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Ketamine as a Rapidly-Acting Antidepressant in Depressed Emergency Department Patients

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ClinicalTrials.gov Identifier: NCT02106325
Recruitment Status : Completed
First Posted : April 8, 2014
Results First Posted : September 14, 2018
Last Update Posted : September 14, 2018
Sponsor:
Information provided by (Responsible Party):
New York University School of Medicine

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Depression
Interventions Drug: Ketamine
Drug: Diphenhydramine
Enrollment 21

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Ketamine Diphenhydramine
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IV Ketamine .25mg/kg

Ketamine: IV of Ketamine (.25mg/kg)

25mg Diphenhydramine

Diphenhydramine: Intravenous Diphenhydramine (25mg) at the time of presentation to Emergency Department

Period Title: Phase 1
Started 5 3
Completed 3 1
Not Completed 2 2
Reason Not Completed
Lost to Follow-up             2             2
Period Title: Phase 2
Started 4 4
Completed 2 1
Not Completed 2 3
Reason Not Completed
Lost to Follow-up             2             3
Period Title: Phase 3
Started 2 3
Completed 0 2
Not Completed 2 1
Reason Not Completed
Lost to Follow-up             2             1
Arm/Group Title Ketamine Diphenhydramine Total
Hide Arm/Group Description

IV Ketamine .25mg/kg

Ketamine: IV of Ketamine (.25mg/kg)

25mg Diphenhydramine

Diphenhydramine: Intravenous Diphenhydramine (25mg) at the time of presentation to Emergency Department

Total of all reporting groups
Overall Number of Baseline Participants 11 10 21
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 11 participants 10 participants 21 participants
40
(22 to 57)
31
(22 to 48)
38
(22 to 57)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 10 participants 21 participants
Female
4
  36.4%
4
  40.0%
8
  38.1%
Male
7
  63.6%
6
  60.0%
13
  61.9%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 10 participants 21 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
   9.1%
0
   0.0%
1
   4.8%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
   9.1%
0
   0.0%
1
   4.8%
White
8
  72.7%
10
 100.0%
18
  85.7%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
1
   9.1%
0
   0.0%
1
   4.8%
1.Primary Outcome
Title Evaluate the Effects of Ketamine on Depressive Symptomatology by Measuring Change in Score on the Montgomery-Asberg Depressive Rating Scale
Hide Description

40 Minutes Post Infusion, The MADRS-S instrument has nine questions, with an overall score ranging from 0 to 54 points.

0 to 6 – normal /symptom absent 7 to 19 – mild depression 20 to 34 – moderate depression >34 – severe depression.

Time Frame Baseline and 16 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ketamine Diphenhydramine
Hide Arm/Group Description:

IV Ketamine .25mg/kg

Ketamine: IV of Ketamine (.25mg/kg)

25mg Diphenhydramine

Diphenhydramine: Intravenous Diphenhydramine (25mg) at the time of presentation to Emergency Department

Overall Number of Participants Analyzed 11 10
Mean (Standard Error)
Unit of Measure: units on a scale
28.82  (2.95) 25.20  (3.10)
2.Primary Outcome
Title Beck Depression Inventory-II (BDI-II)
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BDI-II items are rated on a 4-point scale ranging from 0 to 3 based on severity of each item. The maximum total score is 63.

0-13 Indicates minimal depression 14-19 Indicates mild depression 20-28 Indicates Moderate depression 29-63 Indicates Severe depression

Time Frame 120 min post-infusion
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ketamine Diphenhydramine
Hide Arm/Group Description:

IV Ketamine .25mg/kg

Ketamine: IV of Ketamine (.25mg/kg)

25mg Diphenhydramine

Diphenhydramine: Intravenous Diphenhydramine (25mg) at the time of presentation to Emergency Department

Overall Number of Participants Analyzed 11 10
Mean (Standard Error)
Unit of Measure: Scored units on a scale
20.00  (3.94) 24.72  (4.06)
3.Primary Outcome
Title Hamilton Depression Scale (Ham-D)
Hide Description

Although the HAM-D form lists 21 items, the scoring is based on the first 17. It generally takes 15-20 minutes to complete the interview and score the results. Eight items are scored on a 5-point scale, ranging from 0 = not present to 4 = severe. Nine are scored from 0-2.

