Major Depressive Disorder, Orthopedic Disorder, Surgery
Conditions
Keywords
depression, ketamine, anesthesia, total joint arthroplasty
Brief summary
This study evaluates whether ketamine, given as part of an anesthetic, improves depression symptoms in depressed patients undergoing non-cardiac surgery. Half of participants will receive a ketamine infusion during surgery, while the other half will receive a placebo (normal saline) during surgery.
Detailed description
Major Depressive Disorder (MDD) is widely prevalent among patients preparing to have surgery, and is a known risk factor for complications after surgery, including wound infection, myocardial infarction and opioid use disorder. Ketamine has emerged as an effective, rapid-acting antidepressant therapy for patients with MDD, and may be a useful tool to prevent MDD-related morbidity in the perioperative period. Ketamine has been well studied for MDD in outpatient clinics where it is given as an infusion (0.5 mg/kg over 40 minutes) in awake patients. Ketamine is often used as part of an anesthetic cocktail in sedated or anesthetized patients, but it is unknown whether ketamine has an antidepressant effect in this context. The investigators will determine whether a ketamine infusion, compared to placebo (normal saline infusion), has an antidepressant effect when given during surgical anesthesia. If ketamine is an effective antidepressant in this population under anesthesia, its use could be incorporated into a set of interventions to minimize the perioperative complications associated with MDD.
Interventions
DRUGKetamine
0.5 mg/kg over 40 minutes, intravenous.
DRUGNormal saline (placebo)
Normal saline infusion over 40 minutes, equivalent volume to ketamine infusion.
Sponsors
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Masking is for double blind phase only.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patient presenting for non-cardiac, non-intracranial surgery * Major Depressive Disorder
Exclusion criteria
* Pregnant of breastfeeding women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Montgomery-Asberg Depression Rating Scale (MADRS) Score | Post-intervention days 1, 2 and 3 | The MADRS is a 10-item scale for the evaluation of depressive symptoms (Montgomery et al 1979). Each MADRS item is rated on a 0 to 6 scale. Total score range from 0-60, where lower MADRS scores indicate lower levels of depressive symptoms. The assessment for this outcome will be taken once daily on days 1, 2 and 3 post procedure. A mixed model for repeated measures (MMRM) was used to analyze the difference in postoperative MADRS score between ketamine and placebo groups.. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Remission | Post-intervention day 14 | Remission defined as a MADRS score of \<=12 on day 14. MADRS score range: 0 to 60, a lower score indicates lower severity of symptoms. |
| Hospital Anxiety and Depression Scale (HADS) Scale Score | Post-intervention days 1, 2, 3, 5, 7 and 14 | This outcome measures self-reported symptoms of anxiety and depression on a scale that ranges from 0 to 42. A lower score indicates lower severity of symptoms. |
| Cumulative Opioid Use | Post-intervention days 1, 2, 3, 5, 7 and 14 | This outcome measures how many cumulative morphine-equivalents milligrams of opioid pain medication the patient has taken as an inpatient and after discharge from hospital |
| Number of Participants With Clinical Response | Post-intervention days 1, 2 and 3 | Clinical response defined as \>=50% reduction in MADRS score from baseline. MADRS score range: 0 to 60, a lower score indicates lower severity of symptoms. |
| Brief Pain Inventory Pain Intensity Scale Score | Post-intervention days 1, 2, 3, 5, 7 and 14 | Average pain intensity in the past 24 hours, rated on a numerical scale from 0 to 10 (with 0 representing No pain and 10 representing Pain as bad as you can imagine). |
| Brief Pain Inventory Pain Interference Scale Score | Post-intervention days 1, 2, 3, 5, 7 and 14 | Pain interference in the past 24 hours, rated on a numerical scale from 0 to 10 (with 0 representing Does not interfere and 10 representing Completely interferes). |
| Hospital Length of Stay | Average approximately 3 days post-intervention | Number of days from admission (day of surgery) through discharge after surgery. |
Countries
United States
Participant flow
Recruitment details
For the open-label arm, recruitment occurred between August 2019 and March 2020. For the double-blind arms, recruitment occurred between February 2020 and August 2022. In all arms, recruitment occurred in medical clinics and by telephone and video visits.
