Trial Outcomes & Findings for Optimization of IV Ketamine for Treatment Resistant Depression (NCT NCT00768430)
NCT ID: NCT00768430
Last Updated: 2014-01-31
Results Overview
Montgomery-Asberg Depression Rating Scale, each of the ten items can be scored from 0 (absence of symptoms to 6 most severe) and has a total score range of 0-60. A lower score on a MADRS indicates a less severe depression.
COMPLETED
PHASE2
73 participants
24 hours post-infusion
2014-01-31
Participant Flow
The study enrolled patients at two academic sites, Baylor College of Medicine and Icahn School of Medicine at Mount Sinai, between November 2010 and August 2012.
The protocol required patients to be drug free prior to the infusion, for at at least 1 week (4 for fluoxetine) for those taking other medications. Randomly assigned in a 2:1 ratio, the patients received a single intravenous infusion of ketamine hydrochloride (0.5 mg/kg) or midazolam (0.045 mg/kg) infused over 40 minutes.
Participant milestones
| Measure |
Ketamine
single infusion of 0.5mg/kg of Ketamine HCL
|
Midazolam
single infusion of midazolam being used as an active control for the study
|
|---|---|---|
|
24 Hour Endpoint
STARTED
|
48
|
25
|
|
24 Hour Endpoint
COMPLETED
|
47
|
25
|
|
24 Hour Endpoint
NOT COMPLETED
|
1
|
0
|
|
7 Day Endpoint
STARTED
|
47
|
25
|
|
7 Day Endpoint
COMPLETED
|
45
|
22
|
|
7 Day Endpoint
NOT COMPLETED
|
2
|
3
|
Reasons for withdrawal
| Measure |
Ketamine
single infusion of 0.5mg/kg of Ketamine HCL
|
Midazolam
single infusion of midazolam being used as an active control for the study
|
|---|---|---|
|
7 Day Endpoint
Withdrawal by Subject
|
2
|
3
|
Baseline Characteristics
Optimization of IV Ketamine for Treatment Resistant Depression
Baseline characteristics by cohort
| Measure |
Ketamine
n=48 Participants
Ketamine
|
Midazolam
n=25 Participants
Midazolam
|
Total
n=73 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
46.9 years
STANDARD_DEVIATION 12.8 • n=5 Participants
|
42.7 years
STANDARD_DEVIATION 11.6 • n=7 Participants
|
44.8 years
STANDARD_DEVIATION 12.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
48 participants
n=5 Participants
|
25 participants
n=7 Participants
|
73 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 hours post-infusionMontgomery-Asberg Depression Rating Scale, each of the ten items can be scored from 0 (absence of symptoms to 6 most severe) and has a total score range of 0-60. A lower score on a MADRS indicates a less severe depression.
Outcome measures
| Measure |
Ketamine
n=47 Participants
Ketamine
|
Midazolam
n=25 Participants
Midazolam
|
|---|---|---|
|
MADRS
|
14.77 units on a scale
Interval 11.73 to 17.8
|
22.72 units on a scale
Interval 18.85 to 26.59
|
Adverse Events
Ketamine
Midazolam
Serious adverse events
| Measure |
Ketamine
n=47 participants at risk
Ketamine
|
Midazolam
n=25 participants at risk
Midazolam
|
|---|---|---|
|
Cardiac disorders
Hypotension/Bradycardia
|
2.1%
1/47 • Number of events 1
|
0.00%
0/25
|
|
Social circumstances
Suicide Attempt
|
2.1%
1/47 • Number of events 1
|
0.00%
0/25
|
Other adverse events
| Measure |
Ketamine
n=47 participants at risk
Ketamine
|
Midazolam
n=25 participants at risk
Midazolam
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
34.0%
16/47
|
12.0%
3/25
|
|
Nervous system disorders
Headache
|
31.9%
15/47
|
20.0%
5/25
|
|
Nervous system disorders
Dizziness on standing
|
21.3%
10/47
|
8.0%
2/25
|
|
Gastrointestinal disorders
Dry Mouth
|
25.5%
12/47
|
16.0%
4/25
|
|
Nervous system disorders
Poor Concentration
|
40.4%
19/47
|
48.0%
12/25
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place