Trial Outcomes & Findings for Ketamine Infusion for Social Anxiety Disorder (NCT NCT02083926)

NCT ID: NCT02083926

Last Updated: 2021-03-18

Results Overview

Instrument that tries to measure anxiety, that is believed to range across a continuum of values and cannot easily be directly measured.We used a straight horizontal line of 100 mm in length. The ends were defined as the extreme limits of the parameter to be measured (anxiety); oriented from the left (no anxiety) to the right (worst anxiety ever felt). The patient marks on the line the point that they feel represents their perception of their current state.The VAS score is determined by measuring in millimeters from the left hand end of the line to the point that the patient marks. We examined Visual Analog Scale (VAS) for anxiety symptoms at screening, 1 hour prior to infusion, 1, 2 and 3 hours after infusion, 1, 2, 3, 5, 7, 10, and 14 days following a single ketamine/saline infusion.

Recruitment status

COMPLETED

Study phase

EARLY_PHASE1

Target enrollment

18 participants

Primary outcome timeframe

Day 1 (1+28)

Results posted on

2021-03-18

Participant Flow

Participant milestones

Participant milestones
Measure	Ketamine Infusion on Day 0, Saline Infusion on Day 28 A ketamine infusion was given on day 0 at a dose of 0.5mg/kg over 40 minutes. Assessments were conducted pre-infusion, 3-h post-infusion, and days 1, 2, 3, 5, 7, 10 and 14 post-infusion. A saline infusion was given on Day 28 at a dose of 0.5mg/kg over a 40 minute period. Assessments were conducted pre-infusion, 3-h post-infusion, and days 1+28, 2+28, 3+28, 5+28, 7+28, 10+28 and 14+28 post-infusion.	Saline Infusion on Day 0, Ketamine Infusion on Day 28 A saline infusion was given on day 0 at a dose of 0.5mg/kg over 40 minutes. Assessments were conducted pre-infusion, 3-h post-infusion, and days 1, 2, 3, 5, 7, 10 and 14 post-infusion. A Ketamine infusion was given on Day 28 at a dose of 0.5mg/kg over a 40 minute period. Assessments were conducted pre-infusion, 3-h post-infusion, and days 1+28, 2+28, 3+28, 5+28, 7+28, 10+28 and 14+28 post-infusion.
Overall Study STARTED	9	9
Overall Study COMPLETED	8	9
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Ketamine Infusion on Day 0, Saline Infusion on Day 28 A ketamine infusion was given on day 0 at a dose of 0.5mg/kg over 40 minutes. Assessments were conducted pre-infusion, 3-h post-infusion, and days 1, 2, 3, 5, 7, 10 and 14 post-infusion. A saline infusion was given on Day 28 at a dose of 0.5mg/kg over a 40 minute period. Assessments were conducted pre-infusion, 3-h post-infusion, and days 1+28, 2+28, 3+28, 5+28, 7+28, 10+28 and 14+28 post-infusion.	Saline Infusion on Day 0, Ketamine Infusion on Day 28 A saline infusion was given on day 0 at a dose of 0.5mg/kg over 40 minutes. Assessments were conducted pre-infusion, 3-h post-infusion, and days 1, 2, 3, 5, 7, 10 and 14 post-infusion. A Ketamine infusion was given on Day 28 at a dose of 0.5mg/kg over a 40 minute period. Assessments were conducted pre-infusion, 3-h post-infusion, and days 1+28, 2+28, 3+28, 5+28, 7+28, 10+28 and 14+28 post-infusion.
Overall Study Withdrawal by Subject	1	0