Sum the scores from the first 17 items 0-7= Normal 8-13= Mild Depression 14-18= Moderate Depression 19-22= Severe Depression >23= Very Severe Depression

Time Frame 4-6 hours post-infusion
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ketamine Diphenhydramine
Hide Arm/Group Description:

IV Ketamine .25mg/kg

Ketamine: IV of Ketamine (.25mg/kg)

25mg Diphenhydramine

Diphenhydramine: Intravenous Diphenhydramine (25mg) at the time of presentation to Emergency Department

Overall Number of Participants Analyzed 11 10
Mean (Standard Error)
Unit of Measure: Scored units on a scale
21.48  (2.08) 17.00  (2.26)
4.Secondary Outcome
Title Change in Treatment Alliance Score
Hide Description The I-TAS is a 10-item, Likert-style rating scale designed to assess a patient's composite treatment alliance as it develops across multi-disciplinary treatment components. The I-TAS was intended to measure the primary alliance factors identified by Hatcher and Barends (1996) of bond, goals and collaboration. Each question is scored on a scale of 0 (Completely False) to 6 (Completely True). Total scores on the ITAS range from 0 to 60, with higher scores representing greater alliance with the treatment team (better outcome). The reported score is an average of each participant's total score on the ITAS.
Time Frame Baseline and 16 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ketamine Diphenhydramine
Hide Arm/Group Description:

IV Ketamine .25mg/kg

Ketamine: IV of Ketamine (.25mg/kg)

25mg Diphenhydramine

Diphenhydramine: Intravenous Diphenhydramine (25mg) at the time of presentation to Emergency Department

Overall Number of Participants Analyzed 11 10
Mean (Standard Error)
Unit of Measure: Scored units on a scale
43.52  (3.69) 53.15  (4.17)
5.Secondary Outcome
Title Beck Scale for Suicidal Ideation (BSSI)
Hide Description

BDI-II items are rated on a 4-point scale ranging from 0 to 3 based on severity of each item. The maximum total score is 63.

0-13 Indicates minimal depression 14-19 Indicates mild depression 20-28 Indicates Moderate depression 29-63 Indicates Severe depression

Time Frame 40 minutes post-infusion
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ketamine Diphenhydramine
Hide Arm/Group Description:

IV Ketamine .25mg/kg

Ketamine: IV of Ketamine (.25mg/kg)

25mg Diphenhydramine

Diphenhydramine: Intravenous Diphenhydramine (25mg) at the time of presentation to Emergency Department

Overall Number of Participants Analyzed 11 10
Mean (Standard Error)
Unit of Measure: units on a scale
1.58  (1.40) 1.08  (1.42)
6.Secondary Outcome
Title Montgomery–Åsberg Depression Rating Scale Suicide Ideation Item (MADRS-SI)
Hide Description

40 Minutes Post Infusion, The MADRS-S instrument has nine questions, with an overall score ranging from 0 to 54 points.

0 to 6 – normal /symptom absent 7 to 19 – mild depression 20 to 34 – moderate depression >34 – severe depression.

Time Frame 40 minutes post-infusion
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ketamine Diphenhydramine
Hide Arm/Group Description:

IV Ketamine .25mg/kg

Ketamine: IV of Ketamine (.25mg/kg)

25mg Diphenhydramine

Diphenhydramine: Intravenous Diphenhydramine (25mg) at the time of presentation to Emergency Department

Overall Number of Participants Analyzed 11 10
Mean (Standard Error)
Unit of Measure: units on a scale
0.83  (0.46) 0.75  (0.40)
7.Secondary Outcome
Title Length of Inpatient Stay
Hide Description [Not Specified]
Time Frame 2 Weeks Post-infusion
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ketamine Diphenhydramine
Hide Arm/Group Description:

