Trial Outcomes & Findings for miRNAs, Suicide, and Ketamine - Plasma Exosomal microRNAs as Novel Biomarkers for Suicidality and Treatment Outcome (NCT NCT02418195)
NCT ID: NCT02418195
Last Updated: 2022-08-30
Results Overview
The Beck Scale for Suicidal Ideation (BSSI) is a 21-item, self-report rating scale that measures the current intensity of specific attitudes, behaviors, and plans to commit suicide. Each item consists of 3 options graded according to intensity on a 3-point scale (0-2). Scores range from 0-42, with higher scores indicating more severe symptoms. The participant numbers below correlate to the number of usable lab samples. This is the reason for discrepancy in numbers.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
247 participants
Primary outcome timeframe
180 minutes post dose
Results posted on
2022-08-30
Participant Flow
Participants were enrolled April 2015 through December 2020. The last subject completed their final visit on December 30, 2020. Participants were enrolled through advertising means, such as flyers, physician referrals, sub-I clinic referrals, and chart review, via Impact. As of May 2022, study is in data analysis. Final outcomes will be known once analysis is complete.
A number of participants were excluded for not meeting inclusion or meeting exclusion criteria, in total 51. These were considered screen failures.
Participant milestones
| Measure |
MDD With Recent Suicide Attempt
All subjects with Major Depressive Disorder with a recent Suicide Attempt (in the past 2 weeks) will receive a one-time IV infusion of ketamine at a dose of 0.5mg/kg at a rate of 40 milliliters (mL) over 40 minutes. Blood will be drawn at pre-dose, 30 minutes post dose, 180 minutes post dose, 24 hours post dose, and 14 days post dose to measure changes in miRNAs.
ketamine: IV infusion of ketamine 0.5mg/kg at a rate of 40mL over 40 minutes
|
MDD With Suicidal Ideation no Attempt
All subjects with Major Depressive Disorder with recent Suicidal Ideation (in the past 7 days) without a recent Suicide Attempt (in the past 6 months) will receive a one-time IV infusion of ketamine at a dose of 0.5mg/kg at a rate of 40mL over 40 minutes. Blood will be drawn at pre-dose, 30 minutes post dose, 180 minutes post dose, 24 hours post dose, and 14 days post dose to measure changes in miRNAs.
ketamine: IV infusion of ketamine 0.5mg/kg at a rate of 40mL over 40 minutes
|
MDD Without Suicidal Ideation no Attempt
All subjects with Major Depressive Disorder without recent Suicidal Ideation (in the past 7 days) without a recent Suicide Attempt (in the past 6 months) will receive a one-time IV infusion of ketamine at a dose of 0.5mg/kg at a rate of 40mL over 40 minutes. Blood will be drawn at pre-dose, 30 minutes post dose, 180 minutes post dose, 24 hours post dose, and 14 days post dose to measure changes in miRNAs.
ketamine: IV infusion of ketamine 0.5mg/kg at a rate of 40mL over 40 minutes
|
Healthy Controls
Healthy Control subjects without a psychiatric diagnosis will have a one-time blood draw to examine miRNAs.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
62
|
63
|
61
|
61
|
|
Overall Study
COMPLETED
|
62
|
63
|
61
|
61
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
miRNAs, Suicide, and Ketamine - Plasma Exosomal microRNAs as Novel Biomarkers for Suicidality and Treatment Outcome
Baseline characteristics by cohort
| Measure |
MDD With Recent Suicide Attempt
n=62 Participants
All subjects with Major Depressive Disorder with a recent Suicide Attempt (in the past 2 weeks) will receive a one-time IV infusion of ketamine at a dose of 0.5mg/kg at a rate of 40mL over 40 minutes. Blood will be drawn at pre-dose, 30 minutes post dose, 180 minutes post dose, 24 hours post dose, and 14 days post dose to measure changes in miRNAs.
ketamine: IV infusion of ketamine 0.5mg/kg at a rate of 40mL over 40 minutes
|
MDD With Suicidal Ideation no Attempt
n=63 Participants
All subjects with Major Depressive Disorder with recent Suicidal Ideation (in the past 7 days) without a recent Suicide Attempt (in the past 6 months) will receive a one-time IV infusion of ketamine at a dose of 0.5mg/kg at a rate of 40mL over 40 minutes. Blood will be drawn at pre-dose, 30 minutes post dose, 180 minutes post dose, 24 hours post dose, and 14 days post dose to measure changes in miRNAs.
ketamine: IV infusion of ketamine 0.5mg/kg at a rate of 40mL over 40 minutes
|
MDD Without Suicidal Ideation no Attempt
n=61 Participants
All subjects with Major Depressive Disorder without recent Suicidal Ideation (in the past 7 days) without a recent Suicide Attempt (in the past 6 months) will receive a one-time IV infusion of ketamine at a dose of 0.5mg/kg at a rate of 40mL over 40 minutes. Blood will be drawn at pre-dose, 30 minutes post dose, 180 minutes post dose, 24 hours post dose, and 14 days post dose to measure changes in miRNAs.
ketamine: IV infusion of ketamine 0.5mg/kg at a rate of 40mL over 40 minutes
|
Healthy Controls
n=61 Participants
Healthy Control subjects without a psychiatric diagnosis will have a one-time blood draw to examine miRNAs.
