Posttraumatic Stress Disorder, PTSD
Conditions
Keywords
PTSD, Ketamine, Veteran, Military, Clinical Trial
Brief summary
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
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.
Interventions
DRUGKetamine
FDA approved anesthetic medication with rapid acting antidepressant effects.
DRUGPlacebo/Saline
This is a saline placebo/non-active solution.
Sponsors
The University of Texas Health Science Center at San Antonio
Brooke Army Medical Center
Minneapolis Veterans Affairs Medical Center
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PTSD Checklist (PCL) | Session 1 -Day 0 | 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 |
| The PTSD Checklist (PCL) | Session 2 - Day 1 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Montgomery-Asberg Depression Rating Scale (MADRS) | Session 1 - Day 0 | 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) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo Saline dose
Placebo: This is a saline placebo/non-active solution. | 54 |
| Low Dose Ketamine Low Dose Ketamine (.20 mg/kg)
Ketamine: FDA approved anesthetic medication with rapid acting antidepressant effects. | 53 |
| High Dose Ketamine High Dose Ketamine (.50 mg/kg)
Ketamine: FDA approved anesthetic medication with rapid acting antidepressant effects. | 51 |
| Total | 158 |
Baseline characteristics
| Characteristic | Placebo | Low Dose Ketamine | High Dose Ketamine | Total |
|---|---|---|---|---|
| Age, Continuous | 42 years STANDARD_DEVIATION 1.5 | 45 years STANDARD_DEVIATION 1.5 | 43 years STANDARD_DEVIATION 1.8 | 43.3 years STANDARD_DEVIATION 11.5 |
| PCL | 51.95 units on a scale STANDARD_DEVIATION 10.82 | 51.75 units on a scale STANDARD_DEVIATION 12.38 | 50.23 units on a scale STANDARD_DEVIATION 14.69 | 51.33 units on a scale STANDARD_DEVIATION 12.62 |
| Race/Ethnicity, Customized Black | 6 Participants | 7 Participants | 7 Participants | 20 Participants |
| Race/Ethnicity, Customized Hispanic | 8 Participants | 11 Participants | 12 Participants | 31 Participants |
| Race/Ethnicity, Customized Other | 3 Participants | 7 Participants | 3 Participants | 13 Participants |
| Race/Ethnicity, Customized White - non Hispanic | 37 Participants | 28 Participants | 29 Participants | 94 Participants |
| Sex: Female, Male Female | 14 Participants | 10 Participants | 13 Participants | 37 Participants |
| Sex: Female, Male Male | 40 Participants | 43 Participants | 38 Participants | 121 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 55 | 0 / 55 | 0 / 53 |
| other Total, other adverse events | 25 / 55 | 42 / 55 | 38 / 53 |
| serious Total, serious adverse events | 0 / 55 | 0 / 55 | 0 / 53 |
Outcome results
Primary
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
Time frame: Session 1 -Day 0
Population: The variability in the number of participants for data points resulted from a variety of reasons for example participants not showing up for appointments, dropping out of the study and/or illness.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | PTSD Checklist (PCL) | 48.56 units on a scale | Standard Deviation 12.76 |
| Low Dose Ketamine | PTSD Checklist (PCL) | 46.62 units on a scale | Standard Deviation 17.71 |
| High Dose Ketamine | PTSD Checklist (PCL) | 47.88 units on a scale | Standard Deviation 14.46 |
Primary
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
Time frame: Session 2 - Day 1
Population: The variability in the number of participants for data points resulted from a variety of reasons for example participants not showing up for appointments, dropping out of the study and/or illness.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | The PTSD Checklist (PCL) | 37.65 units on a scale | Standard Deviation 18.4 |
| Low Dose Ketamine | The PTSD Checklist (PCL) | 32.75 units on a scale | Standard Deviation 19.39 |
| High Dose Ketamine | The PTSD Checklist (PCL) | 30.10 units on a scale | Standard Deviation 20.25 |
Primary
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
Time frame: Session 3 - Day 3
Population: The variability in the number of participants for data points resulted from a variety of reasons for example participants not showing up for appointments, dropping out of the study and/or illness.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | The PTSD Checklist (PCL) | 36.90 units on a scale | Standard Deviation 18.11 |
| Low Dose Ketamine | The PTSD Checklist (PCL) | 33.66 units on a scale | Standard Deviation 18.67 |
| High Dose Ketamine | The PTSD Checklist (PCL) | 34.20 units on a scale | Standard Deviation 18.37 |
Primary
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
Time frame: Session 4 - Day 7