Baseline Characteristics

Ketamine Infusion for Social Anxiety Disorder

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ketamine Infusion on Day 0, Saline Infusion on Day 28 n=9 Participants A ketamine infusion was given on day 0 at a dose of 0.5mg/kg over 40 minutes. Assessments were conducted pre-infusion, 3-h post-infusion, and days 1, 2, 3, 5, 7, 10 and 14 post-infusion. A saline infusion was given on Day 28 at a dose of 0.5mg/kg over a 40 minute period. Assessments were conducted pre-infusion, 3-h post-infusion, and days 1+28, 2+28, 3+28, 5+28, 7+28, 10+28 and 14+28 post-infusion.	Saline Infusion on Day 0, Ketamine Infusion on Day 28 n=9 Participants A saline infusion was given on day 0 at a dose of 0.5mg/kg over 40 minutes. Assessments were conducted pre-infusion, 3-h post-infusion, and days 1, 2, 3, 5, 7, 10 and 14 post-infusion. A Ketamine infusion was given on Day 28 at a dose of 0.5mg/kg over a 40 minute period. Assessments were conducted pre-infusion, 3-h post-infusion, and days 1+28, 2+28, 3+28, 5+28, 7+28, 10+28 and 14+28 post-infusion.	Total n=18 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=5 Participants	9 Participants n=7 Participants	18 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	30.78 years STANDARD_DEVIATION 13.50 • n=5 Participants	28.67 years STANDARD_DEVIATION 8.66 • n=7 Participants	29.72 years STANDARD_DEVIATION 11.05 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	5 Participants n=7 Participants	7 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	4 Participants n=7 Participants	11 Participants n=5 Participants
Race/Ethnicity, Customized Non-Hispanic White	8 Participants n=5 Participants	6 Participants n=7 Participants	14 Participants n=5 Participants
Race/Ethnicity, Customized Non-Hispanic Asian	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment United States	9 participants n=5 Participants	9 participants n=7 Participants	18 participants n=5 Participants
Visual Analogue Scale for anxiety symptoms (VAS-anxiety)	47.22 units on a scale STANDARD_DEVIATION 18.89 • n=5 Participants	57.78 units on a scale STANDARD_DEVIATION 19.70 • n=7 Participants	47.22 units on a scale STANDARD_DEVIATION 18.89 • n=5 Participants
Liebowitz Social Anxiety Score (LSAS)	93.89 units on a scale STANDARD_DEVIATION 19.37 • n=5 Participants	87.44 units on a scale STANDARD_DEVIATION 14.53 • n=7 Participants	90.67 units on a scale STANDARD_DEVIATION 16.94 • n=5 Participants

PRIMARY outcome

Timeframe: Day 1 (1+28)

Outcome measures

Outcome measures
Measure	Ketamine Infusion on Day 0 or Day 28 n=18 Participants A ketamine infusion was given on day 0 or day 28 at a dose of 0.5mg/kg over 40 minutes. Assessments were conducted pre-infusion, 3-h post-infusion, and days 1 (1+28), 2 (2+28), 3 (3+28), 5 (5+28), 7 (7+28), 10 (10+28) and 14 (14+28) post-infusion.	Saline Infusion on Day 0 or Day 28 n=17 Participants A saline infusion was given on day 0 or day 28 at a dose of 0.5mg/kg over 40 minutes. Assessments were conducted pre-infusion, 3-h post-infusion, 1 (1+28), 2 (2+28), 3 (3+28), 5 (5+28), 7 (7+28), 10 (10+28) and 14 (14+28) post-infusion.
Visual Analogue Scale for Anxiety Symptoms (VAS-anxiety)	12.1 units on a scale Standard Deviation 18.6	19.6 units on a scale Standard Deviation 18.5

PRIMARY outcome

Timeframe: Day 1 (1+28)

Clinician-administered scale for the assessment of fear and avoidance found in social phobia (SAD); it has 24 items divided into 2 subscales, 13 for performance anxiety, and 11 for social situations each rated from 0 to 3 (0=none,1=mild,2=moderate,3=definite). The sum scores for Fear and Avoidance results in an overall score (max 144 points). There are 4 clinician subscales: fear of social interaction, fear of performance, avoidance of social interaction and avoidance of performance 0 to 30= SAD is unlikely 30 to 60=SAD is probable 60 to 90=SADis very probable \>90= SAD highly probable