|
Total
n=247 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
62 Participants
n=5 Participants
|
63 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
61 Participants
n=4 Participants
|
247 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Continuous
|
35.53 years
STANDARD_DEVIATION 11.70 • n=5 Participants
|
39.94 years
STANDARD_DEVIATION 14.05 • n=7 Participants
|
44.62 years
STANDARD_DEVIATION 12.26 • n=5 Participants
|
37.54 years
STANDARD_DEVIATION 12.65 • n=4 Participants
|
39.40 years
STANDARD_DEVIATION 13.07 • n=21 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
35 Participants
n=4 Participants
|
150 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
97 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
60 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
60 Participants
n=4 Participants
|
241 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
13 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
47 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
46 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
45 Participants
n=4 Participants
|
192 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
62 participants
n=5 Participants
|
63 participants
n=7 Participants
|
61 participants
n=5 Participants
|
61 participants
n=4 Participants
|
247 participants
n=21 Participants
|
|
Number enrolled
|
62 Participants
n=5 Participants
|
63 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
61 Participants
n=4 Participants
|
247 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 180 minutes post doseThe Beck Scale for Suicidal Ideation (BSSI) is a 21-item, self-report rating scale that measures the current intensity of specific attitudes, behaviors, and plans to commit suicide. Each item consists of 3 options graded according to intensity on a 3-point scale (0-2). Scores range from 0-42, with higher scores indicating more severe symptoms. The participant numbers below correlate to the number of usable lab samples. This is the reason for discrepancy in numbers.
Outcome measures
| Measure |
MDD With Recent Suicide Attempt
n=56 Participants
All subjects with Major Depressive Disorder with a recent Suicide Attempt (in the past 2 weeks) will receive a one-time IV infusion of ketamine at a dose of 0.5mg/kg at a rate of 40mL over 40 minutes. Blood will be drawn at pre-dose, 30 minutes post dose, 180 minutes post dose, 24 hours post dose, and 14 days post dose to measure changes in miRNAs.
ketamine: IV infusion of ketamine 0.5mg/kg at a rate of 40mL over 40 minutes
|
MDD With Suicidal Ideation no Attempt
n=56 Participants
All subjects with Major Depressive Disorder with recent Suicidal Ideation (in the past 7 days) without a recent Suicide Attempt (in the past 6 months) will receive a one-time IV infusion of ketamine at a dose of 0.5mg/kg at a rate of 40mL over 40 minutes. Blood will be drawn at pre-dose, 30 minutes post dose, 180 minutes post dose, 24 hours post dose, and 14 days post dose to measure changes in miRNAs.
ketamine: IV infusion of ketamine 0.5mg/kg at a rate of 40mL over 40 minutes
|
MDD Without Suicidal Ideation no Attempt
n=60 Participants
All subjects with Major Depressive Disorder without recent Suicidal Ideation (in the past 7 days) without a recent Suicide Attempt (in the past 6 months) will receive a one-time IV infusion of ketamine at a dose of 0.5mg/kg at a rate of 40mL over 40 minutes. Blood will be drawn at pre-dose, 30 minutes post dose, 180 minutes post dose, 24 hours post dose, and 14 days post dose to measure changes in miRNAs.
ketamine: IV infusion of ketamine 0.5mg/kg at a rate of 40mL over 40 minutes
|
|---|---|---|---|
|
Beck Scale for Suicide Ideation (BSS)
|
9.09 units on a scale
Standard Deviation 9.843
|
8.46 units on a scale
Standard Deviation 8.954
|
1.9 units on a scale
Standard Deviation 3.551
|
SECONDARY outcome
Timeframe: 180 minutes post doseThe Montgomery-Åsberg Depression Rating Scale revised to reflect shorter timeframes will be the primary measure of change in depression. The Montgomery-Asberg Depression Rating Scale is a ten-item diagnostic questionnaire which psychiatrists use to measure the severity of depressive episodes in patients with mood disorders. A total score ranging from 0 to 6 indicates that the patient is in the normal range (no depression), a score ranging from 7 to 19 indicates mild depression, 20 to 34 indicates moderate depression, a score of 35 and greater indicates severe depression, and a total score of 60 indicates very severe depression. Scores range form 0-60, with higher scores indicating more severe symptoms. The participant numbers below correlate to the number of usable lab samples. This is the reason for discrepancy in numbers
Outcome measures
| Measure |
MDD With Recent Suicide Attempt
n=56 Participants
All subjects with Major Depressive Disorder with a recent Suicide Attempt (in the past 2 weeks) will receive a one-time IV infusion of ketamine at a dose of 0.5mg/kg at a rate of 40mL over 40 minutes. Blood will be drawn at pre-dose, 30 minutes post dose, 180 minutes post dose, 24 hours post dose, and 14 days post dose to measure changes in miRNAs.
ketamine: IV infusion of ketamine 0.5mg/kg at a rate of 40mL over 40 minutes
|
MDD With Suicidal Ideation no Attempt
n=56 Participants
All subjects with Major Depressive Disorder with recent Suicidal Ideation (in the past 7 days) without a recent Suicide Attempt (in the past 6 months) will receive a one-time IV infusion of ketamine at a dose of 0.5mg/kg at a rate of 40mL over 40 minutes. Blood will be drawn at pre-dose, 30 minutes post dose, 180 minutes post dose, 24 hours post dose, and 14 days post dose to measure changes in miRNAs.
ketamine: IV infusion of ketamine 0.5mg/kg at a rate of 40mL over 40 minutes
|
MDD Without Suicidal Ideation no Attempt
n=60 Participants
All subjects with Major Depressive Disorder without recent Suicidal Ideation (in the past 7 days) without a recent Suicide Attempt (in the past 6 months) will receive a one-time IV infusion of ketamine at a dose of 0.5mg/kg at a rate of 40mL over 40 minutes. Blood will be drawn at pre-dose, 30 minutes post dose, 180 minutes post dose, 24 hours post dose, and 14 days post dose to measure changes in miRNAs.