Population: The variability in the number of participants for data points resulted from a variety of reasons for example participants not showing up for appointments, dropping out of the study and/or illness.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | The PTSD Checklist (PCL) | 34.75 units on a scale | Standard Deviation 18.96 |
| Low Dose Ketamine | The PTSD Checklist (PCL) | 29.09 units on a scale | Standard Deviation 20.61 |
| High Dose Ketamine | The PTSD Checklist (PCL) | 32.58 units on a scale | Standard Deviation 19.12 |
Primary
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
Time frame: Session 5 - Day 10
Population: The variability in the number of participants for data points resulted from a variety of reasons for example participants not showing up for appointments, dropping out of the study and/or illness.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | The PTSD Checklist (PCL) | 35.11 units on a scale | Standard Deviation 18.84 |
| Low Dose Ketamine | The PTSD Checklist (PCL) | 28.51 units on a scale | Standard Deviation 21.12 |
| High Dose Ketamine | The PTSD Checklist (PCL) | 31.46 units on a scale | Standard Deviation 18.6 |
Primary
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
Time frame: Session 6 - Day 14
Population: The variability in the number of participants for data points resulted from a variety of reasons for example participants not showing up for appointments, dropping out of the study and/or illness.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | The PTSD Checklist (PCL) | 30.80 units on a scale | Standard Deviation 19.85 |
| Low Dose Ketamine | The PTSD Checklist (PCL) | 26.40 units on a scale | Standard Deviation 21.12 |
| High Dose Ketamine | The PTSD Checklist (PCL) | 27.91 units on a scale | Standard Deviation 17.04 |
Primary
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
Time frame: Session 7 - Day 17
Population: The variability in the number of participants for data points resulted from a variety of reasons for example participants not showing up for appointments, dropping out of the study and/or illness.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | The PTSD Checklist (PCL) | 28.48 units on a scale | Standard Deviation 19.47 |
| Low Dose Ketamine | The PTSD Checklist (PCL) | 24.13 units on a scale | Standard Deviation 20.15 |
| High Dose Ketamine | The PTSD Checklist (PCL) | 26.54 units on a scale | Standard Deviation 17.58 |
Primary
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
Time frame: Session 8 - Day 21
Population: The variability in the number of participants for data points resulted from a variety of reasons for example participants not showing up for appointments, dropping out of the study and/or illness.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | The PTSD Checklist (PCL) | 29.31 units on a scale | Standard Deviation 20.39 |
| Low Dose Ketamine | The PTSD Checklist (PCL) | 24.52 units on a scale | Standard Deviation 20.45 |
| High Dose Ketamine | The PTSD Checklist (PCL) | 26.73 units on a scale | Standard Deviation 17.2 |
Primary
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
Time frame: Session 9 - Day 24
Population: The variability in the number of participants for data points resulted from a variety of reasons for example participants not showing up for appointments, dropping out of the study and/or illness.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | The PTSD Checklist (PCL) | 28.31 units on a scale | Standard Deviation 19.89 |
| Low Dose Ketamine | The PTSD Checklist (PCL) | 21.94 units on a scale | Standard Deviation 20.35 |
| High Dose Ketamine | The PTSD Checklist (PCL) | 25.62 units on a scale | Standard Deviation 19.86 |
Primary
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
Time frame: Follow-up 1 - Day 25
Population: The variability in the number of participants for data points resulted from a variety of reasons for example participants not showing up for appointments, dropping out of the study and/or illness.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | The PTSD Checklist (PCL) | 27.34 units on a scale | Standard Deviation 20.25 |
| Low Dose Ketamine | The PTSD Checklist (PCL) | 21.35 units on a scale | Standard Deviation 20.7 |
| High Dose Ketamine | The PTSD Checklist (PCL) | 22.54 units on a scale | Standard Deviation 17.98 |
Primary
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
Time frame: Follow-up 2 - Day 28
Population: The variability in the number of participants for data points resulted from a variety of reasons for example participants not showing up for appointments, dropping out of the study and/or illness.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | The PTSD Checklist (PCL) | 37.84 units on a scale | Standard Deviation 18.37 |
| Low Dose Ketamine | The PTSD Checklist (PCL) | 34.59 units on a scale | Standard Deviation 18.45 |
| High Dose Ketamine | The PTSD Checklist (PCL) | 39.58 units on a scale | Standard Deviation 15.55 |
Primary
