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Ketamine For Suicidal Ideation

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ClinicalTrials.gov Identifier: NCT01507181
Recruitment Status : Completed
First Posted : January 10, 2012
Results First Posted : February 8, 2017
Last Update Posted : February 8, 2017
Sponsor:
Information provided by (Responsible Party):
James Murrough, Icahn School of Medicine at Mount Sinai

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Suicidal Ideation
Interventions Drug: Ketamine
Drug: Midazolam
Enrollment 24
Recruitment Details Participants were recruited through the inpatient psychiatric service or through an academic outpatient psychiatric clinic. All study treatments were performed at Mount Sinai Hospital between April 2012 and June 2014.
Pre-assignment Details  
Arm/Group Title Ketamine Midazolam
Hide Arm/Group Description

single dose IV ketamine, .5mg/kg

Ketamine: single dose IV ketamine, .5mg/kg infused over 40 minutes

single dose IV midazolam, .45mg/kg

Midazolam: single dose IV midazolam, .45mg/kg infused over 40 minutes

Period Title: Overall Study
Started 12 12
Completed 12 12
Not Completed 0 0
Arm/Group Title Ketamine Midazolam Total
Hide Arm/Group Description single dose IV ketamine, .5mg/kg single dose IV midazolam, .45mg/kg Total of all reporting groups
Overall Number of Baseline Participants 12 12 24
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 12 participants 12 participants 24 participants
45.8  (15.2) 39.1  (10.6) 42.4  (13.3)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 12 participants 24 participants
Female
8
  66.7%
8
  66.7%
16
  66.7%
Male
4
  33.3%
4
  33.3%
8
  33.3%
History of suicide attempt  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 12 participants 12 participants 24 participants
yes 6 9 15
no 6 3 9
BSI score, baseline   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 12 participants 12 participants 24 participants
17.5  (7.2) 17.9  (11.9) 17.7  (9.7)
[1]
Measure Description: Beck Scale for Suicidal Ideation - Beck Scale is a 21-item self or clinician administered instrumentation used to measure the current intensity of patients' specific attitudes, behaviors and plans to commit suicide. Score range 0-42, with higher score indicating higher intensity.
MADRS score, baseline   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 12 participants 12 participants 24 participants
35.2  (6.1) 34.3  (4.1) 34.8  (5.1)
[1]
Measure Description: The Montgomery–Asberg Depression Rating Scale – The MADRS is a 10-item instrument used for the evaluation of depressive symptoms in adults and for the assessment of any changes to those symptoms. Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60.
Primary Diagnosis  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 12 participants 12 participants 24 participants
MDD 6 7 13
Bipolar disorder 4 3 7
PTSD 1 2 3
BPD 1 0 1
Co-occurring disorders  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 12 participants 12 participants 24 participants
MDD 2 2 4
PTSD 2 1 3
BPD 1 0 1
Panic disorder 3 1 4
SAD 2 4 6
OCD 3 3 6
GAD 5 1 6
1.Primary Outcome
Title Change in Beck Scale for Suicidal Ideation (BSSI)
Hide Description Change in BSI score at 24 hours following treatment as compared to baseline. Beck Scale is a 21-item self or clinician administered instrumentation used to measure the current intensity of patients' specific attitudes, behaviors and plans to commit suicide. Score range 0-42, with higher score indicating higher intensity.
Time Frame baseline and 24 hours post infusion
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ketamine Midazolam
Hide Arm/Group Description:
single dose IV ketamine, .5mg/kg
single dose IV midazolam, .045mg/kg
Overall Number of Participants Analyzed 12 12
Mean (Standard Deviation)
Unit of Measure: units on a scale
10.8  (8.5) 14.0  (10.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ketamine, Midazolam
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.32
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
2.Primary Outcome
Title Change in Beck Scale for Suicidal Ideation (BSSI)