ketamine: IV infusion of ketamine 0.5mg/kg at a rate of 40mL over 40 minutes
|
|---|---|---|---|
|
Montgomery Asberg Depression Rating Scale (MADRS)
|
11.7 units on a scale
Standard Deviation 10.582
|
11.56 units on a scale
Standard Deviation 8.981
|
8.14 units on a scale
Standard Deviation 5.338
|
SECONDARY outcome
Timeframe: 180 minutes post doseThe Beck Depression Inventory is a 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression. The inventory contains 21 items on a 4-point scale from 0 (symptom absent) to 3 (severe symptoms). Anxiety symptoms are not assessed but affective, cognitive, somatic and vegetative symptoms are covered. Scoring is achieved by adding the highest ratings for all 21 items. The minimum score is 0 and maximum score is 63. Higher scores indicate greater symptom severity. The participant numbers below correlate to the number of usable lab samples. This is the reason for discrepancy in numbers.
Outcome measures
| Measure |
MDD With Recent Suicide Attempt
n=56 Participants
All subjects with Major Depressive Disorder with a recent Suicide Attempt (in the past 2 weeks) will receive a one-time IV infusion of ketamine at a dose of 0.5mg/kg at a rate of 40mL over 40 minutes. Blood will be drawn at pre-dose, 30 minutes post dose, 180 minutes post dose, 24 hours post dose, and 14 days post dose to measure changes in miRNAs.
ketamine: IV infusion of ketamine 0.5mg/kg at a rate of 40mL over 40 minutes
|
MDD With Suicidal Ideation no Attempt
n=56 Participants
All subjects with Major Depressive Disorder with recent Suicidal Ideation (in the past 7 days) without a recent Suicide Attempt (in the past 6 months) will receive a one-time IV infusion of ketamine at a dose of 0.5mg/kg at a rate of 40mL over 40 minutes. Blood will be drawn at pre-dose, 30 minutes post dose, 180 minutes post dose, 24 hours post dose, and 14 days post dose to measure changes in miRNAs.
ketamine: IV infusion of ketamine 0.5mg/kg at a rate of 40mL over 40 minutes
|
MDD Without Suicidal Ideation no Attempt
n=60 Participants
All subjects with Major Depressive Disorder without recent Suicidal Ideation (in the past 7 days) without a recent Suicide Attempt (in the past 6 months) will receive a one-time IV infusion of ketamine at a dose of 0.5mg/kg at a rate of 40mL over 40 minutes. Blood will be drawn at pre-dose, 30 minutes post dose, 180 minutes post dose, 24 hours post dose, and 14 days post dose to measure changes in miRNAs.
ketamine: IV infusion of ketamine 0.5mg/kg at a rate of 40mL over 40 minutes
|
|---|---|---|---|
|
Beck Depression Inventory (BDI)
|
18.02 units on a scale
Standard Deviation 17.466
|
15.85 units on a scale
Standard Deviation 14.641
|
12.12 units on a scale
Standard Deviation 10.738
|
SECONDARY outcome
Timeframe: 180 minutes post doseThe scale is a 21-item self-report of anxiety. The total score is calculated by finding the sum of the 21 items. The scores range form 0-63, with higher scores indicating more severe symptoms. Score of 0 - 21 = low anxiety Score of 22 - 35 = moderate anxiety Score of 36 and above = potentially concerning levels of anxiety
Outcome measures
| Measure |
MDD With Recent Suicide Attempt
n=46 Participants
All subjects with Major Depressive Disorder with a recent Suicide Attempt (in the past 2 weeks) will receive a one-time IV infusion of ketamine at a dose of 0.5mg/kg at a rate of 40mL over 40 minutes. Blood will be drawn at pre-dose, 30 minutes post dose, 180 minutes post dose, 24 hours post dose, and 14 days post dose to measure changes in miRNAs.
ketamine: IV infusion of ketamine 0.5mg/kg at a rate of 40mL over 40 minutes
|
MDD With Suicidal Ideation no Attempt
n=54 Participants
All subjects with Major Depressive Disorder with recent Suicidal Ideation (in the past 7 days) without a recent Suicide Attempt (in the past 6 months) will receive a one-time IV infusion of ketamine at a dose of 0.5mg/kg at a rate of 40mL over 40 minutes. Blood will be drawn at pre-dose, 30 minutes post dose, 180 minutes post dose, 24 hours post dose, and 14 days post dose to measure changes in miRNAs.
ketamine: IV infusion of ketamine 0.5mg/kg at a rate of 40mL over 40 minutes
|
MDD Without Suicidal Ideation no Attempt
n=59 Participants
All subjects with Major Depressive Disorder without recent Suicidal Ideation (in the past 7 days) without a recent Suicide Attempt (in the past 6 months) will receive a one-time IV infusion of ketamine at a dose of 0.5mg/kg at a rate of 40mL over 40 minutes. Blood will be drawn at pre-dose, 30 minutes post dose, 180 minutes post dose, 24 hours post dose, and 14 days post dose to measure changes in miRNAs.
ketamine: IV infusion of ketamine 0.5mg/kg at a rate of 40mL over 40 minutes
|
|---|---|---|---|
|
Beck Anxiety Inventory (BAI)
|
6.76 units on a scale
Standard Deviation 10.025
|
6.59 units on a scale
Standard Deviation 11.190
|
3.31 units on a scale
Standard Deviation 5.240
|
SECONDARY outcome
Timeframe: 180 minutes post doseThe Beck Hopelessness Scale is a 20-item self-report index of pessimism about the future, loss of motivation, and negative expectations. Each optimistic response is scored as 0 and each pessimistic response is scored as 1. A total score is calculated by summing the pessimistic responses for each of the 20 items. Minimum possible score is 0. The participant numbers below correlate to the number of usable lab samples. This is the reason for discrepancy in numbers.
