CAP-Ketamine for Antidepressant Resistant PTSD

Study Overview
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Brief Summary
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The purpose of this study is to test the safety and efficacy of repeated doses of ketamine as compared to placebo, in reducing symptoms of Posttraumatic Stress Disorder (PTSD) in an active duty military and Veteran population.

Detailed Description
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In this 2-site clinical trial, intended to evaluate the safety and efficacy of repeated doses of ketamine for treatment resistant PTSD, Veterans and active duty military personnel who meet criteria for PTSD and the additional inclusion and exclusion criteria will be randomized to one of three treatment arms (placebo, low dose ketamine, high dose ketamine). Participants receive the study drug via intravenous infusion twice per week for 4-weeks.

Official Title
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CAP-Ketamine for Antidepressant Resistant PTSD

Conditions
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PTSD, Posttraumatic Stress Disorder

Intervention / Treatment
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* Drug: Ketamine
* Drug: Placebo/Saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: male or female Veterans or active duty military personnel between the ages of 18 and 70 years diagnosis of PTSD history of trialing one or more antidepressant medications with little to no PTSD symptom improvement ability to provide written informed consent Exclusion Criteria: females who are currently pregnant or breastfeeding current high risk for suicide history of severe head injury

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Saline dose | Drug: Placebo/Saline<br>* This is a saline placebo/non-active solution.<br>|
| Experimental: Low Dose Ketamine<br>Low Dose Ketamine (.20 mg/kg) | Drug: Ketamine<br>* FDA approved anesthetic medication with rapid acting antidepressant effects.<br>|
| Experimental: High Dose Ketamine<br>High Dose Ketamine (.50 mg/kg) | Drug: Ketamine<br>* FDA approved anesthetic medication with rapid acting antidepressant effects.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PTSD Checklist (PCL) | The PTSD Checklist (PCL) is a brief measure of the symptoms of Posttraumatic Stress Disorder (PTSD) to measure change in PTSD symptoms. The PCL-5 is a 20-item self-report measure, a total symptom severity score (range - 0-80) is obtained by summing the scores for each of the 20 items. (5-point Likert (0 = Not at all to 4 = Extremely). A total symptom severity score (range 0-80) with higher scores indicating greater severity for PTSD | Session 1 -Day 0 | 
| The PTSD Checklist (PCL) | The PTSD Checklist (PCL) is a brief measure of the symptoms of Posttraumatic Stress Disorder (PTSD) to measure change in PTSD symptoms. The PCL-5 is a 20-item self-report measure, a total symptom severity score (range - 0-80) is obtained by summing the scores for each of the 20 items. (5-point Likert (0 = Not at all to 4 = Extremely). A total symptom severity score (range 0-80) with higher scores indicating greater severity for PTSD | Session 2 - Day 1 | 
| The PTSD Checklist (PCL) | The PTSD Checklist (PCL) is a brief measure of the symptoms of Posttraumatic Stress Disorder (PTSD) to measure change in PTSD symptoms. The PCL-5 is a 20-item self-report measure, a total symptom severity score (range - 0-80) is obtained by summing the scores for each of the 20 items. (5-point Likert (0 = Not at all to 4 = Extremely). A total symptom severity score (range 0-80) with higher scores indicating greater severity for PTSD | Session 3 - Day 3 | 
| The PTSD Checklist (PCL) | The PTSD Checklist (PCL) is a brief measure of the symptoms of Posttraumatic Stress Disorder (PTSD) to measure change in PTSD symptoms. The PCL-5 is a 20-item self-report measure, a total symptom severity score (range - 0-80) is obtained by summing the scores for each of the 20 items. (5-point Likert (0 = Not at all to 4 = Extremely). A total symptom severity score (range 0-80) with higher scores indicating greater severity for PTSD | Session 4 - Day 7 | 
