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miRNAs, Suicide, and Ketamine - Plasma Exosomal microRNAs as Novel Biomarkers for Suicidality and Treatment Outcome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02418195
Recruitment Status : Completed
First Posted : April 16, 2015
Results First Posted : July 5, 2022
Last Update Posted : July 28, 2022
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Yogesh Dwivedi, PhD, University of Alabama at Birmingham

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Condition Major Depressive Disorder
Intervention Drug: ketamine
Enrollment 247
Recruitment Details

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.

Pre-assignment Details A number of participants were excluded for not meeting inclusion or meeting exclusion criteria, in total 51. These were considered screen failures.
Arm/Group Title MDD With Recent Suicide Attempt MDD With Suicidal Ideation no Attempt MDD Without Suicidal Ideation no Attempt Healthy Controls
Hide Arm/Group Description

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

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

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 Control subjects without a psychiatric diagnosis will have a one-time blood draw to examine miRNAs.
Period Title: Overall Study
Started 62 [1] 63 [1] 61 [1] 61 [1]
Completed 62 [1] 63 [1] 61 [1] 61 [1]
Not Completed 0 0 0 0
[1]
Number subjects screened in this group.
Arm/Group Title MDD With Recent Suicide Attempt MDD With Suicidal Ideation no Attempt MDD Without Suicidal Ideation no Attempt Healthy Controls Total
Hide Arm/Group Description

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

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

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 Control subjects without a psychiatric diagnosis will have a one-time blood draw to examine miRNAs. Total of all reporting groups
Overall Number of Baseline Participants 62 63 61 61 247
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 62 participants 63 participants 61 participants 61 participants 247 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
62
 100.0%
63
 100.0%
61
 100.0%
61
 100.0%
247
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 62 participants 63 participants 61 participants 61 participants 247 participants
35.53  (11.70) 39.94  (14.05) 44.62  (12.26) 37.54  (12.65) 39.40  (13.07)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 62 participants 63 participants 61 participants 61 participants 247 participants
Female
36
  58.1%
43
  68.3%
36
  59.0%
35
  57.4%
150
  60.7%
Male
26
  41.9%
20
  31.7%
25
  41.0%
26
  42.6%
97
  39.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 62 participants 63 participants 61 participants 61 participants 247 participants
Hispanic or Latino
2
   3.2%
1
   1.6%
2
   3.3%
1
   1.6%
6
   2.4%
Not Hispanic or Latino
60
  96.8%
62
  98.4%
59
  96.7%
60
  98.4%
241
  97.6%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 62 participants 63 participants 61 participants 61 participants 247 participants
American Indian or Alaska Native
2
   3.2%
0
   0.0%
0
   0.0%
0
   0.0%
2
   0.8%
Asian
1
   1.6%
2
   3.2%
0
   0.0%
3
   4.9%
6
   2.4%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
13
  21.0%
10
  15.9%
11
  18.0%
13
  21.3%
47
  19.0%
White
46
  74.2%
51
  81.0%
50
  82.0%
45
  73.8%
192
  77.7%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 62 participants 63 participants 61 participants 61 participants 247 participants
62 63 61 61 247
Number enrolled  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 62 participants 63 participants 61 participants 61 participants 247 participants
62
 100.0%
63
 100.0%
61
 100.0%
61
 100.0%
247
 100.0%
1.Primary Outcome
Title Beck Scale for Suicide Ideation (BSS)
Hide Description

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.

Time Frame 180 minutes post dose
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MDD With Recent Suicide Attempt MDD With Suicidal Ideation no Attempt MDD Without Suicidal Ideation no Attempt
Hide Arm/Group Description:

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

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

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

Overall Number of Participants Analyzed 56 56 60
Mean (Standard Deviation)
Unit of Measure: units on a scale
9.09  (9.843) 8.46  (8.954) 1.9  (3.551)
2.Secondary Outcome
Title Montgomery Asberg Depression Rating Scale (MADRS)
Hide Description

The 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

Time Frame 180 minutes post dose
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MDD With Recent Suicide Attempt MDD With Suicidal Ideation no Attempt MDD Without Suicidal Ideation no Attempt
Hide Arm/Group Description:

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

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

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

Overall Number of Participants Analyzed 56 56 60
Mean (Standard Deviation)
Unit of Measure: units on a scale
11.7  (10.582) 11.56  (8.981) 8.14  (5.338)
3.Secondary Outcome
Title Beck Depression Inventory (BDI)
Hide Description

The 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.

