VR treatment and Immediately post-VR treatmentThe "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.
Outcome measures
| Measure |
Treatment Group
n=7 Participants
This single arm will include all participants of the study, who will all receive the intervention
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
|
During VR
n=5 Participants
During VR treatment data.
|
Post VR
n=5 Participants
Post VR treatment data.
|
|---|---|---|---|
|
Change in Level of Relaxation
|
5.71 score on a scale
Standard Deviation 3.15
|
5.8 score on a scale
Standard Deviation 3.27
|
6.8 score on a scale
Standard Deviation 2.51
|
Adverse Events
Baseline
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Virtual Reality
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Post VR
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Baseline
n=7 participants at risk
Pre-VR data
|
Virtual Reality
n=5 participants at risk
During VR data
|
Post VR
n=5 participants at risk
Post VR treatment data.
|
|---|---|---|---|
|
General disorders
Left Shoulder Pain
|
14.3%
1/7 • 1 day
|
0.00%
0/5 • 1 day
|
0.00%
0/5 • 1 day
|
|
General disorders
Chronic Back Pain
|
0.00%
0/7 • 1 day
|
0.00%
0/5 • 1 day
|
20.0%
1/5 • 1 day
|
|
General disorders
Back Pain
|
14.3%
1/7 • 1 day
|
0.00%
0/5 • 1 day
|
0.00%
0/5 • 1 day
|
|
General disorders
Dry Nose
|
14.3%
1/7 • 1 day
|
0.00%
0/5 • 1 day
|
0.00%
0/5 • 1 day
|
|
Gastrointestinal disorders
Dry Mouth
|
0.00%
0/7 • 1 day
|
0.00%
0/5 • 1 day
|
20.0%
1/5 • 1 day
|
|
Psychiatric disorders
Nightmares
|
14.3%
1/7 • 1 day
|
0.00%
0/5 • 1 day
|
0.00%
0/5 • 1 day
|
|
Psychiatric disorders
Anxiety
|
28.6%
2/7 • 1 day
|
0.00%
0/5 • 1 day
|
0.00%
0/5 • 1 day
|
|
Psychiatric disorders
Paranoia
|
14.3%
1/7 • 1 day
|
20.0%
1/5 • 1 day
|
0.00%
0/5 • 1 day
|
|
Psychiatric disorders
Dissociation/Dysphoria
|
14.3%
1/7 • 1 day
|
0.00%
0/5 • 1 day
|
0.00%
0/5 • 1 day
|
|
Psychiatric disorders
Concentration
|
28.6%
2/7 • 1 day
|
20.0%
1/5 • 1 day
|
20.0%
1/5 • 1 day
|
|
Psychiatric disorders
Early Morning Awakening
|
14.3%
1/7 • 1 day
|
0.00%
0/5 • 1 day
|
0.00%
0/5 • 1 day
|
|
Psychiatric disorders
Difficulty Falling Asleep
|
28.6%
2/7 • 1 day
|
0.00%
0/5 • 1 day
|
20.0%
1/5 • 1 day
|
|
Psychiatric disorders
Interrupted Sleep
|
14.3%
1/7 • 1 day
|
20.0%
1/5 • 1 day
|
20.0%
1/5 • 1 day
|
|
Infections and infestations
Nasal Congestion
|
14.3%
1/7 • 1 day
|
0.00%
0/5 • 1 day
|
0.00%
0/5 • 1 day
|
|
Gastrointestinal disorders
Constipation
|
14.3%
1/7 • 1 day
|
0.00%
0/5 • 1 day
|
0.00%
0/5 • 1 day
|
|
General disorders
Poor Hand Coordination
|
14.3%
1/7 • 1 day
|
0.00%
0/5 • 1 day
|
0.00%
0/5 • 1 day
|
|
Ear and labyrinth disorders
Sound Distortion
|
0.00%
0/7 • 1 day
|
20.0%
1/5 • 1 day
|
0.00%
0/5 • 1 day
|
|
Eye disorders
Blurred Vision
|
42.9%
3/7 • 1 day
|
40.0%
2/5 • 1 day
|
20.0%
1/5 • 1 day
|
|
Eye disorders
Double Vision
|
14.3%
1/7 • 1 day
|
20.0%
1/5 • 1 day
|
20.0%
1/5 • 1 day
|
|
Eye disorders
Light Sensitivity
|
14.3%
1/7 • 1 day
|
20.0%
1/5 • 1 day
|
20.0%
1/5 • 1 day
|
|
Nervous system disorders
Drowsiness
|
0.00%
0/7 • 1 day
|
40.0%
2/5 • 1 day
|
0.00%
0/5 • 1 day
|
|
Nervous system disorders
Tiredness/Fatigue
|
42.9%
3/7 • 1 day
|
0.00%
0/5 • 1 day
|
40.0%
2/5 • 1 day
|
|
Psychiatric disorders
Depression
|
42.9%
3/7 • 1 day
|
40.0%
2/5 • 1 day
|
20.0%
1/5 • 1 day
|
|
Nervous system disorders
Headache
|
42.9%
3/7 • 1 day
|
20.0%
1/5 • 1 day
|
0.00%
0/5 • 1 day
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/7 • 1 day
|
40.0%
2/5 • 1 day
|
0.00%
0/5 • 1 day
|
|
Nervous system disorders
Dizziness/Faintness
|
14.3%
1/7 • 1 day
|
0.00%
0/5 • 1 day
|
0.00%
0/5 • 1 day
|
|
Nervous system disorders
Wobbly
|
0.00%
0/7 • 1 day
|
20.0%
1/5 • 1 day
|
0.00%
0/5 • 1 day
|
|
Nervous system disorders
Unsteadiness
|
14.3%
1/7 • 1 day
|
20.0%
1/5 • 1 day
|
0.00%
0/5 • 1 day
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place