IV Ketamine .25mg/kg

Ketamine: IV of Ketamine (.25mg/kg)

25mg Diphenhydramine

Diphenhydramine: Intravenous Diphenhydramine (25mg) at the time of presentation to Emergency Department

Overall Number of Participants Analyzed 11 10
Mean (Standard Error)
Unit of Measure: Days
6.33  (1.32) 7.80  (1.25)
8.Secondary Outcome
Title Outpatient Follow-up Compliance
Hide Description Scoring System: 0= not compliant, 1=compliant
Time Frame 1 Day
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ketamine Diphenhydramine
Hide Arm/Group Description:

IV Ketamine .25mg/kg

Ketamine: IV of Ketamine (.25mg/kg)

25mg Diphenhydramine

Diphenhydramine: Intravenous Diphenhydramine (25mg) at the time of presentation to Emergency Department

Overall Number of Participants Analyzed 11 10
Mean (Standard Error)
Unit of Measure: units on follow up compliance scale
0.73  (.14) .70  (.14)
9.Secondary Outcome
Title Inpatient Treatment Alliance Scale (ITAS)
Hide Description The I-TAS is a 10-item, Likert-style rating scale designed to assess a patient's composite treatment alliance as it develops across multi-disciplinary treatment components. The I-TAS was intended to measure the primary alliance factors identified by Hatcher and Barends (1996) of bond, goals and collaboration. Each question is scored on a scale of 0 (Completely False) to 6 (Completely True). Total scores on the ITAS range from 0 to 60, with higher scores representing greater alliance with the treatment team (better outcome). The reported score is an average of each participant's total score on the ITAS.
Time Frame 7 days post-infusion
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ketamine Diphenhydramine
Hide Arm/Group Description:

IV Ketamine .25mg/kg

Ketamine: IV of Ketamine (.25mg/kg)

25mg Diphenhydramine

Diphenhydramine: Intravenous Diphenhydramine (25mg) at the time of presentation to Emergency Department

Overall Number of Participants Analyzed 11 10
Mean (Standard Error)
Unit of Measure: Scored units on ITAS Scale
43.52  (3.69) 53.15  (4.17)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ketamine Diphenhydramine
Hide Arm/Group Description

IV Ketamine .25mg/kg

Ketamine: IV of Ketamine (.25mg/kg)

25mg Diphenhydramine

Diphenhydramine: Intravenous Diphenhydramine (25mg) at the time of presentation to Emergency Department

All-Cause Mortality
Ketamine Diphenhydramine
Affected / at Risk (%) Affected / at Risk (%)
Total   0/11 (0.00%)      0/10 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Ketamine Diphenhydramine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/11 (9.09%)      0/10 (0.00%)    
Psychiatric disorders     
Psychosis and Suicidality   1/11 (9.09%)  1 0/10 (0.00%)  0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Ketamine Diphenhydramine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   8/11 (72.73%)      8/10 (80.00%)    
General disorders     
Tiredness   1/11 (9.09%)  1 3/10 (30.00%)  3
Perceptual Disturbance   2/11 (18.18%)  2 2/10 (20.00%)  2
Headache   1/11 (9.09%)  1 0/10 (0.00%)  0
Dizziness   2/11 (18.18%)  2 1/10 (10.00%)  1
Toe Numbness   0/11 (0.00%)  0 1/10 (10.00%)  1
GI Distress   2/11 (18.18%)  2 0/10 (0.00%)  0
Vascular disorders     
Elevated Systolic BP   0/11 (0.00%)  0 1/10 (10.00%)  1
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Stephen Ross, MD/ Principal Investigator
Organization: New York University School of Medicine
Phone: 212 562 4097
Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT02106325     History of Changes
Other Study ID Numbers: 13-00794
First Submitted: December 12, 2013
First Posted: April 8, 2014
Results First Submitted: June 19, 2017
Results First Posted: September 14, 2018
Last Update Posted: September 14, 2018