Pre-assignment details
Five participants were recruited for an open label study to evaluate and optimize study procedures prior to randomizing participants enrolled in the double-blind trial (Double blind ketamine vs Double blind placebo).
Participants by arm
| Arm | Count |
|---|---|
| Open Label Ketamine Patients received intravenous ketamine (0.5 mg/kg over 40 minutes) infusion during surgery. | 5 |
| Double Blind Ketamine Patients received intravenous ketamine (0.5 mg/kg over 40 minutes) infusion during surgery. | 20 |
| Double Blind Placebo Participants received placebo (normal saline infusion over 40 minutes) during surgery. | 20 |
| Total | 45 |
Baseline characteristics
| Characteristic | Open Label Ketamine | Total | Double Blind Placebo | Double Blind Ketamine |
|---|---|---|---|---|
| Age, Continuous | 62.3 years STANDARD_DEVIATION 6.4 | 52.4 years STANDARD_DEVIATION 15.3 | 51.9 years STANDARD_DEVIATION 18.9 | 50.5 years STANDARD_DEVIATION 12 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 4 Participants | 2 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 4 Participants | 39 Participants | 17 Participants | 18 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 2 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 4 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 5 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) White | 5 Participants | 31 Participants | 13 Participants | 13 Participants |
| Region of Enrollment United States | 5 Participants | 45 Participants | 20 Participants | 20 Participants |
| Sex: Female, Male Female | 3 Participants | 31 Participants | 16 Participants | 12 Participants |
| Sex: Female, Male Male | 2 Participants | 14 Participants | 4 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 5 | 1 / 20 | 0 / 20 |
| other Total, other adverse events | 1 / 5 | 7 / 20 | 6 / 20 |
| serious Total, serious adverse events | 0 / 5 | 1 / 20 | 2 / 20 |
Outcome results
Primary
Montgomery-Asberg Depression Rating Scale (MADRS) Score
The MADRS is a 10-item scale for the evaluation of depressive symptoms (Montgomery et al 1979). Each MADRS item is rated on a 0 to 6 scale. Total score range from 0-60, where lower MADRS scores indicate lower levels of depressive symptoms. The assessment for this outcome will be taken once daily on days 1, 2 and 3 post procedure. A mixed model for repeated measures (MMRM) was used to analyze the difference in postoperative MADRS score between ketamine and placebo groups..
Time frame: Post-intervention days 1, 2 and 3
Population: Missing data occurred when the number of participants analyzed on specific days was fewer than the overall number of participants analyzed. This situation arose when some participants did not complete the instrument.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Open Label Ketamine | Montgomery-Asberg Depression Rating Scale (MADRS) Score | Day 2 | 25.4 score on a scale | Standard Deviation 17.3 |
| Open Label Ketamine | Montgomery-Asberg Depression Rating Scale (MADRS) Score | Day 3 | 10.5 score on a scale | Standard Deviation 7.1 |
| Open Label Ketamine | Montgomery-Asberg Depression Rating Scale (MADRS) Score | Day 1 | 17.0 score on a scale | Standard Deviation 13 |
| Double Blind Ketamine | Montgomery-Asberg Depression Rating Scale (MADRS) Score | Day 3 | 17.0 score on a scale | Standard Deviation 10.5 |
| Double Blind Ketamine | Montgomery-Asberg Depression Rating Scale (MADRS) Score | Day 1 | 12.7 score on a scale | Standard Deviation 7.6 |
| Double Blind Ketamine | Montgomery-Asberg Depression Rating Scale (MADRS) Score | Day 2 | 15.1 score on a scale | Standard Deviation 11.1 |
| Double Blind Placebo | Montgomery-Asberg Depression Rating Scale (MADRS) Score | Day 2 | 17.5 score on a scale | Standard Deviation 11.5 |
| Double Blind Placebo | Montgomery-Asberg Depression Rating Scale (MADRS) Score | Day 3 | 17.2 score on a scale | Standard Deviation 12 |
| Double Blind Placebo | Montgomery-Asberg Depression Rating Scale (MADRS) Score | Day 1 | 16.4 score on a scale | Standard Deviation 17.5 |
p-value: 0.13Mixed Models Analysis
Secondary
Brief Pain Inventory Pain Intensity Scale Score
Average pain intensity in the past 24 hours, rated on a numerical scale from 0 to 10 (with 0 representing No pain and 10 representing Pain as bad as you can imagine).