Outcome measures

Outcome measures
Measure	Ketamine Infusion on Day 0 or Day 28 n=18 Participants A ketamine infusion was given on day 0 or day 28 at a dose of 0.5mg/kg over 40 minutes. Assessments were conducted pre-infusion, 3-h post-infusion, and days 1 (1+28), 2 (2+28), 3 (3+28), 5 (5+28), 7 (7+28), 10 (10+28) and 14 (14+28) post-infusion.	Saline Infusion on Day 0 or Day 28 n=17 Participants A saline infusion was given on day 0 or day 28 at a dose of 0.5mg/kg over 40 minutes. Assessments were conducted pre-infusion, 3-h post-infusion, 1 (1+28), 2 (2+28), 3 (3+28), 5 (5+28), 7 (7+28), 10 (10+28) and 14 (14+28) post-infusion.
Liebowitz Social Anxiety Score (LSAS)	66.1 score on a scale Standard Deviation 30.9	86.1 score on a scale Standard Deviation 30

Adverse Events

Ketamine Infusion on Day 0 or Day 28

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Saline Infusion on Day 0 or Day 28

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Dr. Michael H. Bloch

Yale University

Phone: 2037374539

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Other adverse events
Measure	Ketamine Infusion on Day 0 or Day 28 n=18 participants at risk Participants were randomized to receive ketamine either on day 0 or on day 28. The ketamine infusion was given at a dose of 0.5mg/kg over 40 minutes. Assessments were conducted pre-infusion, 3-h post-infusion, and days 1, 2, 3, 5, 7, 10 and 14 post-infusion.	Saline Infusion on Day 0 or Day 28 n=17 participants at risk Participants were randomized to receive a saline infusion either on day 0 or on day 28 at a dose of 0.5mg/kg over 40 minutes. Assessments were conducted pre-infusion, 3-h post-infusion, and days 1, 2, 3, 5, 7, 10 and 14 post-infusion.
Nervous system disorders things seem to be moving	38.9% 7/18 • Number of events 7 • 1 hour after infusion The Clinician-Administered Dissociative State Scale (CADSS) is a 27-item scale. The subjective component consists of 19 clinician administered items that are meant to depict the subjects state at the time that the items are being asked of them. The range of possible responses: 0 = not at all, 1 = slightly, 2= moderately, 3 = considerably, 4 = extremely. The clinician rates the 8 subjective items.	11.8% 2/17 • Number of events 2 • 1 hour after infusion The Clinician-Administered Dissociative State Scale (CADSS) is a 27-item scale. The subjective component consists of 19 clinician administered items that are meant to depict the subjects state at the time that the items are being asked of them. The range of possible responses: 0 = not at all, 1 = slightly, 2= moderately, 3 = considerably, 4 = extremely. The clinician rates the 8 subjective items.
Nervous system disorders things seem unreal	50.0% 9/18 • Number of events 9 • 1 hour after infusion The Clinician-Administered Dissociative State Scale (CADSS) is a 27-item scale. The subjective component consists of 19 clinician administered items that are meant to depict the subjects state at the time that the items are being asked of them. The range of possible responses: 0 = not at all, 1 = slightly, 2= moderately, 3 = considerably, 4 = extremely. The clinician rates the 8 subjective items.	17.6% 3/17 • Number of events 3 • 1 hour after infusion The Clinician-Administered Dissociative State Scale (CADSS) is a 27-item scale. The subjective component consists of 19 clinician administered items that are meant to depict the subjects state at the time that the items are being asked of them. The range of possible responses: 0 = not at all, 1 = slightly, 2= moderately, 3 = considerably, 4 = extremely. The clinician rates the 8 subjective items.
Nervous system disorders feel like you are separated from reality	16.7% 3/18 • Number of events 3 • 1 hour after infusion The Clinician-Administered Dissociative State Scale (CADSS) is a 27-item scale. The subjective component consists of 19 clinician administered items that are meant to depict the subjects state at the time that the items are being asked of them. The range of possible responses: 0 = not at all, 1 = slightly, 2= moderately, 3 = considerably, 4 = extremely. The clinician rates the 8 subjective items.	5.9% 1/17 • Number of events 1 • 1 hour after infusion The Clinician-Administered Dissociative State Scale (CADSS) is a 27-item scale. The subjective component consists of 19 clinician administered items that are meant to depict the subjects state at the time that the items are being asked of them. The range of possible responses: 0 = not at all, 1 = slightly, 2= moderately, 3 = considerably, 4 = extremely. The clinician rates the 8 subjective items.
