Trial Outcomes & Findings for Ketamine and Nitroprusside for Depression (NCT NCT03102736)
NCT ID: NCT03102736
Last Updated: 2020-07-02
Results Overview
This is a 10-item instrument used for the evaluation of depressive symptoms in adults and for the assessment of any changes to those symptoms. Each of the 10 items is rated on a scale of 0 to 6, with differing descriptors for each item. These individual item scores are added together to form a total score, which can range between 0 (normal) and 60 (severe depression).
COMPLETED
PHASE2
40 participants
24 hours after start of infusion
2020-07-02
Participant Flow
40 participants enrolled, 14 were excluded before starting the study and 10 were excluded after starting the study but before randomization (6 were ketamine non-responder, 2, failed to return to baseline, and 2 withdrew before randomization)
Participant milestones
| Measure |
Placebo and Ketamine
Placebo saline given over 240 minutes + 0.5 mg/kg ketamine given over the last 40 minutes of the infusion
|
Nitroprusside and Ketamine
0.5 mcg/kg/min nitroprusside given over 240 min (4 hours) - 0.5 mg/kg ketamine given over the last 40 min of the nitroprusside infusion (starting at minute 200 the two drugs are given together)
|
|---|---|---|
|
Overall Study
STARTED
|
7
|
9
|
|
Overall Study
COMPLETED
|
7
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Ketamine and Nitroprusside for Depression
Baseline characteristics by cohort
| Measure |
Placebo and Ketamine
n=7 Participants
Placebo saline given over 240 minutes + 0.5 mg/kg ketamine given over the last 40 minutes of the infusion
|
Nitroprusside and Ketamine
n=9 Participants
0.5 mcg/kg/min nitroprusside given over 240 min (4 hours) - 0.5 mg/kg ketamine given over the last 40 min of the nitroprusside infusion (starting at minute 200 the two drugs are given together)
|
Total
n=16 Participants
Total of all reporting groups
|
|---|---|---|---|
|
QIDS
|
17.6 units on a scale
STANDARD_DEVIATION 3.6 • n=93 Participants
|
14.3 units on a scale
STANDARD_DEVIATION 2.5 • n=4 Participants
|
15.8 units on a scale
STANDARD_DEVIATION 3.4 • n=27 Participants
|
|
Age, Continuous
|
29.9 years
STANDARD_DEVIATION 3.1 • n=93 Participants
|
42.9 years
STANDARD_DEVIATION 11.7 • n=4 Participants
|
37.3 years
STANDARD_DEVIATION 11.5 • n=27 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
11 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
14 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
14 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
MADRS
|
31.4 units on a scale
STANDARD_DEVIATION 5.3 • n=93 Participants
|
26.9 units on a scale
STANDARD_DEVIATION 4.4 • n=4 Participants
|
28.9 units on a scale
STANDARD_DEVIATION 5.2 • n=27 Participants
|
|
CGI-S
|
4.7 units on a scale
STANDARD_DEVIATION 0.8 • n=93 Participants
|
4.4 units on a scale
STANDARD_DEVIATION 0.5 • n=4 Participants
|
4.6 units on a scale
STANDARD_DEVIATION 0.6 • n=27 Participants
|
PRIMARY outcome
Timeframe: 24 hours after start of infusionThis is a 10-item instrument used for the evaluation of depressive symptoms in adults and for the assessment of any changes to those symptoms. Each of the 10 items is rated on a scale of 0 to 6, with differing descriptors for each item. These individual item scores are added together to form a total score, which can range between 0 (normal) and 60 (severe depression).
Outcome measures
| Measure |
Placebo and Ketamine
n=7 Participants
Placebo saline given over 240 minutes + 0.5 mg/kg ketamine given over the last 40 minutes of the infusion
|
Nitroprusside and Ketamine
n=9 Participants
0.5 mcg/kg/min nitroprusside given over 240 min (4 hours) - 0.5 mg/kg ketamine given over the last 40 min of the nitroprusside infusion (starting at minute 200 the two drugs are given together)
|
|---|---|---|
|
Montgomery-Asberg Depression Rating Scale
|
13.4 score on a scale
Standard Deviation 11.9
|
14.2 score on a scale
Standard Deviation 10.2
|
SECONDARY outcome
Timeframe: 240 minutes after start of infusionThis is used to measure dissociative effects during the infusions. The scale includes 23 clinician administered items scored from 0 (not at all) to 4 (extremely). The CADSS measures impairment in body perception, environmental perception, time perception, memory impairment, and feelings of unreality. Full scale from 0-92, with lower score indicating better health outcomes.
