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Ketamine as a Treatment for Post-Traumatic Stress Disorder (PTSD)

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ClinicalTrials.gov Identifier: NCT02397889
Recruitment Status : Completed
First Posted : March 25, 2015
Results First Posted : February 11, 2021
Last Update Posted : March 11, 2021
Sponsor:
Information provided by (Responsible Party):
Adriana Feder, Icahn School of Medicine at Mount Sinai

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Posttraumatic Stress Disorder (PTSD)
Interventions Drug: Ketamine
Drug: Midazolam
Enrollment 30
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Experimental Ketamine Group Active Control Midazolam Group
Hide Arm/Group Description 0.5mg/kg repeated dose ketamine (6 infusions, 3 per week for 2 weeks). 0.045mg/kg repeated dose midazolam (6 infusions, 3 per week for 2 weeks).
Period Title: Overall Study
Started 15 15
Completed 14 15
Not Completed 1 0
Reason Not Completed
Physician Decision             1             0
Arm/Group Title Experimental Ketamine Group Active Control Midazolam Group Total
Hide Arm/Group Description 0.5mg/kg repeated dose ketamine (6 infusions, 3 per week for 2 weeks). 0.045mg/kg repeated dose midazolam (6 infusions, 3 per week for 2 weeks). Total of all reporting groups
Overall Number of Baseline Participants 15 15 30
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 15 participants 15 participants 30 participants
39.3  (13.8) 38.5  (13.0) 38.9  (13.2)
Sex/Gender, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
 Number Analyzed 15 participants 15 participants 30 participants
Females
13
  86.7%
10
  66.7%
23
  76.7%
Males
1
   6.7%
5
  33.3%
6
  20.0%
Other
1
   6.7%
0
   0.0%
1
   3.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 15 participants 30 participants
Hispanic or Latino
3
  20.0%
3
  20.0%
6
  20.0%
Not Hispanic or Latino
11
  73.3%
11
  73.3%
22
  73.3%
Unknown or Not Reported
1
   6.7%
1
   6.7%
2
   6.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 15 participants 30 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
2
  13.3%
3
  20.0%
5
  16.7%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
2
  13.3%
3
  20.0%
5
  16.7%
White
9
  60.0%
7
  46.7%
16
  53.3%
More than one race
2
  13.3%
1
   6.7%
3
  10.0%
Unknown or Not Reported
0
   0.0%
1
   6.7%
1
   3.3%
Current treatment with psychotropic medication   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 15 participants 30 participants
7
  46.7%
6
  40.0%
13
  43.3%
[1]
Measure Description: Number of participants on current treatment with psychotropic medication
Clinician Administered PTSD Scale (CAPS-5) score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 15 participants 15 participants 30 participants
41.9  (6.1) 40.1  (5.9) 40.9  (5.9)
[1]
Measure Description: Clinician Administered PTSD Scale (CAPS-5) score, past month - full range score from 0-80, with higher scores indicating greater PTSD symptoms
The Impact of Events Scale - Revised (IES-R)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 15 participants 15 participants 30 participants
41.4  (14.0) 48.3  (20.1) 44.8  (17.3)
[1]
Measure Description: The Impact of Events Scale - Revised (IES-R) past 24 hours - full range score from 0-88, with higher scores indicating greater PTSD symptoms
Montgomery Asberg Depression Rating Scale (MADRS) score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 15 participants 15 participants 30 participants
27.9  (6.8) 26.9  (7.7) 27.4  (7.2)
[1]
Measure Description: Montgomery Asberg Depression Rating Scale (MADRS) score, past week - full range score from 0-60, with higher scores indicating greater depressive symptoms
Montgomery Asberg Depression Rating Scale (MADRS) score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 15 participants 15 participants 30 participants
26.4  (6.6) 25.3  (9.0) 25.8  (7.8)
[1]
Measure Description: Montgomery Asberg Depression Rating Scale (MADRS) score, past 24 hours
Duration of PTSD  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 15 participants 15 participants 30 participants
15.1  (17.8) 14.6  (7.8) 14.9  (13.5)
1.Primary Outcome
Title Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
Hide Description full range score from 0-80, with higher scores indicating greater PTSD symptoms
Time Frame 2 weeks after the first infusion
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Experimental Ketamine Group Active Control Midazolam Group
Hide Arm/Group Description:
0.5mg/kg repeated dose ketamine (6 infusions, 3 per week for 2 weeks).