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
Time frame: Follow-up 3 - Day 29
Population: The variability in the number of participants for data points resulted from a variety of reasons for example participants not showing up for appointments, dropping out of the study and/or illness.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | The PTSD Checklist (PCL) | 33.79 units on a scale | Standard Deviation 19.8 |
| Low Dose Ketamine | The PTSD Checklist (PCL) | 33.72 units on a scale | Standard Deviation 20.17 |
| High Dose Ketamine | The PTSD Checklist (PCL) | 40.27 units on a scale | Standard Deviation 16.29 |
Primary
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
Time frame: Follow-up 4 - Day 35
Population: The variability in the number of participants for data points resulted from a variety of reasons for example participants not showing up for appointments, dropping out of the study and/or illness.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | The PTSD Checklist (PCL) | 26.92 units on a scale | Standard Deviation 19.17 |
| Low Dose Ketamine | The PTSD Checklist (PCL) | 22.84 units on a scale | Standard Deviation 21.46 |
| High Dose Ketamine | The PTSD Checklist (PCL) | 24.09 units on a scale | Standard Deviation 17.05 |
Primary
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
Time frame: Follow-up 5 - Day 42
Population: The variability in the number of participants for data points resulted from a variety of reasons for example participants not showing up for appointments, dropping out of the study and/or illness.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | The PTSD Checklist (PCL) | 28.14 units on a scale | Standard Deviation 20.92 |
| Low Dose Ketamine | The PTSD Checklist (PCL) | 25.62 units on a scale | Standard Deviation 21.81 |
| High Dose Ketamine | The PTSD Checklist (PCL) | 29.16 units on a scale | Standard Deviation 19.85 |
Primary
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
Time frame: Follow-up 6 - Day 49
Population: The variability in the number of participants for data points resulted from a variety of reasons for example participants not showing up for appointments, dropping out of the study and/or illness.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | The PTSD Checklist (PCL) | 30.71 units on a scale | Standard Deviation 21.33 |
| Low Dose Ketamine | The PTSD Checklist (PCL) | 24.90 units on a scale | Standard Deviation 20.66 |
| High Dose Ketamine | The PTSD Checklist (PCL) | 30.21 units on a scale | Standard Deviation 18.82 |
Primary
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
Time frame: Follow-up 7 - Day 56
Population: The variability in the number of participants for data points resulted from a variety of reasons for example participants not showing up for appointments, dropping out of the study and/or illness.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | The PTSD Checklist (PCL) | 31.90 units on a scale | Standard Deviation 21.08 |
| Low Dose Ketamine | The PTSD Checklist (PCL) | 24.32 units on a scale | Standard Deviation 21.15 |
| High Dose Ketamine | The PTSD Checklist (PCL) | 31.23 units on a scale | Standard Deviation 19.81 |
Secondary
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)
Time frame: Session 1 - Day 0
Population: The variability in the number of participants for data points resulted from a variety of reasons for example participants not showing up for appointments, dropping out of the study and/or illness.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Montgomery-Asberg Depression Rating Scale (MADRS) | 28.24 score on a scale | Standard Deviation 8.43 |
| Low Dose Ketamine | Montgomery-Asberg Depression Rating Scale (MADRS) | 27.81 score on a scale | Standard Deviation 10.3 |
| High Dose Ketamine | Montgomery-Asberg Depression Rating Scale (MADRS) | 27.84 score on a scale | Standard Deviation 9.3 |
Secondary
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)
Time frame: Session 2 - Day 1
Population: The variability in the number of participants for data points resulted from a variety of reasons for example participants not showing up for appointments, dropping out of the study and/or illness.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Montgomery-Asberg Depression Rating Scale (MADRS) | 17.75 score on a scale | Standard Deviation 11.16 |
| Low Dose Ketamine | Montgomery-Asberg Depression Rating Scale (MADRS) | 17.02 score on a scale | Standard Deviation 13.02 |
| High Dose Ketamine | Montgomery-Asberg Depression Rating Scale (MADRS) | 12.94 score on a scale | Standard Deviation 9.5 |
Secondary
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)
Time frame: Session 3 - Day 3
