Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Ketamine Infusion for Social Anxiety Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02083926
Recruitment Status : Completed
First Posted : March 11, 2014
Results First Posted : March 18, 2021
Last Update Posted : March 18, 2021
Sponsor:
Collaborator:
Patterson Trust Awards Program in Clinical Research
Information provided by (Responsible Party):
Yale University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Social Anxiety Disorder
Interventions Drug: Ketamine
Other: Saline
Enrollment 18
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Ketamine Infusion on Day 0, Saline Infusion on Day 28 Saline Infusion on Day 0, Ketamine Infusion on Day 28
Hide Arm/Group Description 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. 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.
Period Title: Overall Study
Started 9 9
Completed 8 9
Not Completed 1 0
Reason Not Completed
Withdrawal by Subject             1             0
Arm/Group Title Ketamine Infusion on Day 0, Saline Infusion on Day 28 Saline Infusion on Day 0, Ketamine Infusion on Day 28 Total
Hide Arm/Group Description 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. 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 of all reporting groups
Overall Number of Baseline Participants 9 9 18
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 9 participants 18 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
9
 100.0%
9
 100.0%
18
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 9 participants 9 participants 18 participants
30.78  (13.50) 28.67  (8.66) 29.72  (11.05)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 9 participants 18 participants
Female
2
  22.2%
5
  55.6%
7
  38.9%
Male
7
  77.8%
4
  44.4%
11
  61.1%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 9 participants 18 participants
Non-Hispanic White
8
  88.9%
6
  66.7%
14
  77.8%
Non-Hispanic Asian
0
   0.0%
2
  22.2%
2
  11.1%
Hispanic
1
  11.1%
1
  11.1%
2
  11.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 9 participants 9 participants 18 participants
9 9 18
Visual Analogue Scale for anxiety symptoms (VAS-anxiety)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 9 participants 9 participants 18 participants
47.22  (18.89) 57.78  (19.70) 47.22  (18.89)
[1]
Measure Description: 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.
Liebowitz Social Anxiety Score (LSAS)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 9 participants 9 participants 18 participants
93.89  (19.37) 87.44  (14.53) 90.67  (16.94)
[1]
Measure Description: 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
1.Primary Outcome
Title Visual Analogue Scale for Anxiety Symptoms (VAS-anxiety)
Hide Description

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.

Time Frame Day 1 (1+28)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ketamine Infusion on Day 0 or Day 28 Saline Infusion on Day 0 or Day 28
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 18 17
Mean (Standard Deviation)
Unit of Measure: units on a scale
12.1  (18.6) 19.6  (18.5)
2.Primary Outcome
Title Liebowitz Social Anxiety Score (LSAS)
Hide Description 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
Time Frame Day 1 (1+28)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ketamine Infusion on Day 0 or Day 28 Saline Infusion on Day 0 or Day 28
Hide Arm/Group Description:
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.
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, 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.
Overall Number of Participants Analyzed 18 17
Mean (Standard Deviation)
Unit of Measure: score on a scale
66.1  (30.9) 86.1  (30)
Time Frame 1 hour after infusion
Adverse Event Reporting Description 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.
 
Arm/Group Title Ketamine Infusion on Day 0 or Day 28 Saline Infusion on Day 0 or Day 28
Hide Arm/Group Description 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. 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.
All-Cause Mortality
Ketamine Infusion on Day 0 or Day 28 Saline Infusion on Day 0 or Day 28
Affected / at Risk (%) Affected / at Risk (%)
Total   0/18 (0.00%)      0/17 (0.00%)    
Hide Serious Adverse Events
Ketamine Infusion on Day 0 or Day 28 Saline Infusion on Day 0 or Day 28
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/18 (0.00%)      0/17 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Ketamine Infusion on Day 0 or Day 28 Saline Infusion on Day 0 or Day 28
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   15/18 (83.33%)      4/17 (23.53%)    
Cardiac disorders     
Tachycardia  1 [1]  4/18 (22.22%)  4 0/17 (0.00%)  0
diastolyc hypertension  1 [2]  3/18 (16.67%)  3 0/17 (0.00%)  0
systolic hypertension  1 [3]  2/18 (11.11%)  2 0/17 (0.00%)  0
diastolyc hypotension  1 [4]  2/18 (11.11%)  2 0/17 (0.00%)  0
Gastrointestinal disorders     
Nausea  1  3/18 (16.67%)  3 0/17 (0.00%)  0
Nervous system disorders     
things seem to be moving  1  7/18 (38.89%)  7 2/17 (11.76%)  2
things seem unreal  1  9/18 (50.00%)  9 3/17 (17.65%)  3
feel like you are separated from reality  1  3/18 (16.67%)  3 1/17 (5.88%)  1
looking at things outside of your body  1  4/18 (22.22%)  4 0/17 (0.00%)  0
Feel like a spectator  1  7/18 (38.89%)  7 2/17 (11.76%)  2
Feel disconnected from your own body  1  5/18 (27.78%)  5 2/17 (11.76%)  2
Sense of your own body feel changed  1  4/18 (22.22%)  4 0/17 (0.00%)  0
Objects look different  1  3/18 (16.67%)  3 0/17 (0.00%)  0
Feel as if you were in a tunnel  1  5/18 (27.78%)  5 1/17 (5.88%)  1
Things happening very quickly  1  1/18 (5.56%)  1 1/17 (5.88%)  1
Things you can't account for  1  6/18 (33.33%)  6 1/17 (5.88%)  1
Spaced out  1  13/18 (72.22%)  13 4/17 (23.53%)  4
Sounds almost disappear  1  5/18 (27.78%)  5 1/17 (5.88%)  1
things seem to be very real  1  3/18 (16.67%)  3 0/17 (0.00%)  0
Outside of your body  1  4/18 (22.22%)  4 1/17 (5.88%)  1
Colors seem brighter  1  1/18 (5.56%)  1 1/17 (5.88%)  1
Confused about who you really are  1  2/18 (11.11%)  2 0/17 (0.00%)  0
Parts of your body that don't fit together  1  1/18 (5.56%)  1 0/17 (0.00%)  0
gaps in your memory  1  8/18 (44.44%)  8 0/17 (0.00%)  0
having more than one identity  1  1/18 (5.56%)  1 0/17 (0.00%)  0
parestesias and numbness  1  9/18 (50.00%)  9 0/17 (0.00%)  0
dizziness  1  6/18 (33.33%)  6 0/17 (0.00%)  0
1
Term from vocabulary, CADSS
Indicates events were collected by systematic assessment
[1]
>100 beats per minute
[2]
>90 mm Hg (max of 106mm Hg)
[3]
>160 mm Hg (max of 184mm Hg)
[4]
<60 mm Hg (min 49 mm Hg)
A significant limitation of our study was that 17 of 18 subjects correctly identified when they received ketamine, suggesting that the use of saline as a placebo control for ketamine led to inadequate blinding.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Michael H. Bloch
Organization: Yale University
Phone: 2037374539
EMail: michael.bloch@yale.edu
Layout table for additonal information
Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT02083926    
Other Study ID Numbers: 1310012947
First Submitted: March 5, 2014
First Posted: March 11, 2014
Results First Submitted: March 5, 2020
Results First Posted: March 18, 2021
Last Update Posted: March 18, 2021