0.045mg/kg repeated dose midazolam (6 infusions, 3 per week for 2 weeks).
Overall Number of Participants Analyzed 15 15
Mean (Standard Deviation)
Unit of Measure: score on a scale
22.5  (14.4) 33.2  (11.8)
2.Secondary Outcome
Title The Impact of Event Scale - Revised (IES-R)
Hide Description full range score from 0-88, with higher scores indicating greater PTSD symptoms
Time Frame 24 hours after the first drug infusion
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Experimental Ketamine Group Active Control Midazolam Group
Hide Arm/Group Description:
0.5mg/kg repeated dose ketamine (6 infusions, 3 per week for 2 weeks).
0.045mg/kg repeated dose midazolam (6 infusions, 3 per week for 2 weeks).
Overall Number of Participants Analyzed 15 15
Mean (Standard Deviation)
Unit of Measure: score on a scale
19.7  (15.2) 24.8  (13.1)
3.Secondary Outcome
Title Montgomery Asberg Depression Rating Scale (MADRS)
Hide Description full range score from 0-60, with higher scores indicating greater depressive symptoms
Time Frame 24 hours after the first drug infusion
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Experimental Ketamine Group Active Control Midazolam Group
Hide Arm/Group Description:
0.5mg/kg repeated dose ketamine (6 infusions, 3 per week for 2 weeks).
0.045mg/kg repeated dose midazolam (6 infusions, 3 per week for 2 weeks).
Overall Number of Participants Analyzed 15 15
Mean (Standard Deviation)
Unit of Measure: score on a scale
16.5  (9.6) 17.1  (9.4)
4.Secondary Outcome
Title Montgomery Asberg Depression Rating Scale (MADRS)
Hide Description full range score from 0-60, with higher scores indicating greater depressive symptoms
Time Frame 2 weeks after the first drug infusion
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Experimental Ketamine Group Active Control Midazolam Group
Hide Arm/Group Description:
0.5mg/kg repeated dose ketamine (6 infusions, 3 per week for 2 weeks).
0.045mg/kg repeated dose midazolam (6 infusions, 3 per week for 2 weeks).
Overall Number of Participants Analyzed 15 15
Mean (Standard Deviation)
Unit of Measure: score on a scale
14.7  (12.1) 21.9  (8.5)
5.Secondary Outcome
Title Quick Inventory of Depression Symptomatology - Self-Report (QIDS-SR)
Hide Description full range score from 0-27, with higher scores indicating greater depressive symptoms
Time Frame 2 weeks after the first drug infusion
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Experimental Ketamine Group Active Control Midazolam Group
Hide Arm/Group Description:
0.5mg/kg repeated dose ketamine (6 infusions, 3 per week for 2 weeks).
0.045mg/kg repeated dose midazolam (6 infusions, 3 per week for 2 weeks).
Overall Number of Participants Analyzed 15 15
Mean (Standard Deviation)
Unit of Measure: score on a scale
6.6  (7.1) 6.7  (5.4)
6.Secondary Outcome
Title Number of Participants With Patient-Rated Inventory of Side Effects (PRISE)
Hide Description All side effects listed in Adverse Event section.
Time Frame up to 21 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Experimental Ketamine Group Active Control Midazolam Group
Hide Arm/Group Description:
0.5mg/kg repeated dose ketamine (6 infusions, 3 per week for 2 weeks).