Nervous system disorders looking at things outside of your body	22.2% 4/18 • Number of events 4 • 1 hour after infusion The Clinician-Administered Dissociative State Scale (CADSS) is a 27-item scale. The subjective component consists of 19 clinician administered items that are meant to depict the subjects state at the time that the items are being asked of them. The range of possible responses: 0 = not at all, 1 = slightly, 2= moderately, 3 = considerably, 4 = extremely. The clinician rates the 8 subjective items.	0.00% 0/17 • 1 hour after infusion The Clinician-Administered Dissociative State Scale (CADSS) is a 27-item scale. The subjective component consists of 19 clinician administered items that are meant to depict the subjects state at the time that the items are being asked of them. The range of possible responses: 0 = not at all, 1 = slightly, 2= moderately, 3 = considerably, 4 = extremely. The clinician rates the 8 subjective items.
Nervous system disorders Feel like a spectator	38.9% 7/18 • Number of events 7 • 1 hour after infusion The Clinician-Administered Dissociative State Scale (CADSS) is a 27-item scale. The subjective component consists of 19 clinician administered items that are meant to depict the subjects state at the time that the items are being asked of them. The range of possible responses: 0 = not at all, 1 = slightly, 2= moderately, 3 = considerably, 4 = extremely. The clinician rates the 8 subjective items.	11.8% 2/17 • Number of events 2 • 1 hour after infusion The Clinician-Administered Dissociative State Scale (CADSS) is a 27-item scale. The subjective component consists of 19 clinician administered items that are meant to depict the subjects state at the time that the items are being asked of them. The range of possible responses: 0 = not at all, 1 = slightly, 2= moderately, 3 = considerably, 4 = extremely. The clinician rates the 8 subjective items.
Nervous system disorders Feel disconnected from your own body	27.8% 5/18 • Number of events 5 • 1 hour after infusion The Clinician-Administered Dissociative State Scale (CADSS) is a 27-item scale. The subjective component consists of 19 clinician administered items that are meant to depict the subjects state at the time that the items are being asked of them. The range of possible responses: 0 = not at all, 1 = slightly, 2= moderately, 3 = considerably, 4 = extremely. The clinician rates the 8 subjective items.	11.8% 2/17 • Number of events 2 • 1 hour after infusion The Clinician-Administered Dissociative State Scale (CADSS) is a 27-item scale. The subjective component consists of 19 clinician administered items that are meant to depict the subjects state at the time that the items are being asked of them. The range of possible responses: 0 = not at all, 1 = slightly, 2= moderately, 3 = considerably, 4 = extremely. The clinician rates the 8 subjective items.
Nervous system disorders Sense of your own body feel changed	22.2% 4/18 • Number of events 4 • 1 hour after infusion The Clinician-Administered Dissociative State Scale (CADSS) is a 27-item scale. The subjective component consists of 19 clinician administered items that are meant to depict the subjects state at the time that the items are being asked of them. The range of possible responses: 0 = not at all, 1 = slightly, 2= moderately, 3 = considerably, 4 = extremely. The clinician rates the 8 subjective items.	0.00% 0/17 • 1 hour after infusion The Clinician-Administered Dissociative State Scale (CADSS) is a 27-item scale. The subjective component consists of 19 clinician administered items that are meant to depict the subjects state at the time that the items are being asked of them. The range of possible responses: 0 = not at all, 1 = slightly, 2= moderately, 3 = considerably, 4 = extremely. The clinician rates the 8 subjective items.
Nervous system disorders Objects look different	16.7% 3/18 • Number of events 3 • 1 hour after infusion The Clinician-Administered Dissociative State Scale (CADSS) is a 27-item scale. The subjective component consists of 19 clinician administered items that are meant to depict the subjects state at the time that the items are being asked of them. The range of possible responses: 0 = not at all, 1 = slightly, 2= moderately, 3 = considerably, 4 = extremely. The clinician rates the 8 subjective items.	0.00% 0/17 • 1 hour after infusion The Clinician-Administered Dissociative State Scale (CADSS) is a 27-item scale. The subjective component consists of 19 clinician administered items that are meant to depict the subjects state at the time that the items are being asked of them. The range of possible responses: 0 = not at all, 1 = slightly, 2= moderately, 3 = considerably, 4 = extremely. The clinician rates the 8 subjective items.