Time Frame 180 minutes post dose
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MDD With Recent Suicide Attempt MDD With Suicidal Ideation no Attempt MDD Without Suicidal Ideation no Attempt
Hide Arm/Group Description:

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

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

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

Overall Number of Participants Analyzed 56 56 60
Mean (Standard Deviation)
Unit of Measure: units on a scale
18.02  (17.466) 15.85  (14.641) 12.12  (10.738)
4.Secondary Outcome
Title Beck Anxiety Inventory (BAI)
Hide Description

The 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

Time Frame 180 minutes post dose
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MDD With Recent Suicide Attempt MDD With Suicidal Ideation no Attempt MDD Without Suicidal Ideation no Attempt
Hide Arm/Group Description:

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

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

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

Overall Number of Participants Analyzed 46 54 59
Mean (Standard Deviation)
Unit of Measure: units on a scale
6.76  (10.025) 6.59  (11.190) 3.31  (5.240)
5.Secondary Outcome
Title Beck Hopelessness Scale (BHS)
Hide Description

The 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.

Time Frame 180 minutes post dose
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MDD With Recent Suicide Attempt MDD With Suicidal Ideation no Attempt MDD Without Suicidal Ideation no Attempt
Hide Arm/Group Description:

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

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

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

Overall Number of Participants Analyzed 56 56 60
Mean (Standard Deviation)
Unit of Measure: units on a scale
8.25  (6.641) 8.35  (6.253) 7.22  (5.781)
6.Secondary Outcome
Title 4-item Brief Psychiatric Rating Scale (BPRS)
Hide Description

The 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.

Time Frame 180 minutes post dose
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MDD With Recent Suicide Attempt MDD With Suicidal Ideation no Attempt MDD Without Suicidal Ideation no Attempt
Hide Arm/Group Description:

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

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

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

Overall Number of Participants Analyzed 56 56 60
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.02  (0.151) 0.04  (0.272) 0.03  (0.26)
7.Secondary Outcome
Title Clinician-Administered Dissociative States Scale (CADSS)
Hide Description

The 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.

Time Frame 180 minutes post dose
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MDD With Recent Suicide Attempt MDD With Suicidal Ideation no Attempt MDD Without Suicidal Ideation no Attempt
Hide Arm/Group Description:

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

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

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

Overall Number of Participants Analyzed 56 56 60
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.5  (0.902) 0.37  (0.853) 0.34  (0.801)
8.Secondary Outcome
Title Young Mania Rating Scale (YMRS)
Hide Description This 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.
Time Frame 180 minutes post dose
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MDD With Recent Suicide Attempt MDD With Suicidal Ideation no Attempt MDD Without Suicidal Ideation no Attempt
Hide Arm/Group Description:

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

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

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

Overall Number of Participants Analyzed 46 55 59
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.61  (1.879) 2.02  (3.240) 0.85  (1.311)
9.Secondary Outcome
Title Systematic Assessment for Treatment Emergent Events (SAFTEE)
Hide Description

The 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.

Time Frame 180 minutes post dose
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MDD With Recent Suicide Attempt MDD With Suicidal Ideation no Attempt MDD Without Suicidal Ideation no Attempt
Hide Arm/Group Description:

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

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

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

Overall Number of Participants Analyzed 56 56 60
Mean (Standard Deviation)
Unit of Measure: units on a scale
20.66  (26.755) 18.67  (26.36) 11.81  (13.058)
Time Frame Participants were assessed for any adverse events from time of Screening visit, until after completion of Day 14 visit.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title MDD With Recent Suicide Attempt MDD With Suicidal Ideation no Attempt MDD Without Suicidal Ideation no Attempt Healthy Controls
Hide Arm/Group Description

