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| ID | Type | Description | Link |
|---|---|---|---|
| 000 | Other Identifier | CTGTY |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group | Experimental | This single arm will include all participants of the study, who will all receive the intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| 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. Data presented here is the number of participants that stated the treatment was Tolerated. | 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 up to Immediately post-VR treatment |
| Change in Overall Treatment Experience Satisfaction | 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, during and immediately post VR treatment session |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sina Nikayin, MD | Assistant Professor, Departement of Psychiatry, Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale Psychiatry Hospital Interventional Psychiatry Services (IPS) unit | New Haven | Connecticut | 06520 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. Data presented here is the number of participants that stated the treatment was Tolerated. | Posted | Count of Participants | Participants | Immediately post-VR treatment |
|
1 day
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Baseline | Pre-VR data | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Depression | Psychiatric disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sina Nikayin, MD | Yale University | 203-688-9719 | sina.nikayin@yale.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 1, 2024 | May 21, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| 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, during VR 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 0-10 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 |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Education | Count of Participants | Participants |
|
| Diagnosis | Count of Participants | Participants |
|
| Treatment Intervention | Count of Participants | Participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Primary | 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. | Posted | Count of Participants | Participants | baseline up to Immediately post-VR treatment |
|
|
|
| Primary | Change in Overall Treatment Experience Satisfaction | 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. | Data presented here is from participants that completed each assessment. | Posted | Mean | Standard Deviation | score on a scale | Baseline, during and immediately post VR treatment session |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | baseline, during VR treatment and Immediately post-VR treatment |
|
|
|
| Secondary | 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. | Posted | Median | Standard Deviation | score on a scale | baseline, during VR treatment and Immediately post-VR treatment |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | baseline, during VR and immediately post VR treatment |
|
|
|
| Secondary | 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 0-10 with higher scores indicating a more pleasant experience. | 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. | Posted | baseline, during VR treatment and Immediately post-VR treatment |
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | baseline, during VR treatment and Immediately post-VR treatment |
|
|
|
| 7 |
| 0 |
| 7 |
| 6 |
| 7 |
| EG001 | Virtual Reality | During VR data | 0 | 5 | 0 | 5 | 5 | 5 |
| EG002 | Post VR | Post VR treatment data. | 0 | 5 | 0 | 5 | 3 | 5 |
| Headache | Nervous system disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Dizziness/Faintness | Nervous system disorders | Systematic Assessment |
|
| Wobbly | Nervous system disorders | Systematic Assessment |
|
| Unsteadiness | Nervous system disorders | Systematic Assessment |
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| Sound Distortion | Ear and labyrinth disorders | Systematic Assessment |
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| Blurred Vision | Eye disorders | Systematic Assessment |
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| Double Vision | Eye disorders | Systematic Assessment |
|
| Light Sensitivity | Eye disorders | Systematic Assessment |
|
| Drowsiness | Nervous system disorders | Systematic Assessment |
|
| Tiredness/Fatigue | Nervous system disorders | Systematic Assessment |
|
| Nightmares | Psychiatric disorders | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | Systematic Assessment |
|
| Paranoia | Psychiatric disorders | Systematic Assessment |
|
| Dissociation/Dysphoria | Psychiatric disorders | Systematic Assessment |
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| Concentration | Psychiatric disorders | Systematic Assessment |
|
| Early Morning Awakening | Psychiatric disorders | Systematic Assessment |
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| Difficulty Falling Asleep | Psychiatric disorders | Systematic Assessment |
|
| Interrupted Sleep | Psychiatric disorders | Systematic Assessment |
|
| Nasal Congestion | Infections and infestations | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | Systematic Assessment |
|
| Poor Hand Coordination | General disorders | Systematic Assessment |
|
| Left Shoulder Pain | General disorders | Systematic Assessment |
|
| Chronic Back Pain | General disorders | Systematic Assessment |
|
| Back Pain | General disorders | Systematic Assessment |
|
| Dry Nose | General disorders | Systematic Assessment |
|
| Dry Mouth | Gastrointestinal disorders | Systematic Assessment |
|
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| Post VR |
|
|
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| Blissful State |
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| Insightfulness |
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| Disembodiment |
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| Impaired Control and Cognition |
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| Anxiety |
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| Complex Imagery |
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| Elementary Imagery |
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| Audio-Visual Synesthesiae |
|
| Changed Meaning of Percepts |
|