Time frame: Post-intervention days 1, 2, 3, 5, 7 and 14
Population: Missing data occurred when the number of participants analyzed on specific days was fewer than the overall number of participants analyzed. This situation arose when some participants did not complete the instrument.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Open Label Ketamine | Brief Pain Inventory Pain Intensity Scale Score | Day 1 | 4.6 score on a scale | Standard Deviation 1.8 |
| Open Label Ketamine | Brief Pain Inventory Pain Intensity Scale Score | Day 2 | 5.5 score on a scale | Standard Deviation 2.5 |
| Open Label Ketamine | Brief Pain Inventory Pain Intensity Scale Score | Day 3 | 3.5 score on a scale | Standard Deviation 3 |
| Open Label Ketamine | Brief Pain Inventory Pain Intensity Scale Score | Day 5 | 4.4 score on a scale | Standard Deviation 2.3 |
| Open Label Ketamine | Brief Pain Inventory Pain Intensity Scale Score | Day 7 | 4.8 score on a scale | Standard Deviation 2.4 |
| Open Label Ketamine | Brief Pain Inventory Pain Intensity Scale Score | Day 14 | 4.4 score on a scale | Standard Deviation 3 |
| Double Blind Ketamine | Brief Pain Inventory Pain Intensity Scale Score | Day 14 | 4.8 score on a scale | Standard Deviation 1.5 |
| Double Blind Ketamine | Brief Pain Inventory Pain Intensity Scale Score | Day 1 | 6.0 score on a scale | Standard Deviation 2 |
| Double Blind Ketamine | Brief Pain Inventory Pain Intensity Scale Score | Day 5 | 5.5 score on a scale | Standard Deviation 1.7 |
| Double Blind Ketamine | Brief Pain Inventory Pain Intensity Scale Score | Day 7 | 5.1 score on a scale | Standard Deviation 2.2 |
| Double Blind Ketamine | Brief Pain Inventory Pain Intensity Scale Score | Day 2 | 5.3 score on a scale | Standard Deviation 2.1 |
| Double Blind Ketamine | Brief Pain Inventory Pain Intensity Scale Score | Day 3 | 5.5 score on a scale | Standard Deviation 1.9 |
| Double Blind Placebo | Brief Pain Inventory Pain Intensity Scale Score | Day 2 | 6.0 score on a scale | Standard Deviation 2.3 |
| Double Blind Placebo | Brief Pain Inventory Pain Intensity Scale Score | Day 3 | 5.2 score on a scale | Standard Deviation 2.4 |
| Double Blind Placebo | Brief Pain Inventory Pain Intensity Scale Score | Day 14 | 3.7 score on a scale | Standard Deviation 2 |
| Double Blind Placebo | Brief Pain Inventory Pain Intensity Scale Score | Day 5 | 4.4 score on a scale | Standard Deviation 2.3 |
| Double Blind Placebo | Brief Pain Inventory Pain Intensity Scale Score | Day 1 | 5.2 score on a scale | Standard Deviation 2.8 |
| Double Blind Placebo | Brief Pain Inventory Pain Intensity Scale Score | Day 7 | 4.4 score on a scale | Standard Deviation 2.4 |
Secondary
Brief Pain Inventory Pain Interference Scale Score
Pain interference in the past 24 hours, rated on a numerical scale from 0 to 10 (with 0 representing Does not interfere and 10 representing Completely interferes).