Population: The variability in the number of participants for data points resulted from a variety of reasons for example participants not showing up for appointments, dropping out of the study and/or illness.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Montgomery-Asberg Depression Rating Scale (MADRS) | 19.98 score on a scale | Standard Deviation 11.22 |
| Low Dose Ketamine | Montgomery-Asberg Depression Rating Scale (MADRS) | 19.34 score on a scale | Standard Deviation 12.77 |
| High Dose Ketamine | Montgomery-Asberg Depression Rating Scale (MADRS) | 17.86 score on a scale | Standard Deviation 11.55 |
Secondary
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)
Time frame: Session 4 - Day 7
Population: The variability in the number of participants for data points resulted from a variety of reasons for example participants not showing up for appointments, dropping out of the study and/or illness.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Montgomery-Asberg Depression Rating Scale (MADRS) | 19.94 score on a scale | Standard Deviation 11.64 |
| Low Dose Ketamine | Montgomery-Asberg Depression Rating Scale (MADRS) | 17.83 score on a scale | Standard Deviation 13.11 |
| High Dose Ketamine | Montgomery-Asberg Depression Rating Scale (MADRS) | 18.54 score on a scale | Standard Deviation 10.62 |
Secondary
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)
Time frame: Session 5 - Day 10
Population: The variability in the number of participants for data points resulted from a variety of reasons for example participants not showing up for appointments, dropping out of the study and/or illness.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Montgomery-Asberg Depression Rating Scale (MADRS) | 20.70 score on a scale | Standard Deviation 11.79 |
| Low Dose Ketamine | Montgomery-Asberg Depression Rating Scale (MADRS) | 16.64 score on a scale | Standard Deviation 12.9 |
| High Dose Ketamine | Montgomery-Asberg Depression Rating Scale (MADRS) | 18.07 score on a scale | Standard Deviation 9.98 |
Secondary
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)
Time frame: Session 6 - Day 14
Population: The variability in the number of participants for data points resulted from a variety of reasons for example participants not showing up for appointments, dropping out of the study and/or illness.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Montgomery-Asberg Depression Rating Scale (MADRS) | 18.36 score on a scale | Standard Deviation 11.9 |
| Low Dose Ketamine | Montgomery-Asberg Depression Rating Scale (MADRS) | 16.71 score on a scale | Standard Deviation 13.47 |
| High Dose Ketamine | Montgomery-Asberg Depression Rating Scale (MADRS) | 16.83 score on a scale | Standard Deviation 9.91 |
Secondary
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)
Time frame: Session 7 - Day 17
Population: The variability in the number of participants for data points resulted from a variety of reasons for example participants not showing up for appointments, dropping out of the study and/or illness.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Montgomery-Asberg Depression Rating Scale (MADRS) | 17.02 score on a scale | Standard Deviation 12.52 |
| Low Dose Ketamine | Montgomery-Asberg Depression Rating Scale (MADRS) | 14.75 score on a scale | Standard Deviation 12.98 |
| High Dose Ketamine | Montgomery-Asberg Depression Rating Scale (MADRS) | 15.15 score on a scale | Standard Deviation 10.35 |
Secondary
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)
Time frame: Session 8 - Day 21
Population: The variability in the number of participants for data points resulted from a variety of reasons for example participants not showing up for appointments, dropping out of the study and/or illness.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Montgomery-Asberg Depression Rating Scale (MADRS) | 17.02 score on a scale | Standard Deviation 12.52 |
| Low Dose Ketamine | Montgomery-Asberg Depression Rating Scale (MADRS) | 16.44 score on a scale | Standard Deviation 13.66 |
| High Dose Ketamine | Montgomery-Asberg Depression Rating Scale (MADRS) | 15.78 score on a scale | Standard Deviation 11.59 |
Secondary
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)
Time frame: Session 9 - Day 24
Population: The variability in the number of participants for data points resulted from a variety of reasons for example participants not showing up for appointments, dropping out of the study and/or illness.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Montgomery-Asberg Depression Rating Scale (MADRS) | 17.11 score on a scale | Standard Deviation 11.75 |
| Low Dose Ketamine | Montgomery-Asberg Depression Rating Scale (MADRS) | 14.43 score on a scale | Standard Deviation 12.29 |
| High Dose Ketamine | Montgomery-Asberg Depression Rating Scale (MADRS) | 14.24 score on a scale | Standard Deviation 10.59 |
Secondary
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)
Time frame: Follow-up 1 - Day 25