Outcome measures
| Measure |
Placebo and Ketamine
n=7 Participants
Placebo saline given over 240 minutes + 0.5 mg/kg ketamine given over the last 40 minutes of the infusion
|
Nitroprusside and Ketamine
n=9 Participants
0.5 mcg/kg/min nitroprusside given over 240 min (4 hours) - 0.5 mg/kg ketamine given over the last 40 min of the nitroprusside infusion (starting at minute 200 the two drugs are given together)
|
|---|---|---|
|
Clinician-Administered Dissociative States Scale
|
11.5 score on a scale
Standard Deviation 9.9
|
8.4 score on a scale
Standard Deviation 4.1
|
SECONDARY outcome
Timeframe: 240 minutes after start of infusionPopulation: data not collected
These scales are scored in millimeters from the left-hand side of a 100-mm line to a perpendicular mark made by the patient at a point corresponding to the apparent magnitude of the feeling state. Range: 0 ("not at all") to 100 ("most ever").
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: +240 minutes (after start of Placebo/Nitroprusside infusion)BPRS used to assess acute behavioral changes during the infusions. Four key BPRS items for the positive (+) symptoms of psychosis will be used: conceptual disorganization, hallucinatory behavior, suspiciousness, and unusual thought content. Three items representing the negative (-) symptoms of psychosis will also be used: blunted affect, emotional withdrawal, and motor retardation. Each item scored 1-7. Full scale from 7 - 49, with higher score indicating more symptoms.
Outcome measures
| Measure |
Placebo and Ketamine
n=7 Participants
Placebo saline given over 240 minutes + 0.5 mg/kg ketamine given over the last 40 minutes of the infusion
|
Nitroprusside and Ketamine
n=9 Participants
0.5 mcg/kg/min nitroprusside given over 240 min (4 hours) - 0.5 mg/kg ketamine given over the last 40 min of the nitroprusside infusion (starting at minute 200 the two drugs are given together)
|
|---|---|---|
|
Brief Psychiatric Rating Scale (BPRS)
|
7.5 score on a scale
Standard Deviation 1.13
|
7.2 score on a scale
Standard Deviation 0.66
|
Adverse Events
Placebo and Ketamine
Nitroprusside and Ketamine
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo and Ketamine
n=7 participants at risk
Placebo saline given over 240 minutes + 0.5 mg/kg ketamine given over the last 40 minutes of the infusion
|
Nitroprusside and Ketamine
n=9 participants at risk
0.5 mcg/kg/min nitroprusside given over 240 min (4 hours) - 0.5 mg/kg ketamine given over the last 40 min of the nitroprusside infusion (starting at minute 200 the two drugs are given together)
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
14.3%
1/7 • 24 hours after infusion
|
22.2%
2/9 • 24 hours after infusion
|
|
Nervous system disorders
Headache
|
28.6%
2/7 • 24 hours after infusion
|
33.3%
3/9 • 24 hours after infusion
|
|
Nervous system disorders
Dizziness
|
28.6%
2/7 • 24 hours after infusion
|
0.00%
0/9 • 24 hours after infusion
|
|
Nervous system disorders
Paresthesia
|
14.3%
1/7 • 24 hours after infusion
|
0.00%
0/9 • 24 hours after infusion
|
|
Nervous system disorders
Akathisia
|
0.00%
0/7 • 24 hours after infusion
|
11.1%
1/9 • 24 hours after infusion
|
|
Musculoskeletal and connective tissue disorders
Muscle Aches
|
14.3%
1/7 • 24 hours after infusion
|
0.00%
0/9 • 24 hours after infusion
|
|
Renal and urinary disorders
Urinary Tract Infection
|
14.3%
1/7 • 24 hours after infusion
|
0.00%
0/9 • 24 hours after infusion
|
|
Psychiatric disorders
Anxiety
|
14.3%
1/7 • 24 hours after infusion
|
0.00%
0/9 • 24 hours after infusion
|
|
Psychiatric disorders
Suicidal Ideation
|
14.3%
1/7 • 24 hours after infusion
|
0.00%
0/9 • 24 hours after infusion
|
|
Psychiatric disorders
Worsening MDD
|
0.00%
0/7 • 24 hours after infusion
|
11.1%
1/9 • 24 hours after infusion
|
|
Cardiac disorders
Hypertension
|
0.00%
0/7 • 24 hours after infusion
|
11.1%
1/9 • 24 hours after infusion
|
Additional Information
Dr. James Murrough
Icahn School of Medicine at Mount Sinai
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place