Time frame: Post-intervention days 1, 2, 3, 5, 7 and 14
Population: Missing data occurred when the number of participants analyzed on specific days was fewer than the overall number of participants analyzed. This situation arose when some participants did not complete the instrument.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Open Label Ketamine | Brief Pain Inventory Pain Interference Scale Score | Day 7 | 7.6 units on a scale | Standard Deviation 3.8 |
| Open Label Ketamine | Brief Pain Inventory Pain Interference Scale Score | Day 14 | 4.8 units on a scale | Standard Deviation 3.1 |
| Open Label Ketamine | Brief Pain Inventory Pain Interference Scale Score | Day 5 | 6.6 units on a scale | Standard Deviation 4.3 |
| Open Label Ketamine | Brief Pain Inventory Pain Interference Scale Score | Day 3 | 4.8 units on a scale | Standard Deviation 2.2 |
| Open Label Ketamine | Brief Pain Inventory Pain Interference Scale Score | Day 1 | 6.0 units on a scale | Standard Deviation 2.7 |
| Open Label Ketamine | Brief Pain Inventory Pain Interference Scale Score | Day 2 | 6.3 units on a scale | Standard Deviation 3 |
| Double Blind Ketamine | Brief Pain Inventory Pain Interference Scale Score | Day 1 | 8.1 units on a scale | Standard Deviation 2.6 |
| Double Blind Ketamine | Brief Pain Inventory Pain Interference Scale Score | Day 7 | 6.7 units on a scale | Standard Deviation 2.8 |
| Double Blind Ketamine | Brief Pain Inventory Pain Interference Scale Score | Day 2 | 8.0 units on a scale | Standard Deviation 2.5 |
| Double Blind Ketamine | Brief Pain Inventory Pain Interference Scale Score | Day 5 | 7.0 units on a scale | Standard Deviation 3 |
| Double Blind Ketamine | Brief Pain Inventory Pain Interference Scale Score | Day 14 | 6.2 units on a scale | Standard Deviation 2.2 |
| Double Blind Ketamine | Brief Pain Inventory Pain Interference Scale Score | Day 3 | 7.5 units on a scale | Standard Deviation 2.6 |
| Double Blind Placebo | Brief Pain Inventory Pain Interference Scale Score | Day 14 | 5.7 units on a scale | Standard Deviation 3.5 |
| Double Blind Placebo | Brief Pain Inventory Pain Interference Scale Score | Day 1 | 7.6 units on a scale | Standard Deviation 3.2 |
| Double Blind Placebo | Brief Pain Inventory Pain Interference Scale Score | Day 2 | 8.1 units on a scale | Standard Deviation 2.1 |
| Double Blind Placebo | Brief Pain Inventory Pain Interference Scale Score | Day 3 | 7.7 units on a scale | Standard Deviation 2.8 |
| Double Blind Placebo | Brief Pain Inventory Pain Interference Scale Score | Day 5 | 7.0 units on a scale | Standard Deviation 2.9 |
| Double Blind Placebo | Brief Pain Inventory Pain Interference Scale Score | Day 7 | 7.2 units on a scale | Standard Deviation 3.1 |
Secondary
Cumulative Opioid Use
This outcome measures how many cumulative morphine-equivalents milligrams of opioid pain medication the patient has taken as an inpatient and after discharge from hospital
Time frame: Post-intervention days 1, 2, 3, 5, 7 and 14
Population: In the open-label group, total opioid consumption was recorded only for the first 3 postoperative days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Open Label Ketamine | Cumulative Opioid Use | Day 2 | 249.3 milligram morphine equivalents | Standard Deviation 173.2 |
| Open Label Ketamine | Cumulative Opioid Use | Day 1 | 108.5 milligram morphine equivalents | Standard Deviation 72.2 |
