Trial Outcomes & Findings for Trial of the Rapid Antisuicidal Effects of Intranasal Ketamine in Comorbid Depression and Alcohol Abuse (NCT NCT03539887)
NCT ID: NCT03539887
Last Updated: 2023-03-01
Results Overview
The scale contains 19 items rated on a scale from 0 to 2, allowing score range from 0 to 38, score over 4 (first five items) will be considered inclusion criteria. Higher values indicate worsening or presence of suicidal ideation.
COMPLETED
PHASE3
33 participants
24 hours
2023-03-01
Participant Flow
5 participants who were enrolled were not randomized and did not start the study.
Participant milestones
| Measure |
Intranasal Ketamine
Intranasal ketamine
Intranasal ketamine: Intranasal ketamine will be prepared as 100mg/ml ketamine in 0.9% saline. An mucosal atomization device will be used to provide 5 intranasal applications of solution (volume 100 μl), separated by 3 minutes, over a total of 15 minutes. Each of five ketamine applications will provide 10 mg of study drug, for a total of 50mg. The dose to be used (0.5-1mg/Kg) is 6 to 18 times lower than the sedation dose (6-9mg/Kg).
|
Placebo
non-active placebo
Placebo: Saline alone. An mucosal atomization device will be used to provide 5 intranasal applications of saline (volume 100 μl), separated by 3 minutes, over a total of 15 minutes.
|
|---|---|---|
|
Overall Study
STARTED
|
17
|
11
|
|
Overall Study
COMPLETED
|
17
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Trial of the Rapid Antisuicidal Effects of Intranasal Ketamine in Comorbid Depression and Alcohol Abuse
Baseline characteristics by cohort
| Measure |
Intranasal Ketamine
n=17 Participants
Intranasal ketamine
Intranasal ketamine: Intranasal ketamine will be prepared as 100mg/ml ketamine in 0.9% saline. An mucosal atomization device will be used to provide 5 intranasal applications of solution (volume 100 μl), separated by 3 minutes, over a total of 15 minutes. Each of five ketamine applications will provide 10 mg of study drug, for a total of 50mg. The dose to be used (0.5-1mg/Kg) is 6 to 18 times lower than the sedation dose (6-9mg/Kg).
|
Placebo
n=11 Participants
non-active placebo
Placebo: Saline alone. An mucosal atomization device will be used to provide 5 intranasal applications of saline (volume 100 μl), separated by 3 minutes, over a total of 15 minutes.
|
Total
n=28 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
39 years
STANDARD_DEVIATION 9 • n=99 Participants
|
38.5 years
STANDARD_DEVIATION 13.8 • n=107 Participants
|
38.8 years
STANDARD_DEVIATION 11.1 • n=206 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
17 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
28 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 24 hoursPopulation: Data for this outcome measure were not collected for 1 participant in the placebo arm.
The scale contains 19 items rated on a scale from 0 to 2, allowing score range from 0 to 38, score over 4 (first five items) will be considered inclusion criteria. Higher values indicate worsening or presence of suicidal ideation.
Outcome measures
| Measure |
Placebo
n=10 Participants
non-active placebo
Placebo: Saline alone. An mucosal atomization device will be used to provide 5 intranasal applications of saline (volume 100 μl), separated by 3 minutes, over a total of 15 minutes.
|
Intranasal Ketamine
n=17 Participants
Intranasal ketamine
Intranasal ketamine: Intranasal ketamine will be prepared as 100mg/ml ketamine in 0.9% saline. An mucosal atomization device will be used to provide 5 intranasal applications of solution (volume 100 μl), separated by 3 minutes, over a total of 15 minutes. Each of five ketamine applications will provide 10 mg of study drug, for a total of 50mg. The dose to be used (0.5-1mg/Kg) is 6 to 18 times lower than the sedation dose (6-9mg/Kg).
|
|---|---|---|
|
Suicidal Ideation as Assessed by the Scale for Suicide Ideation (SSI)
|
12.3 score on a scale
Standard Deviation 7.83
|
10.8 score on a scale
Standard Deviation 8.08
|
SECONDARY outcome
Timeframe: 24 hoursPopulation: Data for this outcome measure were not collected for 1 participant in the placebo arm.