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

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

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 Control subjects without a psychiatric diagnosis will have a one-time blood draw to examine miRNAs.
All-Cause Mortality
MDD With Recent Suicide Attempt MDD With Suicidal Ideation no Attempt MDD Without Suicidal Ideation no Attempt Healthy Controls
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/62 (0.00%)      0/63 (0.00%)      0/61 (0.00%)      0/61 (0.00%)    
Hide Serious Adverse Events
MDD With Recent Suicide Attempt MDD With Suicidal Ideation no Attempt MDD Without Suicidal Ideation no Attempt Healthy Controls
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/62 (8.06%)      1/63 (1.59%)      1/61 (1.64%)      0/61 (0.00%)    
Cardiac disorders         
elevated blood pressure *  0/62 (0.00%)  0 0/63 (0.00%)  0 1/61 (1.64%)  1 0/61 (0.00%)  0
Psychiatric disorders         
worsening depression and SI *  1/62 (1.61%)  1 0/63 (0.00%)  0 0/61 (0.00%)  0 0/61 (0.00%)  0
suicide attempt *  1/62 (1.61%)  1 0/63 (0.00%)  0 0/61 (0.00%)  0 0/61 (0.00%)  0
altered mental status *  1/62 (1.61%)  1 0/63 (0.00%)  0 0/61 (0.00%)  0 0/61 (0.00%)  0
acute worsening depression *  1/62 (1.61%)  1 0/63 (0.00%)  0 0/61 (0.00%)  0 0/61 (0.00%)  0
hospitalized-worsening depression and anxiety *  1/62 (1.61%)  1 0/63 (0.00%)  0 0/61 (0.00%)  0 0/61 (0.00%)  0
hospitalized-depression,anxiety, chronic pain *  0/62 (0.00%)  0 1/63 (1.59%)  1 0/61 (0.00%)  0 0/61 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
MDD With Recent Suicide Attempt MDD With Suicidal Ideation no Attempt MDD Without Suicidal Ideation no Attempt Healthy Controls
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   47/62 (75.81%)      58/63 (92.06%)      60/61 (98.36%)      1/61 (1.64%)    
Cardiac disorders         
Cardiovascular disturbance *  5/62 (8.06%)  5 5/63 (7.94%)  5 4/61 (6.56%)  4 1/61 (1.64%)  1
Ear and labyrinth disorders         
Auditory disturbance *  5/62 (8.06%)  5 3/63 (4.76%)  3 5/61 (8.20%)  5 0/61 (0.00%)  0
Eye disorders         
Visual disturbance *  13/62 (20.97%)  13 9/63 (14.29%)  9 10/61 (16.39%)  10 0/61 (0.00%)  0
Gastrointestinal disorders         
Gastrointestinal disturbance *  8/62 (12.90%)  8 13/63 (20.63%)  13 13/61 (21.31%)  13 0/61 (0.00%)  0
General disorders         
Dizziness *  13/62 (20.97%)  13 13/63 (20.63%)  13 16/61 (26.23%)  16 0/61 (0.00%)  0
Insomnia *  1/62 (1.61%)  1 1/63 (1.59%)  1 0/61 (0.00%)  0 0/61 (0.00%)  0
Irritability *  0/62 (0.00%)  0 3/63 (4.76%)  3 0/61 (0.00%)  0 0/61 (0.00%)  0
Lightheadedness *  9/62 (14.52%)  9 9/63 (14.29%)  9 7/61 (11.48%)  7 0/61 (0.00%)  0
Nasal congestion *  1/62 (1.61%)  1 2/63 (3.17%)  2 0/61 (0.00%)  0 0/61 (0.00%)  0
Phantosmia *  1/62 (1.61%)  1 1/63 (1.59%)  1 1/61 (1.64%)  1 0/61 (0.00%)  0
Sedation *  1/62 (1.61%)  1 4/63 (6.35%)  4 3/61 (4.92%)  3 0/61 (0.00%)  0
Single nightmare *  0/62 (0.00%)  0 0/63 (0.00%)  0 1/61 (1.64%)  1 0/61 (0.00%)  0
Apathy *  0/62 (0.00%)  0 1/63 (1.59%)  1 0/61 (0.00%)  0 0/61 (0.00%)  0
Crying, tearfulness *  2/62 (3.23%)  2 3/63 (4.76%)  3 3/61 (4.92%)  3 0/61 (0.00%)  0