Nervous system disorders Feel as if you were in a tunnel	27.8% 5/18 • Number of events 5 • 1 hour after infusion The Clinician-Administered Dissociative State Scale (CADSS) is a 27-item scale. The subjective component consists of 19 clinician administered items that are meant to depict the subjects state at the time that the items are being asked of them. The range of possible responses: 0 = not at all, 1 = slightly, 2= moderately, 3 = considerably, 4 = extremely. The clinician rates the 8 subjective items.	5.9% 1/17 • Number of events 1 • 1 hour after infusion The Clinician-Administered Dissociative State Scale (CADSS) is a 27-item scale. The subjective component consists of 19 clinician administered items that are meant to depict the subjects state at the time that the items are being asked of them. The range of possible responses: 0 = not at all, 1 = slightly, 2= moderately, 3 = considerably, 4 = extremely. The clinician rates the 8 subjective items.
Nervous system disorders Things happening very quickly	5.6% 1/18 • Number of events 1 • 1 hour after infusion The Clinician-Administered Dissociative State Scale (CADSS) is a 27-item scale. The subjective component consists of 19 clinician administered items that are meant to depict the subjects state at the time that the items are being asked of them. The range of possible responses: 0 = not at all, 1 = slightly, 2= moderately, 3 = considerably, 4 = extremely. The clinician rates the 8 subjective items.	5.9% 1/17 • Number of events 1 • 1 hour after infusion The Clinician-Administered Dissociative State Scale (CADSS) is a 27-item scale. The subjective component consists of 19 clinician administered items that are meant to depict the subjects state at the time that the items are being asked of them. The range of possible responses: 0 = not at all, 1 = slightly, 2= moderately, 3 = considerably, 4 = extremely. The clinician rates the 8 subjective items.
Nervous system disorders Things you can't account for	33.3% 6/18 • Number of events 6 • 1 hour after infusion The Clinician-Administered Dissociative State Scale (CADSS) is a 27-item scale. The subjective component consists of 19 clinician administered items that are meant to depict the subjects state at the time that the items are being asked of them. The range of possible responses: 0 = not at all, 1 = slightly, 2= moderately, 3 = considerably, 4 = extremely. The clinician rates the 8 subjective items.	5.9% 1/17 • Number of events 1 • 1 hour after infusion The Clinician-Administered Dissociative State Scale (CADSS) is a 27-item scale. The subjective component consists of 19 clinician administered items that are meant to depict the subjects state at the time that the items are being asked of them. The range of possible responses: 0 = not at all, 1 = slightly, 2= moderately, 3 = considerably, 4 = extremely. The clinician rates the 8 subjective items.
Nervous system disorders Spaced out	72.2% 13/18 • Number of events 13 • 1 hour after infusion The Clinician-Administered Dissociative State Scale (CADSS) is a 27-item scale. The subjective component consists of 19 clinician administered items that are meant to depict the subjects state at the time that the items are being asked of them. The range of possible responses: 0 = not at all, 1 = slightly, 2= moderately, 3 = considerably, 4 = extremely. The clinician rates the 8 subjective items.	23.5% 4/17 • Number of events 4 • 1 hour after infusion The Clinician-Administered Dissociative State Scale (CADSS) is a 27-item scale. The subjective component consists of 19 clinician administered items that are meant to depict the subjects state at the time that the items are being asked of them. The range of possible responses: 0 = not at all, 1 = slightly, 2= moderately, 3 = considerably, 4 = extremely. The clinician rates the 8 subjective items.