Outcome measures
| Measure |
MDD With Recent Suicide Attempt
n=56 Participants
All subjects with Major Depressive Disorder with a recent Suicide Attempt (in the past 2 weeks) will receive a one-time IV infusion of ketamine at a dose of 0.5mg/kg at a rate of 40mL over 40 minutes. Blood will be drawn at pre-dose, 30 minutes post dose, 180 minutes post dose, 24 hours post dose, and 14 days post dose to measure changes in miRNAs.
ketamine: IV infusion of ketamine 0.5mg/kg at a rate of 40mL over 40 minutes
|
MDD With Suicidal Ideation no Attempt
n=56 Participants
All subjects with Major Depressive Disorder with recent Suicidal Ideation (in the past 7 days) without a recent Suicide Attempt (in the past 6 months) will receive a one-time IV infusion of ketamine at a dose of 0.5mg/kg at a rate of 40mL over 40 minutes. Blood will be drawn at pre-dose, 30 minutes post dose, 180 minutes post dose, 24 hours post dose, and 14 days post dose to measure changes in miRNAs.
ketamine: IV infusion of ketamine 0.5mg/kg at a rate of 40mL over 40 minutes
|
MDD Without Suicidal Ideation no Attempt
n=60 Participants
All subjects with Major Depressive Disorder without recent Suicidal Ideation (in the past 7 days) without a recent Suicide Attempt (in the past 6 months) will receive a one-time IV infusion of ketamine at a dose of 0.5mg/kg at a rate of 40mL over 40 minutes. Blood will be drawn at pre-dose, 30 minutes post dose, 180 minutes post dose, 24 hours post dose, and 14 days post dose to measure changes in miRNAs.
ketamine: IV infusion of ketamine 0.5mg/kg at a rate of 40mL over 40 minutes
|
|---|---|---|---|
|
Beck Hopelessness Scale (BHS)
|
8.25 units on a scale
Standard Deviation 6.641
|
8.35 units on a scale
Standard Deviation 6.253
|
7.22 units on a scale
Standard Deviation 5.781
|
SECONDARY outcome
Timeframe: 180 minutes post doseThe Brief Psychiatric Rating Scale is used to assess the presence of psychotic symptoms. This 4-item version assesses conceptual disorganization, suspiciousness/persecution, hallucinatory behavior, and unusual thought content. Each item is rated on a scale from 0 (not present) to 6 (extreme). The scores range from 0-24, with higher scores indicating more severe symptoms. The participant numbers below correlate to the number of usable lab samples. This is the reason for discrepancy in numbers.
Outcome measures
| Measure |
MDD With Recent Suicide Attempt
n=56 Participants
All subjects with Major Depressive Disorder with a recent Suicide Attempt (in the past 2 weeks) will receive a one-time IV infusion of ketamine at a dose of 0.5mg/kg at a rate of 40mL over 40 minutes. Blood will be drawn at pre-dose, 30 minutes post dose, 180 minutes post dose, 24 hours post dose, and 14 days post dose to measure changes in miRNAs.
ketamine: IV infusion of ketamine 0.5mg/kg at a rate of 40mL over 40 minutes
|
MDD With Suicidal Ideation no Attempt
n=56 Participants
All subjects with Major Depressive Disorder with recent Suicidal Ideation (in the past 7 days) without a recent Suicide Attempt (in the past 6 months) will receive a one-time IV infusion of ketamine at a dose of 0.5mg/kg at a rate of 40mL over 40 minutes. Blood will be drawn at pre-dose, 30 minutes post dose, 180 minutes post dose, 24 hours post dose, and 14 days post dose to measure changes in miRNAs.
ketamine: IV infusion of ketamine 0.5mg/kg at a rate of 40mL over 40 minutes
|
MDD Without Suicidal Ideation no Attempt
n=60 Participants
All subjects with Major Depressive Disorder without recent Suicidal Ideation (in the past 7 days) without a recent Suicide Attempt (in the past 6 months) will receive a one-time IV infusion of ketamine at a dose of 0.5mg/kg at a rate of 40mL over 40 minutes. Blood will be drawn at pre-dose, 30 minutes post dose, 180 minutes post dose, 24 hours post dose, and 14 days post dose to measure changes in miRNAs.
ketamine: IV infusion of ketamine 0.5mg/kg at a rate of 40mL over 40 minutes
|
|---|---|---|---|
|
4-item Brief Psychiatric Rating Scale (BPRS)
|
0.02 units on a scale
Standard Deviation 0.151
|
0.04 units on a scale
Standard Deviation 0.272
|
0.03 units on a scale
Standard Deviation 0.26
|
SECONDARY outcome
Timeframe: 180 minutes post doseThe Clinician-Administered Dissociative States Scale, ascertains the presence or absence of dissociative symptoms. There are 23 clinician-administered items, each scored from 0 (not at all) to 4 (extreme). Scores range from 0-92, with higher scores indicating more severe symptoms. Items assess impairment in body sensation, perception of time and environment, memory impairment, and feelings of unreality. The participant numbers below correlate to the number of usable lab samples. This is the reason for discrepancy in numbers.