It has ten items, each item yields a score of 0 to 6. Hence the overall score ranges from 0 to 60. Higher scores indicate more severe depression.
Outcome measures
| Measure |
Placebo
n=10 Participants
non-active placebo
Placebo: Saline alone. An mucosal atomization device will be used to provide 5 intranasal applications of saline (volume 100 μl), separated by 3 minutes, over a total of 15 minutes.
|
Intranasal Ketamine
n=17 Participants
Intranasal ketamine
Intranasal ketamine: Intranasal ketamine will be prepared as 100mg/ml ketamine in 0.9% saline. An mucosal atomization device will be used to provide 5 intranasal applications of solution (volume 100 μl), separated by 3 minutes, over a total of 15 minutes. Each of five ketamine applications will provide 10 mg of study drug, for a total of 50mg. The dose to be used (0.5-1mg/Kg) is 6 to 18 times lower than the sedation dose (6-9mg/Kg).
|
|---|---|---|
|
Depression as Assessed by the Montgomery-Åsberg Depression Rating Scale (MADRS)
|
22.5 score on a scale
Standard Deviation 17.7
|
16.8 score on a scale
Standard Deviation 13.7
|
SECONDARY outcome
Timeframe: 24 hoursPopulation: Data for this outcome measure were not collected for 1 participant in the placebo arm.
The Snaith-Hamilton Pleasure Scale (SHAPS) is an assessment of anhedonia, which is the inability to experience pleasure. The SHAPS has 14 items. Each item has four possible responses: strongly disagree, disagree, agree, or strongly agree. A response of "strongly disagree" or "disagree" equals one point, and a response of "strongly agree" or "agree" equals 0 points. Thus, the final score ranges from 0 to 14. A score of 2 or less constitutes a "normal" score, while an "abnormal" score is defined as 3 or more.
Outcome measures
| Measure |
Placebo
n=10 Participants
non-active placebo
Placebo: Saline alone. An mucosal atomization device will be used to provide 5 intranasal applications of saline (volume 100 μl), separated by 3 minutes, over a total of 15 minutes.
|
Intranasal Ketamine
n=17 Participants
Intranasal ketamine
Intranasal ketamine: Intranasal ketamine will be prepared as 100mg/ml ketamine in 0.9% saline. An mucosal atomization device will be used to provide 5 intranasal applications of solution (volume 100 μl), separated by 3 minutes, over a total of 15 minutes. Each of five ketamine applications will provide 10 mg of study drug, for a total of 50mg. The dose to be used (0.5-1mg/Kg) is 6 to 18 times lower than the sedation dose (6-9mg/Kg).
|
|---|---|---|
|
Snaith-Hamilton Pleasure Scale
|
5.00 score on a scale
Standard Deviation 4.29
|
4.12 score on a scale
Standard Deviation 4.81
|
SECONDARY outcome
Timeframe: 24 hoursPopulation: Data for this outcome measure were not collected for 1 participant in the ketamine arm and one participant in the placebo arm.
Alcohol Urge Questionnaire (AUQ) is a multi-item measure of self-reported urges to drink alcohol, predictor of drinking abuse and relapse. AUQ is an 8-item questionnaire. Each item is scored on a 1 to 7 scale (Strongly Disagree = 1 and Strongly Agree = 7). Items 2 and 7 are reverse scored. Total score ranges from 8 to 56, and a higher score reflects greater craving.
Outcome measures
| Measure |
Placebo
n=10 Participants
non-active placebo
Placebo: Saline alone. An mucosal atomization device will be used to provide 5 intranasal applications of saline (volume 100 μl), separated by 3 minutes, over a total of 15 minutes.
|
Intranasal Ketamine
n=16 Participants
Intranasal ketamine
Intranasal ketamine: Intranasal ketamine will be prepared as 100mg/ml ketamine in 0.9% saline. An mucosal atomization device will be used to provide 5 intranasal applications of solution (volume 100 μl), separated by 3 minutes, over a total of 15 minutes. Each of five ketamine applications will provide 10 mg of study drug, for a total of 50mg. The dose to be used (0.5-1mg/Kg) is 6 to 18 times lower than the sedation dose (6-9mg/Kg).
|
|---|---|---|
|
Alcohol Urge Questionnaire (AUQ)
|
16.3 score on a scale
Standard Deviation 11.2
|
13.8 score on a scale
Standard Deviation 12.2
|
SECONDARY outcome
Timeframe: 24 hoursPopulation: Data for this outcome measure were not collected for 1 participant in the placebo arm
The YMRS has 11 items, and total score ranges from 0 to 88, with a higher score indicating greater mania.