Nervous system disorders Sounds almost disappear	27.8% 5/18 • Number of events 5 • 1 hour after infusion The Clinician-Administered Dissociative State Scale (CADSS) is a 27-item scale. The subjective component consists of 19 clinician administered items that are meant to depict the subjects state at the time that the items are being asked of them. The range of possible responses: 0 = not at all, 1 = slightly, 2= moderately, 3 = considerably, 4 = extremely. The clinician rates the 8 subjective items.	5.9% 1/17 • Number of events 1 • 1 hour after infusion The Clinician-Administered Dissociative State Scale (CADSS) is a 27-item scale. The subjective component consists of 19 clinician administered items that are meant to depict the subjects state at the time that the items are being asked of them. The range of possible responses: 0 = not at all, 1 = slightly, 2= moderately, 3 = considerably, 4 = extremely. The clinician rates the 8 subjective items.
Nervous system disorders things seem to be very real	16.7% 3/18 • Number of events 3 • 1 hour after infusion The Clinician-Administered Dissociative State Scale (CADSS) is a 27-item scale. The subjective component consists of 19 clinician administered items that are meant to depict the subjects state at the time that the items are being asked of them. The range of possible responses: 0 = not at all, 1 = slightly, 2= moderately, 3 = considerably, 4 = extremely. The clinician rates the 8 subjective items.	0.00% 0/17 • 1 hour after infusion The Clinician-Administered Dissociative State Scale (CADSS) is a 27-item scale. The subjective component consists of 19 clinician administered items that are meant to depict the subjects state at the time that the items are being asked of them. The range of possible responses: 0 = not at all, 1 = slightly, 2= moderately, 3 = considerably, 4 = extremely. The clinician rates the 8 subjective items.
Nervous system disorders Outside of your body	22.2% 4/18 • Number of events 4 • 1 hour after infusion The Clinician-Administered Dissociative State Scale (CADSS) is a 27-item scale. The subjective component consists of 19 clinician administered items that are meant to depict the subjects state at the time that the items are being asked of them. The range of possible responses: 0 = not at all, 1 = slightly, 2= moderately, 3 = considerably, 4 = extremely. The clinician rates the 8 subjective items.	5.9% 1/17 • Number of events 1 • 1 hour after infusion The Clinician-Administered Dissociative State Scale (CADSS) is a 27-item scale. The subjective component consists of 19 clinician administered items that are meant to depict the subjects state at the time that the items are being asked of them. The range of possible responses: 0 = not at all, 1 = slightly, 2= moderately, 3 = considerably, 4 = extremely. The clinician rates the 8 subjective items.
Nervous system disorders Colors seem brighter	5.6% 1/18 • Number of events 1 • 1 hour after infusion The Clinician-Administered Dissociative State Scale (CADSS) is a 27-item scale. The subjective component consists of 19 clinician administered items that are meant to depict the subjects state at the time that the items are being asked of them. The range of possible responses: 0 = not at all, 1 = slightly, 2= moderately, 3 = considerably, 4 = extremely. The clinician rates the 8 subjective items.	5.9% 1/17 • Number of events 1 • 1 hour after infusion The Clinician-Administered Dissociative State Scale (CADSS) is a 27-item scale. The subjective component consists of 19 clinician administered items that are meant to depict the subjects state at the time that the items are being asked of them. The range of possible responses: 0 = not at all, 1 = slightly, 2= moderately, 3 = considerably, 4 = extremely. The clinician rates the 8 subjective items.
Nervous system disorders Confused about who you really are	11.1% 2/18 • Number of events 2 • 1 hour after infusion The Clinician-Administered Dissociative State Scale (CADSS) is a 27-item scale. The subjective component consists of 19 clinician administered items that are meant to depict the subjects state at the time that the items are being asked of them. The range of possible responses: 0 = not at all, 1 = slightly, 2= moderately, 3 = considerably, 4 = extremely. The clinician rates the 8 subjective items.	0.00% 0/17 • 1 hour after infusion The Clinician-Administered Dissociative State Scale (CADSS) is a 27-item scale. The subjective component consists of 19 clinician administered items that are meant to depict the subjects state at the time that the items are being asked of them. The range of possible responses: 0 = not at all, 1 = slightly, 2= moderately, 3 = considerably, 4 = extremely. The clinician rates the 8 subjective items.