Hide Description Change in BSI score at 48 hours following treatment as compared to baseline. Beck Scale is a 21-item self or clinician administered instrumentation used to measure the current intensity of patients' specific attitudes, behaviors and plans to commit suicide. Score range 0-42, with higher score indicating higher intensity.
Time Frame baseline and 48 hours post infusion
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ketamine Midazolam
Hide Arm/Group Description:
single dose IV ketamine, .5mg/kg
single dose IV midazolam, .045mg/kg
Overall Number of Participants Analyzed 12 12
Mean (Standard Deviation)
Unit of Measure: units on a scale
8.8  (8.3) 15.3  (10.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ketamine, Midazolam
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.047
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
3.Secondary Outcome
Title Montgomery-Asberg Depression Rating Scale (MADRS)
Hide Description The MADRS is a 10-item instrument used for the evaluation of depressive symptoms in adults and for the assessment of any changes to those symptoms. Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60.
Time Frame up to 7 days post infusion
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ketamine Midazolam
Hide Arm/Group Description:
single dose IV ketamine, .5mg/kg
single dose IV midazolam, .045mg/kg
Overall Number of Participants Analyzed 12 12
Mean (Standard Deviation)
Unit of Measure: units on a scale
24 hours 19.0  (15.5) 26.2  (10.8)
48 hours 19.3  (13.5) 28  (12.3)
72 hours 20.9  (14.5) 24.1  (12.2)
7 days 21.7  (13.1) 22.2  (13.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ketamine, Midazolam
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.17
Comments Statistics are calculated by comparing 24-h scores using separate ANCOVAs and controlling for baseline severity.
Method ANCOVA
Comments [Not Specified]
4.Secondary Outcome
Title Suicidality Item of the MADRS (MADRS-SI)
Hide Description The MADRS-SI ranges from 0 to 6; a score of 2 corresponds to fleeting, passive SI; a score of 4 indicates that SI is frequent with at least moderate intensity but without specific plans or intention; a score of 6 corresponds to active intention and planning for suicide.
Time Frame 24 hours post infusion
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ketamine Midazolam
Hide Arm/Group Description:
single dose IV ketamine, .5mg/kg
single dose IV midazolam, .045mg/kg
Overall Number of Participants Analyzed 12 12
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.8  (1.9) 3.3  (1.6)
5.Secondary Outcome
Title The Young Mania Rating Scale (YMRS)
Hide Description An 11-item questionnaire, used to assess manic symptoms based on the patient's subjective report of his or her clinical condition. There are four items that are graded on a 0 to 8 scale (irritability, speech, thought content, and disruptive/aggressive behavior), while the remaining seven items are graded on a 0 to 4 scale. The scores from each question are added together to form a total score ranging from 0 to 60, with higher scores indicating a greater severity of symptoms.
Time Frame baseline, 40 minutes post infusion, 240 minutes post infusion
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ketamine Midazolam
Hide Arm/Group Description:
single dose IV ketamine, .5mg/kg
single dose IV midazolam, .045mg/kg
Overall Number of Participants Analyzed 12 12
Mean (Standard Deviation)
Unit of Measure: units on a scale
baseline 0.0  (0.0) 0.1  (0.3)
40 minutes post infusion 0.0  (0.0) 0.3  (0.6)
240 minutes post infusion 0.2  (0.6) 0.2  (0.6)
6.Secondary Outcome
Title The Brief Psychiatric Rating Scale (BPRS)
Hide Description The BPRS measures psychomimetic effects with higher scores indicating more severe symptoms (scale range 7 – 49).
Time Frame baseline, 40 minutes post infusion, and 240 minutes post infusion
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ketamine Midazolam
Hide Arm/Group Description:
single dose IV ketamine, .5mg/kg
single dose IV midazolam, .045mg/kg
Overall Number of Participants Analyzed 12 12
Mean (Standard Deviation)