| Open Label Ketamine | Cumulative Opioid Use | Day 3 | 361.5 milligram morphine equivalents | Standard Deviation 237.3 |
| Double Blind Ketamine | Cumulative Opioid Use | Day 3 | 137.9 milligram morphine equivalents | Standard Deviation 165.9 |
| Double Blind Ketamine | Cumulative Opioid Use | Day 1 | 60.9 milligram morphine equivalents | Standard Deviation 60.3 |
| Double Blind Ketamine | Cumulative Opioid Use | Day 2 | 104.6 milligram morphine equivalents | Standard Deviation 109 |
| Double Blind Ketamine | Cumulative Opioid Use | Day 5 | 150.6 milligram morphine equivalents | Standard Deviation 204.3 |
| Double Blind Ketamine | Cumulative Opioid Use | Day 7 | 171.6 milligram morphine equivalents | Standard Deviation 219 |
| Double Blind Ketamine | Cumulative Opioid Use | Day 14 | 206.1 milligram morphine equivalents | Standard Deviation 270.1 |
| Double Blind Placebo | Cumulative Opioid Use | Day 7 | 163.3 milligram morphine equivalents | Standard Deviation 221.4 |
| Double Blind Placebo | Cumulative Opioid Use | Day 5 | 156.2 milligram morphine equivalents | Standard Deviation 218.7 |
| Double Blind Placebo | Cumulative Opioid Use | Day 14 | 186.4 milligram morphine equivalents | Standard Deviation 242.3 |
| Double Blind Placebo | Cumulative Opioid Use | Day 2 | 107.7 milligram morphine equivalents | Standard Deviation 126.3 |
| Double Blind Placebo | Cumulative Opioid Use | Day 1 | 56.1 milligram morphine equivalents | Standard Deviation 61.5 |
| Double Blind Placebo | Cumulative Opioid Use | Day 3 | 144.3 milligram morphine equivalents | Standard Deviation 188.4 |
Secondary
Hospital Anxiety and Depression Scale (HADS) Scale Score
This outcome measures self-reported symptoms of anxiety and depression on a scale that ranges from 0 to 42. A lower score indicates lower severity of symptoms.
Time frame: Post-intervention days 1, 2, 3, 5, 7 and 14
Population: Missing data occurred when the number of participants analyzed on specific days was fewer than the overall number of participants analyzed. This situation arose when some participants did not complete the instrument.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Open Label Ketamine | Hospital Anxiety and Depression Scale (HADS) Scale Score | Day 1 | 14.8 score on a scale | Standard Deviation 8.4 |
| Open Label Ketamine | Hospital Anxiety and Depression Scale (HADS) Scale Score | Day 2 | 22.6 score on a scale | Standard Deviation 12.7 |
| Open Label Ketamine | Hospital Anxiety and Depression Scale (HADS) Scale Score | Day 3 | 13.0 score on a scale | Standard Deviation 9.2 |
| Open Label Ketamine | Hospital Anxiety and Depression Scale (HADS) Scale Score | Day 5 | 16.6 score on a scale | Standard Deviation 10.2 |
| Open Label Ketamine | Hospital Anxiety and Depression Scale (HADS) Scale Score | Day 7 | 19.2 score on a scale | Standard Deviation 10 |
| Open Label Ketamine | Hospital Anxiety and Depression Scale (HADS) Scale Score | Day 14 | 14.0 score on a scale | Standard Deviation 9.7 |
| Double Blind Ketamine | Hospital Anxiety and Depression Scale (HADS) Scale Score | Day 14 | 16.4 score on a scale | Standard Deviation 7.2 |
| Double Blind Ketamine | Hospital Anxiety and Depression Scale (HADS) Scale Score | Day 1 | 17.8 score on a scale | Standard Deviation 6.6 |
| Double Blind Ketamine | Hospital Anxiety and Depression Scale (HADS) Scale Score | Day 5 | 18.3 score on a scale | Standard Deviation 4.8 |
