Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Ketamine as a Rapid Treatment for Post-traumatic Stress Disorder (PTSD) (KetPTSD)

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: NCT00749203
Recruitment Status : Completed
First Posted : September 9, 2008
Results First Posted : February 14, 2018
Last Update Posted : February 14, 2018
Sponsor:
Collaborator:
United States Department of Defense
Information provided by (Responsible Party):
Dennis Charney, Icahn School of Medicine at Mount Sinai

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Stress Disorders, Post-Traumatic
PTSD
Depression
Anxiety Disorder
Interventions Drug: Midazolam
Drug: Ketamine
Enrollment 41
Recruitment Details Patients with chronic PTSD related to a range of trauma exposures were recruited via advertisements beginning Jan 2009, and were enrolled at the Icahn School of Medicine at Mount Sinai, New York, between May 2009 and December 2012.
Pre-assignment Details  
Arm/Group Title Ketamine Then Midazolam Midazolam Then Ketamine
Hide Arm/Group Description

Ketamine: Single dose 0.5 mg/kg IV (in the vein) infused over 40 minutes on day 1,

then 2 weeks later, Midazolam: single dose 0.045 mg/kg IV infused over 40 minutes

Midazolam: single dose 0.045 mg/kg IV infused over 40 minutes on day 1, then 2 weeks later, Ketamine: Single dose 0.5 mg/kg IV (in the vein) infused over 40 minutes
Period Title: First Infusion Day 1
Started 22 19
Completed 22 19
Not Completed 0 0
Period Title: no Infusion at Week 1
Started 22 19
Completed 22 15
Not Completed 0 4
Reason Not Completed
Lost to Follow-up             0             1
Withdrawal by Subject             0             1
delayed-onset sedation             0             1
low baseline PTSD symptoms level             0             1
Period Title: Second Infusion at 2 Weeks
Started 16 [1] 15
Completed 16 13
Not Completed 0 2
Reason Not Completed
Protocol Violation             0             1
pt felt uncomfortable after infusion             0             1
[1]
N=6 completed the study at 2 wks due to CAPS scores < 50, precluding 2nd infusion.
Arm/Group Title Ketamine Then Midazolam Midazolam the Ketamine Total
Hide Arm/Group Description Ketamine: Single dose 0.5 mg/kg IV (in the vein) infused over 40 minutes on Day 1, then 2 weeks later, Midazolam: single dose 0.045 mg/kg IV infused over 40 minutes Midazolam: single dose 0.045 mg/kg IV infused over 40 minutes on Day 1, then 2 weeks later Ketamine: Single dose 0.5 mg/kg IV (in the vein) infused over 40 minutes Total of all reporting groups
Overall Number of Baseline Participants 22 19 41
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 22 participants 19 participants 41 participants
36.4  (10.8) 35.7  (10.0) 36.05  (10.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 19 participants 41 participants
Female
13
  59.1%
6
  31.6%
19
  46.3%
Male
9
  40.9%
13
  68.4%
22
  53.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 19 participants 41 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
11
  50.0%
12
  63.2%
23
  56.1%
White
5
  22.7%
2
  10.5%
7
  17.1%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
6
  27.3%
5
  26.3%
11
  26.8%
Education  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 22 participants 19 participants 41 participants
less than high school 1 0 1
high school graduate 3 3 6
some college 12 14 26
more than 4 years of college 5 2 7
unknown 1 0 1
Percentage Unemployed  
Measure Type: Number
Unit of measure:  Percentage of participants
Number Analyzed 22 participants 19 participants 41 participants
50 73.7 123.7
Primary Trauma  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 22 participants 19 participants 41 participants
Sexual assault or molestation 9 0 9
Physical assault or abuse 4 7 11
Accident or fire 1 3 4
Combat exposure 2 0 2
Witnessed violent assault or death 4 5 9
Witnessed 9/11 terrorist attacks 2 0 2
Unknown 0 4 4
Duration of PTSD  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 22 participants 19 participants 41 participants
14.2  (12.3) 11.9  (14.0) 13.1  (13.1)
History of treatment with psychotropic medication  
Measure Type: Number
Unit of measure:  Percentage of participants
Number Analyzed 22 participants 19 participants 41 participants
50 42.1 92.1
Clinician-Administered PTSD Scale (CAPS) score (past month)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 22 participants 19 participants 41 participants
82.5  (14.1) 77.1  (11.8) 80.0  (13.0)
[1]
Measure Description:

frequency score - scale 0 = none of the time to 4 = most or all of the time intensity score - scale 0 = none to 4 = extreme To meet criteria for a symptom, a patient must meet criteria in both frequency and intensity score for each item. Frequency and intensity and then combined to form a single severity score.