Population: The variability in the number of participants for data points resulted from a variety of reasons for example participants not showing up for appointments, dropping out of the study and/or illness.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Montgomery-Asberg Depression Rating Scale (MADRS) | 15.98 score on a scale | Standard Deviation 12.32 |
| Low Dose Ketamine | Montgomery-Asberg Depression Rating Scale (MADRS) | 12.91 score on a scale | Standard Deviation 12.6 |
| High Dose Ketamine | Montgomery-Asberg Depression Rating Scale (MADRS) | 10.78 score on a scale | Standard Deviation 9.85 |
Secondary
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)
Time frame: Follow-up 2 - Day 28
Population: The variability in the number of participants for data points resulted from a variety of reasons for example participants not showing up for appointments, dropping out of the study and/or illness.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Montgomery-Asberg Depression Rating Scale (MADRS) | 24.00 score on a scale | Standard Deviation 10.3 |
| Low Dose Ketamine | Montgomery-Asberg Depression Rating Scale (MADRS) | 25.11 score on a scale | Standard Deviation 12.2 |
| High Dose Ketamine | Montgomery-Asberg Depression Rating Scale (MADRS) | 25.08 score on a scale | Standard Deviation 7.34 |
Secondary
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)
Time frame: Follow-up 3 - Day 29
Population: The variability in the number of participants for data points resulted from a variety of reasons for example participants not showing up for appointments, dropping out of the study and/or illness.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Montgomery-Asberg Depression Rating Scale (MADRS) | 15.00 score on a scale | Standard Deviation 11.55 |
| Low Dose Ketamine | Montgomery-Asberg Depression Rating Scale (MADRS) | 19.18 score on a scale | Standard Deviation 13.99 |
| High Dose Ketamine | Montgomery-Asberg Depression Rating Scale (MADRS) | 20.27 score on a scale | Standard Deviation 8.32 |
Secondary
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)
Time frame: Follow-up 4 - Day 35
Population: The variability in the number of participants for data points resulted from a variety of reasons for example participants not showing up for appointments, dropping out of the study and/or illness.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Montgomery-Asberg Depression Rating Scale (MADRS) | 16.08 score on a scale | Standard Deviation 11.15 |
| Low Dose Ketamine | Montgomery-Asberg Depression Rating Scale (MADRS) | 14.43 score on a scale | Standard Deviation 12.71 |
| High Dose Ketamine | Montgomery-Asberg Depression Rating Scale (MADRS) | 12.72 score on a scale | Standard Deviation 9.24 |
Secondary
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)
Time frame: Follow-up 5 - Day 42
Population: The variability in the number of participants for data points resulted from a variety of reasons for example participants not showing up for appointments, dropping out of the study and/or illness.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Montgomery-Asberg Depression Rating Scale (MADRS) | 16.89 score on a scale | Standard Deviation 12.51 |
| Low Dose Ketamine | Montgomery-Asberg Depression Rating Scale (MADRS) | 15.74 score on a scale | Standard Deviation 13.03 |
| High Dose Ketamine | Montgomery-Asberg Depression Rating Scale (MADRS) | 16.42 score on a scale | Standard Deviation 9.39 |
Secondary
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)
Time frame: Follow-up 6 - Day 49
Population: The variability in the number of participants for data points resulted from a variety of reasons for example participants not showing up for appointments, dropping out of the study and/or illness.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Montgomery-Asberg Depression Rating Scale (MADRS) | 19.60 score on a scale | Standard Deviation 11.52 |
| Low Dose Ketamine | Montgomery-Asberg Depression Rating Scale (MADRS) | 15.87 score on a scale | Standard Deviation 11.79 |
| High Dose Ketamine | Montgomery-Asberg Depression Rating Scale (MADRS) | 17.68 score on a scale | Standard Deviation 8.86 |
Secondary
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)
Time frame: Follow-up 7 - Day 56
Population: The variability in the number of participants for data points resulted from a variety of reasons for example participants not showing up for appointments, dropping out of the study and/or illness.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Montgomery-Asberg Depression Rating Scale (MADRS) | 19.45 score on a scale | Standard Deviation 11.19 |
| Low Dose Ketamine | Montgomery-Asberg Depression Rating Scale (MADRS) | 15.44 score on a scale | Standard Deviation 12.98 |
| High Dose Ketamine | Montgomery-Asberg Depression Rating Scale (MADRS) | 19.58 score on a scale | Standard Deviation 10.94 |