| The PTSD Checklist (PCL) | The PTSD Checklist (PCL) is a brief measure of the symptoms of Posttraumatic Stress Disorder (PTSD) to measure change in PTSD symptoms. The PCL-5 is a 20-item self-report measure, a total symptom severity score (range - 0-80) is obtained by summing the scores for each of the 20 items. (5-point Likert (0 = Not at all to 4 = Extremely). A total symptom severity score (range 0-80) with higher scores indicating greater severity for PTSD | Session 5 - Day 10 | 
| The PTSD Checklist (PCL) | The PTSD Checklist (PCL) is a brief measure of the symptoms of Posttraumatic Stress Disorder (PTSD) to measure change in PTSD symptoms. The PCL-5 is a 20-item self-report measure, a total symptom severity score (range - 0-80) is obtained by summing the scores for each of the 20 items. (5-point Likert (0 = Not at all to 4 = Extremely). A total symptom severity score (range 0-80) with higher scores indicating greater severity for PTSD | Session 6 - Day 14 | 
| The PTSD Checklist (PCL) | The PTSD Checklist (PCL) is a brief measure of the symptoms of Posttraumatic Stress Disorder (PTSD) to measure change in PTSD symptoms. The PCL-5 is a 20-item self-report measure, a total symptom severity score (range - 0-80) is obtained by summing the scores for each of the 20 items. (5-point Likert (0 = Not at all to 4 = Extremely). A total symptom severity score (range 0-80) with higher scores indicating greater severity for PTSD | Session 7 - Day 17 | 
| The PTSD Checklist (PCL) | The PTSD Checklist (PCL) is a brief measure of the symptoms of Posttraumatic Stress Disorder (PTSD) to measure change in PTSD symptoms. The PCL-5 is a 20-item self-report measure, a total symptom severity score (range - 0-80) is obtained by summing the scores for each of the 20 items. (5-point Likert (0 = Not at all to 4 = Extremely). A total symptom severity score (range 0-80) with higher scores indicating greater severity for PTSD | Session 8 - Day 21 | 
| The PTSD Checklist (PCL) | The PTSD Checklist (PCL) is a brief measure of the symptoms of Posttraumatic Stress Disorder (PTSD) to measure change in PTSD symptoms. The PCL-5 is a 20-item self-report measure, a total symptom severity score (range - 0-80) is obtained by summing the scores for each of the 20 items. (5-point Likert (0 = Not at all to 4 = Extremely). A total symptom severity score (range 0-80) with higher scores indicating greater severity for PTSD | Session 9 - Day 24 | 
| The PTSD Checklist (PCL) | The PTSD Checklist (PCL) is a brief measure of the symptoms of Posttraumatic Stress Disorder (PTSD) to measure change in PTSD symptoms. The PCL-5 is a 20-item self-report measure, a total symptom severity score (range - 0-80) is obtained by summing the scores for each of the 20 items. (5-point Likert (0 = Not at all to 4 = Extremely). A total symptom severity score (range 0-80) with higher scores indicating greater severity for PTSD | Follow-up 1 - Day 25 | 
| The PTSD Checklist (PCL) | The PTSD Checklist (PCL) is a brief measure of the symptoms of Posttraumatic Stress Disorder (PTSD) to measure change in PTSD symptoms. The PCL-5 is a 20-item self-report measure, a total symptom severity score (range - 0-80) is obtained by summing the scores for each of the 20 items. (5-point Likert (0 = Not at all to 4 = Extremely). A total symptom severity score (range 0-80) with higher scores indicating greater severity for PTSD | Follow-up 2 - Day 28 | 
| The PTSD Checklist (PCL) | The PTSD Checklist (PCL) is a brief measure of the symptoms of Posttraumatic Stress Disorder (PTSD) to measure change in PTSD symptoms. The PCL-5 is a 20-item self-report measure, a total symptom severity score (range - 0-80) is obtained by summing the scores for each of the 20 items. (5-point Likert (0 = Not at all to 4 = Extremely). A total symptom severity score (range 0-80) with higher scores indicating greater severity for PTSD | Follow-up 3 - Day 29 | 