Nervous system disorders Parts of your body that don't fit together	5.6% 1/18 • Number of events 1 • 1 hour after infusion The Clinician-Administered Dissociative State Scale (CADSS) is a 27-item scale. The subjective component consists of 19 clinician administered items that are meant to depict the subjects state at the time that the items are being asked of them. The range of possible responses: 0 = not at all, 1 = slightly, 2= moderately, 3 = considerably, 4 = extremely. The clinician rates the 8 subjective items.	0.00% 0/17 • 1 hour after infusion The Clinician-Administered Dissociative State Scale (CADSS) is a 27-item scale. The subjective component consists of 19 clinician administered items that are meant to depict the subjects state at the time that the items are being asked of them. The range of possible responses: 0 = not at all, 1 = slightly, 2= moderately, 3 = considerably, 4 = extremely. The clinician rates the 8 subjective items.
Nervous system disorders gaps in your memory	44.4% 8/18 • Number of events 8 • 1 hour after infusion The Clinician-Administered Dissociative State Scale (CADSS) is a 27-item scale. The subjective component consists of 19 clinician administered items that are meant to depict the subjects state at the time that the items are being asked of them. The range of possible responses: 0 = not at all, 1 = slightly, 2= moderately, 3 = considerably, 4 = extremely. The clinician rates the 8 subjective items.	0.00% 0/17 • 1 hour after infusion The Clinician-Administered Dissociative State Scale (CADSS) is a 27-item scale. The subjective component consists of 19 clinician administered items that are meant to depict the subjects state at the time that the items are being asked of them. The range of possible responses: 0 = not at all, 1 = slightly, 2= moderately, 3 = considerably, 4 = extremely. The clinician rates the 8 subjective items.
Nervous system disorders having more than one identity	5.6% 1/18 • Number of events 1 • 1 hour after infusion The Clinician-Administered Dissociative State Scale (CADSS) is a 27-item scale. The subjective component consists of 19 clinician administered items that are meant to depict the subjects state at the time that the items are being asked of them. The range of possible responses: 0 = not at all, 1 = slightly, 2= moderately, 3 = considerably, 4 = extremely. The clinician rates the 8 subjective items.	0.00% 0/17 • 1 hour after infusion The Clinician-Administered Dissociative State Scale (CADSS) is a 27-item scale. The subjective component consists of 19 clinician administered items that are meant to depict the subjects state at the time that the items are being asked of them. The range of possible responses: 0 = not at all, 1 = slightly, 2= moderately, 3 = considerably, 4 = extremely. The clinician rates the 8 subjective items.
Cardiac disorders Tachycardia	22.2% 4/18 • Number of events 4 • 1 hour after infusion The Clinician-Administered Dissociative State Scale (CADSS) is a 27-item scale. The subjective component consists of 19 clinician administered items that are meant to depict the subjects state at the time that the items are being asked of them. The range of possible responses: 0 = not at all, 1 = slightly, 2= moderately, 3 = considerably, 4 = extremely. The clinician rates the 8 subjective items.	0.00% 0/17 • 1 hour after infusion The Clinician-Administered Dissociative State Scale (CADSS) is a 27-item scale. The subjective component consists of 19 clinician administered items that are meant to depict the subjects state at the time that the items are being asked of them. The range of possible responses: 0 = not at all, 1 = slightly, 2= moderately, 3 = considerably, 4 = extremely. The clinician rates the 8 subjective items.
Cardiac disorders diastolyc hypertension	16.7% 3/18 • Number of events 3 • 1 hour after infusion The Clinician-Administered Dissociative State Scale (CADSS) is a 27-item scale. The subjective component consists of 19 clinician administered items that are meant to depict the subjects state at the time that the items are being asked of them. The range of possible responses: 0 = not at all, 1 = slightly, 2= moderately, 3 = considerably, 4 = extremely. The clinician rates the 8 subjective items.	0.00% 0/17 • 1 hour after infusion The Clinician-Administered Dissociative State Scale (CADSS) is a 27-item scale. The subjective component consists of 19 clinician administered items that are meant to depict the subjects state at the time that the items are being asked of them. The range of possible responses: 0 = not at all, 1 = slightly, 2= moderately, 3 = considerably, 4 = extremely. The clinician rates the 8 subjective items.