0.045mg/kg repeated dose midazolam (6 infusions, 3 per week for 2 weeks).
Overall Number of Participants Analyzed 15 15
Measure Type: Count of Participants
Unit of Measure: Participants
15
 100.0%
15
 100.0%
Time Frame up to 21 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Experimental Ketamine Group Active Control Midazolam Group
Hide Arm/Group Description 0.5mg/kg repeated dose ketamine (6 infusions, 3 per week for 2 weeks). 0.045mg/kg repeated dose midazolam (6 infusions, 3 per week for 2 weeks).
All-Cause Mortality
Experimental Ketamine Group Active Control Midazolam Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (0.00%)   0/15 (0.00%) 
Hide Serious Adverse Events
Experimental Ketamine Group Active Control Midazolam Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (0.00%)   0/15 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Experimental Ketamine Group Active Control Midazolam Group
Affected / at Risk (%) Affected / at Risk (%)
Total   15/15 (100.00%)   15/15 (100.00%) 
Cardiac disorders     
Palpitation † 1  1/15 (6.67%)  1/15 (6.67%) 
Eye disorders     
Blurred vision † 1  10/15 (66.67%)  0/15 (0.00%) 
Gastrointestinal disorders     
Diarrhea † 1  3/15 (20.00%)  4/15 (26.67%) 
Dry mouth † 1  2/15 (13.33%)  0/15 (0.00%) 
Nausea/Vomiting † 1  7/15 (46.67%)  6/15 (40.00%) 
General disorders     
Difficulty sleeping † 1  2/15 (13.33%)  0/15 (0.00%) 
Sleeping too much † 1  1/15 (6.67%)  0/15 (0.00%) 
Anxiety † 1  1/15 (6.67%)  0/15 (0.00%) 
Poor concentration † 1  4/15 (26.67%)  1/15 (6.67%) 
Fatigue † 1  7/15 (46.67%)  14/15 (93.33%) 
Decreased energy † 1  1/15 (6.67%)  1/15 (6.67%) 
Other † 1  15/15 (100.00%)  10/15 (66.67%) 
Nervous system disorders     
Headache † 1  7/15 (46.67%)  6/15 (40.00%) 
Tremors † 1  0/15 (0.00%)  1/15 (6.67%) 
Dizziness † 1  6/15 (40.00%)  2/15 (13.33%) 
Renal and urinary disorders     
Difficulty urinating † 1  1/15 (6.67%)  1/15 (6.67%) 
Painful urination † 1  0/15 (0.00%)  1/15 (6.67%) 
Frequent urination † 1  1/15 (6.67%)  0/15 (0.00%) 
Reproductive system and breast disorders     
Loss of sexual desire † 1  1/15 (6.67%)  0/15 (0.00%) 
Trouble achieving orgasm † 1  1/15 (6.67%)  0/15 (0.00%) 
Skin and subcutaneous tissue disorders     
Rash † 1  1/15 (6.67%)  0/15 (0.00%) 
Increased persipiration † 1  1/15 (6.67%)  0/15 (0.00%) 
Itching † 1  0/15 (0.00%)  1/15 (6.67%) 
1
Term from vocabulary, MedDRA (Unspecified)
†
Indicates events were collected by systematic assessment
Exclusion of patients with comorbid psychotic, bipolar, or current alcohol or substance use disorders to protect against worsening of psychotic symptoms or abuse potential, which may limit generalizability of our findings to individuals with PTSD and these comorbid disorders.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Adriana Feder
Organization: Icahn School of Medicine at Mount Sinai
Phone: 212-659-9279
EMail: adriana.feder@mssm.edu
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Adriana Feder, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT02397889    
Other Study ID Numbers: GCO 15-0265
First Submitted: March 19, 2015
First Posted: March 25, 2015
Results First Submitted: January 25, 2021
Results First Posted: February 11, 2021
Last Update Posted: March 11, 2021