Unit of Measure: units on a scale
baseline 7.7  (1.12) 7.7  (1.3)
40 minutes post infusion 9.9  (3.3) 7.9  (1.8)
240 minutes post infusion 8.1  (1.6) 7.0  (0.1)
7.Secondary Outcome
Title The Clinician-Administered Dissociative States Scale (CADSS)
Hide Description The CADSS measures dissociation with higher scores indicating more severe symptoms (scale range 0 – 92).
Time Frame baseline, 40 minutes post infusion and 240 minutes post infusion
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ketamine Midazolam
Hide Arm/Group Description:
single dose IV ketamine, .5mg/kg
single dose IV midazolam, .045mg/kg
Overall Number of Participants Analyzed 12 12
Mean (Standard Deviation)
Unit of Measure: units on a scale
baseline 1.1  (2.6) 4.0  (7.0)
40 minutes post infusion 17.1  (19.9) 3.3  (3.1)
240 minutes post infusion 1.2  (1.9) 1.3  (2.6)
8.Secondary Outcome
Title Patient Rated Inventory of Side Effects (PRISE)
Hide Description The PRISE assesses the presence of treatment side effects in nine organ/function systems (gastrointestinal, nervous system, heart, eyes/ears, skin, genital/urinary, sleep, sexual functioning, and other). Data reported in in Adverse Events section.
Time Frame duration of study
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ketamine Midazolam
Hide Arm/Group Description:
single dose IV ketamine, .5mg/kg
single dose IV midazolam, .045mg/kg
Overall Number of Participants Analyzed 12 12
Measure Type: Number
Unit of Measure: events
29 23
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ketamine Midazolam
Hide Arm/Group Description single dose IV ketamine, .5mg/kg single dose IV midazolam, .45mg/kg
All-Cause Mortality
Ketamine Midazolam
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Ketamine Midazolam
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/12 (41.67%)      0/12 (0.00%)    
Psychiatric disorders     
Hospitalizations  1 [1]  4/12 (33.33%)  0/12 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Death  1 [2]  1/12 (8.33%)  0/12 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, PRISE
[1]
Depression
[2]
Cardiopulmonary disorder unrelated to study participation
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Ketamine Midazolam
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   12/12 (100.00%)      12/12 (100.00%)    
Cardiac disorders     
Chest pain  1  0/12 (0.00%)  0 2/12 (16.67%)  2
Eye disorders     
Blurred vision  1  1/12 (8.33%)  1 1/12 (8.33%)  1
Gastrointestinal disorders     
Constipation  1  1/12 (8.33%)  1 1/12 (8.33%)  1
General disorders     
Nausea/Vomiting  1  1/12 (8.33%)  1 3/12 (25.00%)  3
Diarrhea  1  0/12 (0.00%)  0 3/12 (25.00%)  3
Poor concentration  1  2/12 (16.67%)  2 1/12 (8.33%)  1
General malaise  1  2/12 (16.67%)  2 0/12 (0.00%)  0
Restlessness  1  2/12 (16.67%)  2 0/12 (0.00%)  0
Dry mouth  1  0/12 (0.00%)  0 2/12 (16.67%)  2
Difficulty sleeping  1  1/12 (8.33%)  1 1/12 (8.33%)  1
Nervous system disorders     
Headache  1  7/12 (58.33%)  7 3/12 (25.00%)  3
Dizziness on standing  1  2/12 (16.67%)  2 3/12 (25.00%)  3
Poor coordination  1  2/12 (16.67%)  2 0/12 (0.00%)  0
Psychiatric disorders     
Anxiety  1  2/12 (16.67%)  2 2/12 (16.67%)  2
Renal and urinary disorders     
Frequent urination  1  1/12 (8.33%)  1 1/12 (8.33%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, PRISE
Sample size is small, increasing the likelihood of a false negative finding due to limited power. Unknown if the lack of significant separation between the treatment and control conditions at 24 h represents a true null finding or a false negative.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. J. W. Murrough
Organization: Mood and Anxiety Disorders Program, Department of Psychiatry, Icahn School of Medicine at Mount Sinai
Phone: 212-241-7574
Responsible Party: James Murrough, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT01507181     History of Changes
Other Study ID Numbers: GCO 10-1589
First Submitted: January 6, 2012
First Posted: January 10, 2012
Results First Submitted: April 18, 2016
Results First Posted: February 8, 2017
Last Update Posted: February 8, 2017