Outcome measures
| Measure |
Placebo
n=10 Participants
non-active placebo
Placebo: Saline alone. An mucosal atomization device will be used to provide 5 intranasal applications of saline (volume 100 μl), separated by 3 minutes, over a total of 15 minutes.
|
Intranasal Ketamine
n=17 Participants
Intranasal ketamine
Intranasal ketamine: Intranasal ketamine will be prepared as 100mg/ml ketamine in 0.9% saline. An mucosal atomization device will be used to provide 5 intranasal applications of solution (volume 100 μl), separated by 3 minutes, over a total of 15 minutes. Each of five ketamine applications will provide 10 mg of study drug, for a total of 50mg. The dose to be used (0.5-1mg/Kg) is 6 to 18 times lower than the sedation dose (6-9mg/Kg).
|
|---|---|---|
|
Manic Symptoms as Assessed by Score on the Young Mania Rating Scale (YMRS)
|
2.40 score on a scale
Standard Deviation 2.12
|
2.29 score on a scale
Standard Deviation 2.85
|
SECONDARY outcome
Timeframe: 24 hoursPopulation: Data for this outcome measure were not collected for 1 participant in the placebo arm.
The CADSS consists of 23 items, and each item is rated on a scale from 0 (not at all) to 4 (severe), with the total score ranging from 0 to 92. A higher score indicates greater severity of dissociative state.
Outcome measures
| Measure |
Placebo
n=10 Participants
non-active placebo
Placebo: Saline alone. An mucosal atomization device will be used to provide 5 intranasal applications of saline (volume 100 μl), separated by 3 minutes, over a total of 15 minutes.
|
Intranasal Ketamine
n=17 Participants
Intranasal ketamine
Intranasal ketamine: Intranasal ketamine will be prepared as 100mg/ml ketamine in 0.9% saline. An mucosal atomization device will be used to provide 5 intranasal applications of solution (volume 100 μl), separated by 3 minutes, over a total of 15 minutes. Each of five ketamine applications will provide 10 mg of study drug, for a total of 50mg. The dose to be used (0.5-1mg/Kg) is 6 to 18 times lower than the sedation dose (6-9mg/Kg).
|
|---|---|---|
|
Dissociative State as Assessed by Score on Clinician-Administered Dissociative States Scale (CADSS)
|
1.60 score on a scale
Standard Deviation 3.20
|
0.824 score on a scale
Standard Deviation 2.90
|
Adverse Events
Intranasal Ketamine
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Intranasal Ketamine
n=17 participants at risk
Intranasal ketamine
Intranasal ketamine: Intranasal ketamine will be prepared as 100mg/ml ketamine in 0.9% saline. An mucosal atomization device will be used to provide 5 intranasal applications of solution (volume 100 μl), separated by 3 minutes, over a total of 15 minutes. Each of five ketamine applications will provide 10 mg of study drug, for a total of 50mg. The dose to be used (0.5-1mg/Kg) is 6 to 18 times lower than the sedation dose (6-9mg/Kg).
|
Placebo
n=11 participants at risk
non-active placebo
Placebo: Saline alone. An mucosal atomization device will be used to provide 5 intranasal applications of saline (volume 100 μl), separated by 3 minutes, over a total of 15 minutes.
|
|---|---|---|
|
Nervous system disorders
Cognitive side effect
|
70.6%
12/17 • Number of events 12 • 48 hours
|
36.4%
4/11 • Number of events 4 • 48 hours
|
Additional Information
Rodrigo Machado-Vieira, MD, PhD, MSc
The University of Texas Health Science Center at Houston
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place