| The PTSD Checklist (PCL) | The PTSD Checklist (PCL) is a brief measure of the symptoms of Posttraumatic Stress Disorder (PTSD) to measure change in PTSD symptoms. The PCL-5 is a 20-item self-report measure, a total symptom severity score (range - 0-80) is obtained by summing the scores for each of the 20 items. (5-point Likert (0 = Not at all to 4 = Extremely). A total symptom severity score (range 0-80) with higher scores indicating greater severity for PTSD | Follow-up 4 - Day 35 | 
| The PTSD Checklist (PCL) | The PTSD Checklist (PCL) is a brief measure of the symptoms of Posttraumatic Stress Disorder (PTSD) to measure change in PTSD symptoms. The PCL-5 is a 20-item self-report measure, a total symptom severity score (range - 0-80) is obtained by summing the scores for each of the 20 items. (5-point Likert (0 = Not at all to 4 = Extremely). A total symptom severity score (range 0-80) with higher scores indicating greater severity for PTSD | Follow-up 5 - Day 42 | 
| The PTSD Checklist (PCL) | The PTSD Checklist (PCL) is a brief measure of the symptoms of Posttraumatic Stress Disorder (PTSD) to measure change in PTSD symptoms. The PCL-5 is a 20-item self-report measure, a total symptom severity score (range - 0-80) is obtained by summing the scores for each of the 20 items. (5-point Likert (0 = Not at all to 4 = Extremely). A total symptom severity score (range 0-80) with higher scores indicating greater severity for PTSD | Follow-up 6 - Day 49 | 
| The PTSD Checklist (PCL) | The PTSD Checklist (PCL) is a brief measure of the symptoms of Posttraumatic Stress Disorder (PTSD) to measure change in PTSD symptoms. The PCL-5 is a 20-item self-report measure, a total symptom severity score (range - 0-80) is obtained by summing the scores for each of the 20 items. (5-point Likert (0 = Not at all to 4 = Extremely). A total symptom severity score (range 0-80) with higher scores indicating greater severity for PTSD | Follow-up 7 - Day 56 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Montgomery-Asberg Depression Rating Scale (MADRS) | Montgomery-Asberg Depression Rating Scale (MADRS) is a clinician rated ten-item diagnostic questionnaire to measure the severity of depression. The overall score ranges from 0 to 60 (0 to 6 - normal/symptom absent; 7 to 19 mild depression; 20 to 34 - moderate depression; >34 - severe depression) | Session 1 - Day 0 | 
| Montgomery-Asberg Depression Rating Scale (MADRS) | Montgomery-Asberg Depression Rating Scale (MADRS) is a clinician rated ten-item diagnostic questionnaire to measure the severity of depression. The overall score ranges from 0 to 60 (0 to 6 - normal/symptom absent; 7 to 19 mild depression; 20 to 34 - moderate depression; >34 - severe depression) | Session 2 - Day 1 | 
| Montgomery-Asberg Depression Rating Scale (MADRS) | Montgomery-Asberg Depression Rating Scale (MADRS) is a clinician rated ten-item diagnostic questionnaire to measure the severity of depression. The overall score ranges from 0 to 60 (0 to 6 - normal/symptom absent; 7 to 19 mild depression; 20 to 34 - moderate depression; >34 - severe depression) | Session 3 - Day 3 | 
| Montgomery-Asberg Depression Rating Scale (MADRS) | Montgomery-Asberg Depression Rating Scale (MADRS) is a clinician rated ten-item diagnostic questionnaire to measure the severity of depression. The overall score ranges from 0 to 60 (0 to 6 - normal/symptom absent; 7 to 19 mild depression; 20 to 34 - moderate depression; >34 - severe depression) | Session 4 - Day 7 | 
| Montgomery-Asberg Depression Rating Scale (MADRS) | Montgomery-Asberg Depression Rating Scale (MADRS) is a clinician rated ten-item diagnostic questionnaire to measure the severity of depression. The overall score ranges from 0 to 60 (0 to 6 - normal/symptom absent; 7 to 19 mild depression; 20 to 34 - moderate depression; >34 - severe depression) | Session 5 - Day 10 | 