Outcome measures
| Measure |
MDD With Recent Suicide Attempt
n=56 Participants
All subjects with Major Depressive Disorder with a recent Suicide Attempt (in the past 2 weeks) will receive a one-time IV infusion of ketamine at a dose of 0.5mg/kg at a rate of 40mL over 40 minutes. Blood will be drawn at pre-dose, 30 minutes post dose, 180 minutes post dose, 24 hours post dose, and 14 days post dose to measure changes in miRNAs.
ketamine: IV infusion of ketamine 0.5mg/kg at a rate of 40mL over 40 minutes
|
MDD With Suicidal Ideation no Attempt
n=56 Participants
All subjects with Major Depressive Disorder with recent Suicidal Ideation (in the past 7 days) without a recent Suicide Attempt (in the past 6 months) will receive a one-time IV infusion of ketamine at a dose of 0.5mg/kg at a rate of 40mL over 40 minutes. Blood will be drawn at pre-dose, 30 minutes post dose, 180 minutes post dose, 24 hours post dose, and 14 days post dose to measure changes in miRNAs.
ketamine: IV infusion of ketamine 0.5mg/kg at a rate of 40mL over 40 minutes
|
MDD Without Suicidal Ideation no Attempt
n=60 Participants
All subjects with Major Depressive Disorder without recent Suicidal Ideation (in the past 7 days) without a recent Suicide Attempt (in the past 6 months) will receive a one-time IV infusion of ketamine at a dose of 0.5mg/kg at a rate of 40mL over 40 minutes. Blood will be drawn at pre-dose, 30 minutes post dose, 180 minutes post dose, 24 hours post dose, and 14 days post dose to measure changes in miRNAs.
ketamine: IV infusion of ketamine 0.5mg/kg at a rate of 40mL over 40 minutes
|
|---|---|---|---|
|
Clinician-Administered Dissociative States Scale (CADSS)
|
0.5 units on a scale
Standard Deviation 0.902
|
0.37 units on a scale
Standard Deviation 0.853
|
0.34 units on a scale
Standard Deviation 0.801
|
SECONDARY outcome
Timeframe: 180 minutes post doseThis scale assesses for manic symptoms. The scale has 11 items and is based on the patient's subjective report of his or her clinical condition over the previous 48 hours. 13-19=minimal symptoms; 20-25=mild mania, 26-37=moderate mania, 38-60=severe mania. The YMRS total score ranges from 0 to 60 where higher scores indicate more severe mania.
Outcome measures
| Measure |
MDD With Recent Suicide Attempt
n=46 Participants
All subjects with Major Depressive Disorder with a recent Suicide Attempt (in the past 2 weeks) will receive a one-time IV infusion of ketamine at a dose of 0.5mg/kg at a rate of 40mL over 40 minutes. Blood will be drawn at pre-dose, 30 minutes post dose, 180 minutes post dose, 24 hours post dose, and 14 days post dose to measure changes in miRNAs.
ketamine: IV infusion of ketamine 0.5mg/kg at a rate of 40mL over 40 minutes
|
MDD With Suicidal Ideation no Attempt
n=55 Participants
All subjects with Major Depressive Disorder with recent Suicidal Ideation (in the past 7 days) without a recent Suicide Attempt (in the past 6 months) will receive a one-time IV infusion of ketamine at a dose of 0.5mg/kg at a rate of 40mL over 40 minutes. Blood will be drawn at pre-dose, 30 minutes post dose, 180 minutes post dose, 24 hours post dose, and 14 days post dose to measure changes in miRNAs.
ketamine: IV infusion of ketamine 0.5mg/kg at a rate of 40mL over 40 minutes
|
MDD Without Suicidal Ideation no Attempt
n=59 Participants
All subjects with Major Depressive Disorder without recent Suicidal Ideation (in the past 7 days) without a recent Suicide Attempt (in the past 6 months) will receive a one-time IV infusion of ketamine at a dose of 0.5mg/kg at a rate of 40mL over 40 minutes. Blood will be drawn at pre-dose, 30 minutes post dose, 180 minutes post dose, 24 hours post dose, and 14 days post dose to measure changes in miRNAs.
ketamine: IV infusion of ketamine 0.5mg/kg at a rate of 40mL over 40 minutes
|
|---|---|---|---|
|
Young Mania Rating Scale (YMRS)
|
1.61 units on a scale
Standard Deviation 1.879
|
2.02 units on a scale
Standard Deviation 3.240
|
0.85 units on a scale
Standard Deviation 1.311
|
SECONDARY outcome
Timeframe: 180 minutes post doseThe Systematic Assessment for Treatment Emergent Events, is a 56 item, self-report inventory for adverse events. Each item is categorized by severity as: 0-none, 1-mild, 2-moderate, 3-severe. Score range is 0-168, with higher scores indicating more severe symptoms. It is designed to report adverse health events, regardless of whether or not they are suspected to be drug related, in order to reduce the under-reporting of unanticipated events compared with "known or expected" events. The participant numbers below correlate to the number of usable lab samples. This is the reason for discrepancy in numbers.