Difficulty concentrating *  6/62 (9.68%)  6 5/63 (7.94%)  5 7/61 (11.48%)  7 0/61 (0.00%)  0
Drowsiness,fatigue *  14/62 (22.58%)  14 17/63 (26.98%)  17 19/61 (31.15%)  19 0/61 (0.00%)  0
Dry mouth *  3/62 (4.84%)  3 9/63 (14.29%)  9 4/61 (6.56%)  4 0/61 (0.00%)  0
Dysgeusia *  7/62 (11.29%)  7 4/63 (6.35%)  4 1/61 (1.64%)  1 0/61 (0.00%)  0
Headache *  3/62 (4.84%)  3 6/63 (9.52%)  6 6/61 (9.84%)  6 0/61 (0.00%)  0
Musculoskeletal and connective tissue disorders         
Muscle or joint pain *  2/62 (3.23%)  2 3/63 (4.76%)  3 3/61 (4.92%)  3 0/61 (0.00%)  0
Swelling in extremity *  0/62 (0.00%)  0 1/63 (1.59%)  1 0/61 (0.00%)  0 0/61 (0.00%)  0
Toothache *  0/62 (0.00%)  0 0/63 (0.00%)  0 1/61 (1.64%)  1 0/61 (0.00%)  0
Ataxia *  2/62 (3.23%)  2 7/63 (11.11%)  7 6/61 (9.84%)  6 0/61 (0.00%)  0
Fall *  1/62 (1.61%)  1 0/63 (0.00%)  0 0/61 (0.00%)  0 0/61 (0.00%)  0
Nervous system disorders         
Numbness *  15/62 (24.19%)  15 16/63 (25.40%)  16 20/61 (32.79%)  20 0/61 (0.00%)  0
Myoclonus/muscle twitching *  1/62 (1.61%)  1 0/63 (0.00%)  0 0/61 (0.00%)  0 0/61 (0.00%)  0
Parasthesia/tingling *  3/62 (4.84%)  3 2/63 (3.17%)  2 2/61 (3.28%)  2 0/61 (0.00%)  0
Restlessness *  1/62 (1.61%)  1 1/63 (1.59%)  1 0/61 (0.00%)  0 0/61 (0.00%)  0
Sweating *  1/62 (1.61%)  1 1/63 (1.59%)  1 0/61 (0.00%)  0 0/61 (0.00%)  0
Tremor *  0/62 (0.00%)  0 1/63 (1.59%)  1 0/61 (0.00%)  0 0/61 (0.00%)  0
Aphasia *  1/62 (1.61%)  1 1/63 (1.59%)  1 1/61 (1.64%)  1 0/61 (0.00%)  0
Cold flash *  0/62 (0.00%)  0 0/63 (0.00%)  0 1/61 (1.64%)  1 0/61 (0.00%)  0
Hot flash *  1/62 (1.61%)  1 2/63 (3.17%)  2 3/61 (4.92%)  3 0/61 (0.00%)  0
Psychiatric disorders         
Paranoia *  3/62 (4.84%)  3 1/63 (1.59%)  1 2/61 (3.28%)  2 0/61 (0.00%)  0
Anxiety *  4/62 (6.45%)  4 9/63 (14.29%)  9 5/61 (8.20%)  5 0/61 (0.00%)  0
Dissociation *  15/62 (24.19%)  15 21/63 (33.33%)  21 20/61 (32.79%)  20 0/61 (0.00%)  0
Hallucination *  4/62 (6.45%)  4 6/63 (9.52%)  6 0/61 (0.00%)  0 0/61 (0.00%)  0
Hypomania *  15/62 (24.19%)  15 10/63 (15.87%)  10 5/61 (8.20%)  5 0/61 (0.00%)  0
Renal and urinary disorders         
Sensation needing to urinate *  2/62 (3.23%)  2 1/63 (1.59%)  1 0/61 (0.00%)  0 0/61 (0.00%)  0
Urinary tract infection *  0/62 (0.00%)  0 1/63 (1.59%)  1 0/61 (0.00%)  0 0/61 (0.00%)  0
Skin and subcutaneous tissue disorders         
Rash *  1/62 (1.61%)  1 0/63 (0.00%)  0 0/61 (0.00%)  0 0/61 (0.00%)  0
Skin fissure *  1/62 (1.61%)  1 0/63 (0.00%)  0 0/61 (0.00%)  0 0/61 (0.00%)  0
Acne *  0/62 (0.00%)  0 1/63 (1.59%)  1 0/61 (0.00%)  0 0/61 (0.00%)  0
Flushing *  0/62 (0.00%)  0 2/63 (3.17%)  2 2/61 (3.28%)  2 0/61 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Samantha White/ Clinical Trials Manager
Organization: University of Alabama at Birmingham
Phone: 12059349189
EMail: swwhite@uabmc.edu
Layout table for additonal information
Responsible Party: Yogesh Dwivedi, PhD, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT02418195    
Other Study ID Numbers: F141029007
1R01MH107183-01 ( U.S. NIH Grant/Contract )
First Submitted: April 13, 2015
First Posted: April 16, 2015
Results First Submitted: March 8, 2022
Results First Posted: July 5, 2022
Last Update Posted: July 28, 2022