30 questions scale, with total score ranging from 0 to 240.

Quick Inventory of Depressive Symptomatology, Self-Report (QIDS-SR) score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 22 participants 19 participants 41 participants
12.4  (5.2) 11.3  (5.6) 11.9  (5.4)
[1]
Measure Description: Each item is rated 0 (no depression) to 3 (severe depression). The total score ranges from 0-27.
1.Primary Outcome
Title Impact of Event Scale - Revised (IES-R)
Hide Description A 22-item self-report questionnaire measuring PTSD symptoms. Items are rated on a 5-point scale ranging from 0 ("not at all") to 4 ("extremely"). The IES-R yields a total score ranging from 0 (not at all) to 88 (extremely)
Time Frame 7 days after first infusion
Hide Outcome Measure Data
Hide Analysis Population Description
Not all participants returned for the 1 week follow up visit. There were 19 participants from the Ketamine group and 15 participants from the Midazolam group who returned for their followup visit and completed the IES-R at the 1 week follow up visit.
Arm/Group Title Ketamine Midazolam
Hide Arm/Group Description:

Single dose 0.5 mg/kg IV (in the vein) infused over 40 minutes

Ketamine: Single dose 0.5 mg/kg IV (in the vein) infused over 40 minutes

single dose 0.045 mg/kg IV infused over 40 minutes

Midazolam: single dose 0.045 mg/kg IV infused over 40 minutes

Overall Number of Participants Analyzed 19 15
Mean (Standard Deviation)
Unit of Measure: units on a scale
25.76  (19.4) 36.32  (13.73)
2.Secondary Outcome
Title Clinician-Administered PTSD Scale (CAPS)
Hide Description Clinician-administered structured interview measuring PTSD symptoms. frequency score - scale 0 = none of the time to 4 = most or all of the time intensity score - scale 0 = none to 4 = extreme To meet criteria for a symptom, a patient must meet criteria in both frequency and intensity score for each item. Frequency and intensity and then combined to form a single severity score. 30 questions scale, with total score ranging from 0 to 240.
Time Frame 7 days after first infusion
Hide Outcome Measure Data
Hide Analysis Population Description
Not all participants returned for the 1 week follow up visit. There were 19 participants from the Ketamine group and 15 participants from the Midazolam group who returned for their followup visit and completed the IES-R at the 1 week follow up visit.
Arm/Group Title Ketamine Midazolam
Hide Arm/Group Description:

Single dose 0.5 mg/kg IV (in the vein) infused over 40 minutes

Ketamine: Single dose 0.5 mg/kg IV (in the vein) infused over 40 minutes

single dose 0.045 mg/kg IV infused over 40 minutes

Midazolam: single dose 0.045 mg/kg IV infused over 40 minutes

Overall Number of Participants Analyzed 19 15
Mean (Standard Deviation)
Unit of Measure: units on a scale
54  (23.63) 65.69  (16.36)
3.Secondary Outcome
Title Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR)
Hide Description Self-report questionnaire measuring depressive symptoms. Each item is rated 0 (no depression) to 3 (severe depression). The total score ranges from 0-27.
Time Frame 24 hours after first infusion
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ketamine Midazolam
Hide Arm/Group Description:

Single dose 0.5 mg/kg IV (in the vein) infused over 40 minutes

Ketamine: Single dose 0.5 mg/kg IV (in the vein) infused over 40 minutes

single dose 0.045 mg/kg IV infused over 40 minutes

Midazolam: single dose 0.045 mg/kg IV infused over 40 minutes

Overall Number of Participants Analyzed 22 19
Mean (Standard Deviation)
Unit of Measure: units on a scale
12.4  (5.2) 11.3  (5.6)
4.Secondary Outcome
Title Montgomery-Asberg Depression Rating Scale (MADRS)
Hide Description Clinician-administered questionnaire measuring depressive symptoms. The MADRS-S has 10-items which are based on mood symptoms over the past 7 days. Each items is scored 0 (normal) to 6 (severe depression) with overall score ranges from 0 (normal) to 60 (severe depression). Mean difference between baseline and 2 weeks.
Time Frame 24 hours after first infusion
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ketamine Midazolam
Hide Arm/Group Description:

Single dose 0.5 mg/kg IV (in the vein) infused over 40 minutes

Ketamine: Single dose 0.5 mg/kg IV (in the vein) infused over 40 minutes

single dose 0.045 mg/kg IV infused over 40 minutes

Midazolam: single dose 0.045 mg/kg IV infused over 40 minutes

Overall Number of Participants Analyzed 22 19
Mean (Standard Deviation)
Unit of Measure: units on a scale
12.6  (7.9) 10.1  (9.7)
5.Secondary Outcome
Title Hopkins Verbal Learning Test (HVLT)
Hide Description Repeatable test of memory acquisition and delayed recall of words. It is a three-trial list learning and free recall task comprising 12 words, 4 words from each of three semantic categories. Total Recall score range is 0 to 36.
Time Frame 20 to 40 minutes after infusion
Hide Outcome Measure Data
Hide Analysis Population Description
data not collected
Arm/Group Title Ketamine Midazolam
Hide Arm/Group Description:

Single dose 0.5 mg/kg IV (in the vein) infused over 40 minutes

Ketamine: Single dose 0.5 mg/kg IV (in the vein) infused over 40 minutes

single dose 0.045 mg/kg IV infused over 40 minutes

Midazolam: single dose 0.045 mg/kg IV infused over 40 minutes

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame 24 hours post infusion
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ketamine Midazolam
Hide Arm/Group Description Ketamine: Single dose 0.5 mg/kg IV (in the vein) infused over 40 minutes, Midazolam: single dose 0.045 mg/kg IV infused over 40 minutes
All-Cause Mortality
Ketamine Midazolam
Affected / at Risk (%) Affected / at Risk (%)
Total   0/38 (0.00%)   0/31 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Ketamine Midazolam
Affected / at Risk (%) Affected / at Risk (%)
Total   33/38 (86.84%)   31/31 (100.00%) 
Cardiac disorders     
Palpitation  1  3/38 (7.89%)  0/31 (0.00%) 
Dizziness on standing  1  6/38 (15.79%)  5/31 (16.13%) 
Chest Pain  1  2/38 (5.26%)  3/31 (9.68%) 
Ear and labyrinth disorders     
Ringing in ears  1  5/38 (13.16%)  1/31 (3.23%) 
Eye disorders     
Blurred vision  1  15/38 (39.47%)  6/31 (19.35%) 
Gastrointestinal disorders     
Diarrhea  1  3/38 (7.89%)  2/31 (6.45%) 
Dry Mouth  1  10/38 (26.32%)  4/31 (12.90%) 
Nausea/Vomiting  1  10/38 (26.32%)  0/31 (0.00%) 
General disorders     
Difficulty sleeping  1  3/38 (7.89%)  3/31 (9.68%) 
Sleeping too much  1  2/38 (5.26%)  1/31 (3.23%) 
Anxiety  1  5/38 (13.16%)  1/31 (3.23%) 
Poor concentration  1  4/38 (10.53%)  6/31 (19.35%) 
General malaise  1  3/38 (7.89%)  1/31 (3.23%) 
Restlessness  1  13/38 (34.21%)  4/31 (12.90%) 
Fatigue  1  10/38 (26.32%)  6/31 (19.35%) 
Decreased energy  1  6/38 (15.79%)  3/31 (9.68%) 
Nervous system disorders     
Headace  1  8/38 (21.05%)  4/31 (12.90%) 
Tremors  1  0/38 (0.00%)  1/31 (3.23%) 
Poor coordination  1  7/38 (18.42%)  1/31 (3.23%) 
Dizziness  1  14/38 (36.84%)  9/31 (29.03%) 
Renal and urinary disorders     
Difficulty urinating  1  0/38 (0.00%)  3/31 (9.68%) 
Painful urination  1  2/38 (5.26%)  1/31 (3.23%) 
Frequent urination  1  2/38 (5.26%)  4/31 (12.90%) 
Skin and subcutaneous tissue disorders     
Rash  1  1/38 (2.63%)  0/31 (0.00%) 
Increased perspiration  1  3/38 (7.89%)  1/31 (3.23%) 
Itching  1  1/38 (2.63%)  0/31 (0.00%) 
Dry skin  1  2/38 (5.26%)  1/31 (3.23%) 
1
Term from vocabulary, PRISE
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Ketamine Midazolam
Affected / at Risk (%) Affected / at Risk (%)
Total   0/38 (0.00%)   0/31 (0.00%) 
Several patients did not receive a second infusion per protocol because of sustained reduction in PTSD symptom levels . The study also does not address the safety or efficacy of ketamine in combination with other psychotropic medications in PTSD.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Adriana Feder
Organization: Icahn School of Medicine at Mount Sinai
Phone: 212-241-1563
Responsible Party: Dennis Charney, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT00749203     History of Changes
Other Study ID Numbers: GCO 07-1199
PT074949
IF1554104
A-15236 ( Other Identifier: USAMRMC ORP HRPO )
First Submitted: September 5, 2008
First Posted: September 9, 2008
Results First Submitted: April 12, 2017
Results First Posted: February 14, 2018
Last Update Posted: February 14, 2018