Outcome measures
| Measure |
MDD With Recent Suicide Attempt
n=56 Participants
All subjects with Major Depressive Disorder with a recent Suicide Attempt (in the past 2 weeks) will receive a one-time IV infusion of ketamine at a dose of 0.5mg/kg at a rate of 40mL over 40 minutes. Blood will be drawn at pre-dose, 30 minutes post dose, 180 minutes post dose, 24 hours post dose, and 14 days post dose to measure changes in miRNAs.
ketamine: IV infusion of ketamine 0.5mg/kg at a rate of 40mL over 40 minutes
|
MDD With Suicidal Ideation no Attempt
n=56 Participants
All subjects with Major Depressive Disorder with recent Suicidal Ideation (in the past 7 days) without a recent Suicide Attempt (in the past 6 months) will receive a one-time IV infusion of ketamine at a dose of 0.5mg/kg at a rate of 40mL over 40 minutes. Blood will be drawn at pre-dose, 30 minutes post dose, 180 minutes post dose, 24 hours post dose, and 14 days post dose to measure changes in miRNAs.
ketamine: IV infusion of ketamine 0.5mg/kg at a rate of 40mL over 40 minutes
|
MDD Without Suicidal Ideation no Attempt
n=60 Participants
All subjects with Major Depressive Disorder without recent Suicidal Ideation (in the past 7 days) without a recent Suicide Attempt (in the past 6 months) will receive a one-time IV infusion of ketamine at a dose of 0.5mg/kg at a rate of 40mL over 40 minutes. Blood will be drawn at pre-dose, 30 minutes post dose, 180 minutes post dose, 24 hours post dose, and 14 days post dose to measure changes in miRNAs.
ketamine: IV infusion of ketamine 0.5mg/kg at a rate of 40mL over 40 minutes
|
|---|---|---|---|
|
Systematic Assessment for Treatment Emergent Events (SAFTEE)
|
20.66 units on a scale
Standard Deviation 26.755
|
18.67 units on a scale
Standard Deviation 26.36
|
11.81 units on a scale
Standard Deviation 13.058
|
Adverse Events
MDD With Recent Suicide Attempt
Serious events: 5 serious events
Other events: 47 other events
Deaths: 0 deaths
MDD With Suicidal Ideation no Attempt
Serious events: 1 serious events
Other events: 58 other events
Deaths: 0 deaths
MDD Without Suicidal Ideation no Attempt
Serious events: 1 serious events
Other events: 60 other events
Deaths: 0 deaths
Healthy Controls
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
MDD With Recent Suicide Attempt
n=62 participants at risk
All subjects with Major Depressive Disorder with a recent Suicide Attempt (in the past 2 weeks) will receive a one-time IV infusion of ketamine at a dose of 0.5mg/kg at a rate of 40mL over 40 minutes. Blood will be drawn at pre-dose, 30 minutes post dose, 180 minutes post dose, 24 hours post dose, and 14 days post dose to measure changes in miRNAs.
ketamine: IV infusion of ketamine 0.5mg/kg at a rate of 40mL over 40 minutes
|
MDD With Suicidal Ideation no Attempt
n=63 participants at risk
All subjects with Major Depressive Disorder with recent Suicidal Ideation (in the past 7 days) without a recent Suicide Attempt (in the past 6 months) will receive a one-time IV infusion of ketamine at a dose of 0.5mg/kg at a rate of 40mL over 40 minutes. Blood will be drawn at pre-dose, 30 minutes post dose, 180 minutes post dose, 24 hours post dose, and 14 days post dose to measure changes in miRNAs.
ketamine: IV infusion of ketamine 0.5mg/kg at a rate of 40mL over 40 minutes
|
MDD Without Suicidal Ideation no Attempt
n=61 participants at risk
All subjects with Major Depressive Disorder without recent Suicidal Ideation (in the past 7 days) without a recent Suicide Attempt (in the past 6 months) will receive a one-time IV infusion of ketamine at a dose of 0.5mg/kg at a rate of 40mL over 40 minutes. Blood will be drawn at pre-dose, 30 minutes post dose, 180 minutes post dose, 24 hours post dose, and 14 days post dose to measure changes in miRNAs.
ketamine: IV infusion of ketamine 0.5mg/kg at a rate of 40mL over 40 minutes
|
Healthy Controls
n=61 participants at risk
Healthy Control subjects without a psychiatric diagnosis will have a one-time blood draw to examine miRNAs.
|
|---|---|---|---|---|
|
Cardiac disorders
elevated blood pressure
|
0.00%
0/62 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
0.00%
0/63 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
1.6%
1/61 • Number of events 1 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
0.00%
0/61 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
|
Psychiatric disorders
worsening depression and SI
|
1.6%
1/62 • Number of events 1 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
0.00%
0/63 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
0.00%
0/61 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
0.00%
0/61 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
|
Psychiatric disorders
suicide attempt
|
1.6%
1/62 • Number of events 1 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
0.00%
0/63 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
0.00%
0/61 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
0.00%
0/61 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
|
Psychiatric disorders
altered mental status
|
1.6%
1/62 • Number of events 1 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
0.00%
0/63 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
0.00%
0/61 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
0.00%
0/61 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
|
Psychiatric disorders
acute worsening depression
|
1.6%
1/62 • Number of events 1 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
0.00%
0/63 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
0.00%
0/61 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
0.00%
0/61 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
|
Psychiatric disorders
hospitalized-worsening depression and anxiety
|
1.6%
1/62 • Number of events 1 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
0.00%
0/63 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
0.00%
0/61 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
0.00%
0/61 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
|
Psychiatric disorders
hospitalized-depression,anxiety, chronic pain
|
0.00%
0/62 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
1.6%
1/63 • Number of events 1 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
0.00%
0/61 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
0.00%
0/61 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
Other adverse events
| Measure |
MDD With Recent Suicide Attempt
n=62 participants at risk
All subjects with Major Depressive Disorder with a recent Suicide Attempt (in the past 2 weeks) will receive a one-time IV infusion of ketamine at a dose of 0.5mg/kg at a rate of 40mL over 40 minutes. Blood will be drawn at pre-dose, 30 minutes post dose, 180 minutes post dose, 24 hours post dose, and 14 days post dose to measure changes in miRNAs.