| Double Blind Ketamine | Hospital Anxiety and Depression Scale (HADS) Scale Score | Day 7 | 18.4 score on a scale | Standard Deviation 5.3 |
| Double Blind Ketamine | Hospital Anxiety and Depression Scale (HADS) Scale Score | Day 2 | 18.8 score on a scale | Standard Deviation 7.5 |
| Double Blind Ketamine | Hospital Anxiety and Depression Scale (HADS) Scale Score | Day 3 | 19.3 score on a scale | Standard Deviation 6.3 |
| Double Blind Placebo | Hospital Anxiety and Depression Scale (HADS) Scale Score | Day 2 | 21.2 score on a scale | Standard Deviation 5.9 |
| Double Blind Placebo | Hospital Anxiety and Depression Scale (HADS) Scale Score | Day 3 | 20.8 score on a scale | Standard Deviation 5.4 |
| Double Blind Placebo | Hospital Anxiety and Depression Scale (HADS) Scale Score | Day 14 | 17.2 score on a scale | Standard Deviation 8.5 |
| Double Blind Placebo | Hospital Anxiety and Depression Scale (HADS) Scale Score | Day 5 | 18.9 score on a scale | Standard Deviation 7.3 |
| Double Blind Placebo | Hospital Anxiety and Depression Scale (HADS) Scale Score | Day 1 | 19.9 score on a scale | Standard Deviation 5.5 |
| Double Blind Placebo | Hospital Anxiety and Depression Scale (HADS) Scale Score | Day 7 | 19.6 score on a scale | Standard Deviation 8.1 |
Secondary
Hospital Length of Stay
Number of days from admission (day of surgery) through discharge after surgery.
Time frame: Average approximately 3 days post-intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Open Label Ketamine | Hospital Length of Stay | 3.7 days | Standard Deviation 0.9 |
| Double Blind Ketamine | Hospital Length of Stay | 1.9 days | Standard Deviation 1.7 |
| Double Blind Placebo | Hospital Length of Stay | 4.0 days | Standard Deviation 3.3 |
Secondary
Number of Participants With Clinical Response
Clinical response defined as \>=50% reduction in MADRS score from baseline. MADRS score range: 0 to 60, a lower score indicates lower severity of symptoms.
Time frame: Post-intervention days 1, 2 and 3
Population: Includes all participants still enrolled in the trial
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Open Label Ketamine | Number of Participants With Clinical Response | Day 2 | 1 Participants |
| Open Label Ketamine | Number of Participants With Clinical Response | Day 1 | 2 Participants |
| Open Label Ketamine | Number of Participants With Clinical Response | Day 3 | 3 Participants |
| Double Blind Ketamine | Number of Participants With Clinical Response | Day 2 | 10 Participants |
| Double Blind Ketamine | Number of Participants With Clinical Response | Day 1 | 12 Participants |
| Double Blind Ketamine | Number of Participants With Clinical Response | Day 3 | 9 Participants |
| Double Blind Placebo | Number of Participants With Clinical Response | Day 1 | 10 Participants |
| Double Blind Placebo | Number of Participants With Clinical Response | Day 3 | 10 Participants |
| Double Blind Placebo | Number of Participants With Clinical Response | Day 2 | 12 Participants |
Secondary
Number of Participants With Remission
Remission defined as a MADRS score of \<=12 on day 14. MADRS score range: 0 to 60, a lower score indicates lower severity of symptoms.
Time frame: Post-intervention day 14
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Open Label Ketamine | Number of Participants With Remission | 3 Participants |
| Double Blind Ketamine | Number of Participants With Remission | 8 Participants |
| Double Blind Placebo | Number of Participants With Remission | 10 Participants |