Gastrointestinal disorders Nausea	16.7% 3/18 • Number of events 3 • 1 hour after infusion The Clinician-Administered Dissociative State Scale (CADSS) is a 27-item scale. The subjective component consists of 19 clinician administered items that are meant to depict the subjects state at the time that the items are being asked of them. The range of possible responses: 0 = not at all, 1 = slightly, 2= moderately, 3 = considerably, 4 = extremely. The clinician rates the 8 subjective items.	0.00% 0/17 • 1 hour after infusion The Clinician-Administered Dissociative State Scale (CADSS) is a 27-item scale. The subjective component consists of 19 clinician administered items that are meant to depict the subjects state at the time that the items are being asked of them. The range of possible responses: 0 = not at all, 1 = slightly, 2= moderately, 3 = considerably, 4 = extremely. The clinician rates the 8 subjective items.
Cardiac disorders systolic hypertension	11.1% 2/18 • Number of events 2 • 1 hour after infusion The Clinician-Administered Dissociative State Scale (CADSS) is a 27-item scale. The subjective component consists of 19 clinician administered items that are meant to depict the subjects state at the time that the items are being asked of them. The range of possible responses: 0 = not at all, 1 = slightly, 2= moderately, 3 = considerably, 4 = extremely. The clinician rates the 8 subjective items.	0.00% 0/17 • 1 hour after infusion The Clinician-Administered Dissociative State Scale (CADSS) is a 27-item scale. The subjective component consists of 19 clinician administered items that are meant to depict the subjects state at the time that the items are being asked of them. The range of possible responses: 0 = not at all, 1 = slightly, 2= moderately, 3 = considerably, 4 = extremely. The clinician rates the 8 subjective items.
Cardiac disorders diastolyc hypotension	11.1% 2/18 • Number of events 2 • 1 hour after infusion The Clinician-Administered Dissociative State Scale (CADSS) is a 27-item scale. The subjective component consists of 19 clinician administered items that are meant to depict the subjects state at the time that the items are being asked of them. The range of possible responses: 0 = not at all, 1 = slightly, 2= moderately, 3 = considerably, 4 = extremely. The clinician rates the 8 subjective items.	0.00% 0/17 • 1 hour after infusion The Clinician-Administered Dissociative State Scale (CADSS) is a 27-item scale. The subjective component consists of 19 clinician administered items that are meant to depict the subjects state at the time that the items are being asked of them. The range of possible responses: 0 = not at all, 1 = slightly, 2= moderately, 3 = considerably, 4 = extremely. The clinician rates the 8 subjective items.
Nervous system disorders parestesias and numbness	50.0% 9/18 • Number of events 9 • 1 hour after infusion The Clinician-Administered Dissociative State Scale (CADSS) is a 27-item scale. The subjective component consists of 19 clinician administered items that are meant to depict the subjects state at the time that the items are being asked of them. The range of possible responses: 0 = not at all, 1 = slightly, 2= moderately, 3 = considerably, 4 = extremely. The clinician rates the 8 subjective items.	0.00% 0/17 • 1 hour after infusion The Clinician-Administered Dissociative State Scale (CADSS) is a 27-item scale. The subjective component consists of 19 clinician administered items that are meant to depict the subjects state at the time that the items are being asked of them. The range of possible responses: 0 = not at all, 1 = slightly, 2= moderately, 3 = considerably, 4 = extremely. The clinician rates the 8 subjective items.
Nervous system disorders dizziness	33.3% 6/18 • Number of events 6 • 1 hour after infusion The Clinician-Administered Dissociative State Scale (CADSS) is a 27-item scale. The subjective component consists of 19 clinician administered items that are meant to depict the subjects state at the time that the items are being asked of them. The range of possible responses: 0 = not at all, 1 = slightly, 2= moderately, 3 = considerably, 4 = extremely. The clinician rates the 8 subjective items.	0.00% 0/17 • 1 hour after infusion The Clinician-Administered Dissociative State Scale (CADSS) is a 27-item scale. The subjective component consists of 19 clinician administered items that are meant to depict the subjects state at the time that the items are being asked of them. The range of possible responses: 0 = not at all, 1 = slightly, 2= moderately, 3 = considerably, 4 = extremely. The clinician rates the 8 subjective items.