ketamine: IV infusion of ketamine 0.5mg/kg at a rate of 40mL over 40 minutes
|
MDD With Suicidal Ideation no Attempt
n=63 participants at risk
All subjects with Major Depressive Disorder with recent Suicidal Ideation (in the past 7 days) without a recent Suicide Attempt (in the past 6 months) will receive a one-time IV infusion of ketamine at a dose of 0.5mg/kg at a rate of 40mL over 40 minutes. Blood will be drawn at pre-dose, 30 minutes post dose, 180 minutes post dose, 24 hours post dose, and 14 days post dose to measure changes in miRNAs.
ketamine: IV infusion of ketamine 0.5mg/kg at a rate of 40mL over 40 minutes
|
MDD Without Suicidal Ideation no Attempt
n=61 participants at risk
All subjects with Major Depressive Disorder without recent Suicidal Ideation (in the past 7 days) without a recent Suicide Attempt (in the past 6 months) will receive a one-time IV infusion of ketamine at a dose of 0.5mg/kg at a rate of 40mL over 40 minutes. Blood will be drawn at pre-dose, 30 minutes post dose, 180 minutes post dose, 24 hours post dose, and 14 days post dose to measure changes in miRNAs.
ketamine: IV infusion of ketamine 0.5mg/kg at a rate of 40mL over 40 minutes
|
Healthy Controls
n=61 participants at risk
Healthy Control subjects without a psychiatric diagnosis will have a one-time blood draw to examine miRNAs.
|
|---|---|---|---|---|
|
General disorders
Dizziness
|
21.0%
13/62 • Number of events 13 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
20.6%
13/63 • Number of events 13 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
26.2%
16/61 • Number of events 16 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
0.00%
0/61 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
|
Nervous system disorders
Numbness
|
24.2%
15/62 • Number of events 15 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
25.4%
16/63 • Number of events 16 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
32.8%
20/61 • Number of events 20 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
0.00%
0/61 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
|
General disorders
Insomnia
|
1.6%
1/62 • Number of events 1 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
1.6%
1/63 • Number of events 1 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
0.00%
0/61 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
0.00%
0/61 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
|
General disorders
Irritability
|
0.00%
0/62 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
4.8%
3/63 • Number of events 3 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
0.00%
0/61 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
0.00%
0/61 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
|
General disorders
Lightheadedness
|
14.5%
9/62 • Number of events 9 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
14.3%
9/63 • Number of events 9 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
11.5%
7/61 • Number of events 7 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
0.00%
0/61 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
|
Musculoskeletal and connective tissue disorders
Muscle or joint pain
|
3.2%
2/62 • Number of events 2 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
4.8%
3/63 • Number of events 3 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
4.9%
3/61 • Number of events 3 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
0.00%
0/61 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
|
Nervous system disorders
Myoclonus/muscle twitching
|
1.6%
1/62 • Number of events 1 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
0.00%
0/63 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
0.00%
0/61 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
0.00%
0/61 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
|
General disorders
Nasal congestion
|
1.6%
1/62 • Number of events 1 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
3.2%
2/63 • Number of events 2 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
0.00%
0/61 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
0.00%
0/61 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
|
Psychiatric disorders
Paranoia
|
4.8%
3/62 • Number of events 3 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
1.6%
1/63 • Number of events 1 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
3.3%
2/61 • Number of events 2 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
0.00%
0/61 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
|
Nervous system disorders
Parasthesia/tingling
|
4.8%
3/62 • Number of events 3 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
3.2%
2/63 • Number of events 2 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
3.3%
2/61 • Number of events 2 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
0.00%
0/61 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
|
General disorders
Phantosmia
|
1.6%
1/62 • Number of events 1 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
1.6%
1/63 • Number of events 1 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
1.6%
1/61 • Number of events 1 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
0.00%
0/61 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.6%
1/62 • Number of events 1 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
0.00%
0/63 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
0.00%
0/61 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
0.00%
0/61 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
|
Nervous system disorders
Restlessness
|
1.6%
1/62 • Number of events 1 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
1.6%
1/63 • Number of events 1 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
0.00%
0/61 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
0.00%
0/61 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
|
General disorders
Sedation
|
1.6%
1/62 • Number of events 1 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
6.3%
4/63 • Number of events 4 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
4.9%
3/61 • Number of events 3 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
0.00%
0/61 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
|
Renal and urinary disorders
Sensation needing to urinate
|
3.2%
2/62 • Number of events 2 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
1.6%
1/63 • Number of events 1 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
0.00%
0/61 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
0.00%
0/61 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
|
Skin and subcutaneous tissue disorders
Skin fissure
|
1.6%
1/62 • Number of events 1 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
0.00%
0/63 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
0.00%
0/61 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
0.00%
0/61 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
|
General disorders
Single nightmare
|
0.00%
0/62 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
0.00%
0/63 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
1.6%
1/61 • Number of events 1 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
0.00%
0/61 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
|
Nervous system disorders
Sweating
|
1.6%
1/62 • Number of events 1 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
1.6%
1/63 • Number of events 1 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
0.00%
0/61 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
0.00%
0/61 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
|
Musculoskeletal and connective tissue disorders
Swelling in extremity
|
0.00%
0/62 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
1.6%
1/63 • Number of events 1 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
0.00%
0/61 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
0.00%
0/61 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
|
Musculoskeletal and connective tissue disorders
Toothache
|
0.00%
0/62 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
0.00%
0/63 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
1.6%
1/61 • Number of events 1 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
0.00%
0/61 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
|
Nervous system disorders
Tremor
|
0.00%
0/62 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
1.6%
1/63 • Number of events 1 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