| Montgomery-Asberg Depression Rating Scale (MADRS) | Montgomery-Asberg Depression Rating Scale (MADRS) is a clinician rated ten-item diagnostic questionnaire to measure the severity of depression. The overall score ranges from 0 to 60 (0 to 6 - normal/symptom absent; 7 to 19 mild depression; 20 to 34 - moderate depression; >34 - severe depression) | Session 6 - Day 14 | 
| Montgomery-Asberg Depression Rating Scale (MADRS) | Montgomery-Asberg Depression Rating Scale (MADRS) is a clinician rated ten-item diagnostic questionnaire to measure the severity of depression. The overall score ranges from 0 to 60 (0 to 6 - normal/symptom absent; 7 to 19 mild depression; 20 to 34 - moderate depression; >34 - severe depression) | Session 7 - Day 17 | 
| Montgomery-Asberg Depression Rating Scale (MADRS) | Montgomery-Asberg Depression Rating Scale (MADRS) is a clinician rated ten-item diagnostic questionnaire to measure the severity of depression. The overall score ranges from 0 to 60 (0 to 6 - normal/symptom absent; 7 to 19 mild depression; 20 to 34 - moderate depression; >34 - severe depression) | Session 8 - Day 21 | 
| Montgomery-Asberg Depression Rating Scale (MADRS) | Montgomery-Asberg Depression Rating Scale (MADRS) is a clinician rated ten-item diagnostic questionnaire to measure the severity of depression. The overall score ranges from 0 to 60 (0 to 6 - normal/symptom absent; 7 to 19 mild depression; 20 to 34 - moderate depression; >34 - severe depression) | Session 9 - Day 24 | 
| Montgomery-Asberg Depression Rating Scale (MADRS) | Montgomery-Asberg Depression Rating Scale (MADRS) is a clinician rated ten-item diagnostic questionnaire to measure the severity of depression. The overall score ranges from 0 to 60 (0 to 6 - normal/symptom absent; 7 to 19 mild depression; 20 to 34 - moderate depression; >34 - severe depression) | Follow-up 1 - Day 25 | 
| Montgomery-Asberg Depression Rating Scale (MADRS) | Montgomery-Asberg Depression Rating Scale (MADRS) is a clinician rated ten-item diagnostic questionnaire to measure the severity of depression. The overall score ranges from 0 to 60 (0 to 6 - normal/symptom absent; 7 to 19 mild depression; 20 to 34 - moderate depression; >34 - severe depression) | Follow-up 2 - Day 28 | 
| Montgomery-Asberg Depression Rating Scale (MADRS) | Montgomery-Asberg Depression Rating Scale (MADRS) is a clinician rated ten-item diagnostic questionnaire to measure the severity of depression. The overall score ranges from 0 to 60 (0 to 6 - normal/symptom absent; 7 to 19 mild depression; 20 to 34 - moderate depression; >34 - severe depression) | Follow-up 3 - Day 29 | 
| Montgomery-Asberg Depression Rating Scale (MADRS) | Montgomery-Asberg Depression Rating Scale (MADRS) is a clinician rated ten-item diagnostic questionnaire to measure the severity of depression. The overall score ranges from 0 to 60 (0 to 6 - normal/symptom absent; 7 to 19 mild depression; 20 to 34 - moderate depression; >34 - severe depression) | Follow-up 4 - Day 35 | 
| Montgomery-Asberg Depression Rating Scale (MADRS) | Montgomery-Asberg Depression Rating Scale (MADRS) is a clinician rated ten-item diagnostic questionnaire to measure the severity of depression. The overall score ranges from 0 to 60 (0 to 6 - normal/symptom absent; 7 to 19 mild depression; 20 to 34 - moderate depression; >34 - severe depression) | Follow-up 5 - Day 42 | 
| Montgomery-Asberg Depression Rating Scale (MADRS) | Montgomery-Asberg Depression Rating Scale (MADRS) is a clinician rated ten-item diagnostic questionnaire to measure the severity of depression. The overall score ranges from 0 to 60 (0 to 6 - normal/symptom absent; 7 to 19 mild depression; 20 to 34 - moderate depression; >34 - severe depression) | Follow-up 6 - Day 49 | 
| Montgomery-Asberg Depression Rating Scale (MADRS) | Montgomery-Asberg Depression Rating Scale (MADRS) is a clinician rated ten-item diagnostic questionnaire to measure the severity of depression. The overall score ranges from 0 to 60 (0 to 6 - normal/symptom absent; 7 to 19 mild depression; 20 to 34 - moderate depression; >34 - severe depression) | Follow-up 7 - Day 56 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PTSD, Ketamine, Veteran, Military, Clinical Trial