0.00%
0/61 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
0.00%
0/61 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
|
Renal and urinary disorders
Urinary tract infection
|
0.00%
0/62 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
1.6%
1/63 • Number of events 1 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
0.00%
0/61 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
0.00%
0/61 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
|
Eye disorders
Visual disturbance
|
21.0%
13/62 • Number of events 13 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
14.3%
9/63 • Number of events 9 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
16.4%
10/61 • Number of events 10 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
0.00%
0/61 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/62 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
1.6%
1/63 • Number of events 1 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
0.00%
0/61 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
0.00%
0/61 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
|
Psychiatric disorders
Anxiety
|
6.5%
4/62 • Number of events 4 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
14.3%
9/63 • Number of events 9 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
8.2%
5/61 • Number of events 5 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
0.00%
0/61 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
|
General disorders
Apathy
|
0.00%
0/62 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
1.6%
1/63 • Number of events 1 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
0.00%
0/61 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
0.00%
0/61 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
|
Nervous system disorders
Aphasia
|
1.6%
1/62 • Number of events 1 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
1.6%
1/63 • Number of events 1 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
1.6%
1/61 • Number of events 1 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
0.00%
0/61 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
|
Musculoskeletal and connective tissue disorders
Ataxia
|
3.2%
2/62 • Number of events 2 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
11.1%
7/63 • Number of events 7 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
9.8%
6/61 • Number of events 6 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
0.00%
0/61 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
|
Ear and labyrinth disorders
Auditory disturbance
|
8.1%
5/62 • Number of events 5 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
4.8%
3/63 • Number of events 3 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
8.2%
5/61 • Number of events 5 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
0.00%
0/61 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
|
Cardiac disorders
Cardiovascular disturbance
|
8.1%
5/62 • Number of events 5 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
7.9%
5/63 • Number of events 5 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
6.6%
4/61 • Number of events 4 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
1.6%
1/61 • Number of events 1 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
|
Nervous system disorders
Cold flash
|
0.00%
0/62 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
0.00%
0/63 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
1.6%
1/61 • Number of events 1 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
0.00%
0/61 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
|
General disorders
Crying, tearfulness
|
3.2%
2/62 • Number of events 2 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
4.8%
3/63 • Number of events 3 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
4.9%
3/61 • Number of events 3 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
0.00%
0/61 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
|
General disorders
Difficulty concentrating
|
9.7%
6/62 • Number of events 6 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
7.9%
5/63 • Number of events 5 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
11.5%
7/61 • Number of events 7 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
0.00%
0/61 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
|
Psychiatric disorders
Dissociation
|
24.2%
15/62 • Number of events 15 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
33.3%
21/63 • Number of events 21 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
32.8%
20/61 • Number of events 20 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
0.00%
0/61 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
|
General disorders
Drowsiness,fatigue
|
22.6%
14/62 • Number of events 14 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
27.0%
17/63 • Number of events 17 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
31.1%
19/61 • Number of events 19 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
0.00%
0/61 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
|
General disorders
Dry mouth
|
4.8%
3/62 • Number of events 3 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
14.3%
9/63 • Number of events 9 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
6.6%
4/61 • Number of events 4 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
0.00%
0/61 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
|
General disorders
Dysgeusia
|
11.3%
7/62 • Number of events 7 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
6.3%
4/63 • Number of events 4 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
1.6%
1/61 • Number of events 1 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
0.00%
0/61 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
|
Musculoskeletal and connective tissue disorders
Fall
|
1.6%
1/62 • Number of events 1 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
0.00%
0/63 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
0.00%
0/61 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
0.00%
0/61 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
|
Skin and subcutaneous tissue disorders
Flushing
|
0.00%
0/62 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
3.2%
2/63 • Number of events 2 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
3.3%
2/61 • Number of events 2 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
0.00%
0/61 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
|
Gastrointestinal disorders
Gastrointestinal disturbance
|
12.9%
8/62 • Number of events 8 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
20.6%
13/63 • Number of events 13 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
21.3%
13/61 • Number of events 13 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
0.00%
0/61 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
|
Psychiatric disorders
Hallucination
|
6.5%
4/62 • Number of events 4 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
9.5%
6/63 • Number of events 6 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
0.00%
0/61 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
0.00%
0/61 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
|
General disorders
Headache
|
4.8%
3/62 • Number of events 3 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
9.5%
6/63 • Number of events 6 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
9.8%
6/61 • Number of events 6 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
0.00%
0/61 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
|
Psychiatric disorders
Hypomania
|
24.2%
15/62 • Number of events 15 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
15.9%
10/63 • Number of events 10 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
8.2%
5/61 • Number of events 5 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
0.00%
0/61 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
|
Nervous system disorders
Hot flash
|
1.6%
1/62 • Number of events 1 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
3.2%
2/63 • Number of events 2 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
4.9%
3/61 • Number of events 3 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
0.00%
0/61 • Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
|
Additional Information
Samantha White/ Clinical Trials Manager
University of Alabama at Birmingham
Phone: 12059349189
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place