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Ketamine for Suicidality in Bipolar Depression

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ClinicalTrials.gov Identifier: NCT01944293
Recruitment Status : Completed
First Posted : September 17, 2013
Results First Posted : June 6, 2019
Last Update Posted : March 11, 2020
Sponsor:
Collaborator:
Brain & Behavior Research Foundation
Information provided by (Responsible Party):
Michael Grunebaum, MD, New York State Psychiatric Institute

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Bipolar Disorder
Major Depressive Episode
Suicidal Ideation
Interventions Drug: Ketamine
Drug: Midazolam
Enrollment 16
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Ketamine Midazolam
Hide Arm/Group Description

0.5 mg/kg, I.V. (in the vein)

Ketamine: Single dose of 0.5 mg/kg of Ketamine given intravenously (in the vein) over 40 minutes

0.02 mg/kg, I.V. (in the vein)

Ketamine: Single dose of 0.5 mg/kg of Ketamine given intravenously (in the vein) over 40 minutes

Midazolam: Single dose of 0.02 mg/kg of Midazolam given intravenously (in the vein) over 40 minutes

Period Title: Overall Study
Started 7 9
Completed 7 9
Not Completed 0 0
Arm/Group Title Ketamine Midazolam Total
Hide Arm/Group Description

0.5 mg/kg, I.V. (in the vein)

Ketamine: Single dose of 0.5 mg/kg of Ketamine given intravenously (in the vein) over 40 minutes

0.02 mg/kg, I.V. (in the vein)

Ketamine: Single dose of 0.5 mg/kg of Ketamine given intravenously (in the vein) over 40 minutes

Midazolam: Single dose of 0.02 mg/kg of Midazolam given intravenously (in the vein) over 40 minutes

Total of all reporting groups
Overall Number of Baseline Participants 7 9 16
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 7 participants 9 participants 16 participants
39  (10.2) 43  (13.9) 40.5  (12.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 9 participants 16 participants
Female
3
  42.9%
7
  77.8%
10
  62.5%
Male
4
  57.1%
2
  22.2%
6
  37.5%
Race/Ethnicity, Customized   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 9 participants 16 participants
More than one race
1
  14.3%
0
   0.0%
1
   6.3%
White race
6
  85.7%
8
  88.9%
14
  87.5%
Not Hispanic
7
 100.0%
8
  88.9%
15
  93.8%
Hispanic
0
   0.0%
1
  11.1%
1
   6.3%
Asian
0
   0.0%
1
  11.1%
1
   6.3%
[1]
Measure Description: Race/Ethnicity, Customized: Non-white
Beck Scale for Suicidal Ideation (Clinician-rated)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 7 participants 9 participants 16 participants
16.7  (8.4) 16.8  (6.0) 16.8  (6.9)
[1]
Measure Description: This scale has 19 items scaled 0 (least severe) to 2 (most severe) with a potential score total range of 0 to 38 measuring severity of suicidal thoughts.
1.Primary Outcome
Title Change in Suicidal Ideation Measured With the Beck Scale for Suicidal Ideation
Hide Description Change in suicidal ideation in Bipolar Disorder during a Major Depressive Episode (MDE), with moderate to severe suicidal thoughts, from the pre-infusion baseline to 24 hours after the infusion of Ketamine (study drug) or Midazolam (active control).
Time Frame At 24 hours post-Infusion
Hide Outcome Measure Data
Hide Analysis Population Description
Bipolar depression with suicidal ideation.
Arm/Group Title Ketamine Midazolam
Hide Arm/Group Description:

0.5 mg/kg, I.V. (in the vein)

Ketamine: Single dose of 0.5 mg/kg of Ketamine given intravenously (in the vein) over 40 minutes

0.02 mg/kg, I.V. (in the vein)

Ketamine: Single dose of 0.5 mg/kg of Ketamine given intravenously (in the vein) over 40 minutes

Midazolam: Single dose of 0.02 mg/kg of Midazolam given intravenously (in the vein) over 40 minutes

Overall Number of Participants Analyzed 7 9
Mean (Standard Deviation)
Unit of Measure: units on a scale
-12.4  (11.6) -6.7  (7.4)
2.Secondary Outcome
Title Change in Systolic Blood Pressure
Hide Description Blood pressure is measured in millimeters of mercury.
Time Frame During study infusion
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ketamine Midazolam
Hide Arm/Group Description:

0.5 mg/kg, I.V. (in the vein)

Ketamine: Single dose of 0.5 mg/kg of Ketamine given intravenously (in the vein) over 40 minutes

0.02 mg/kg, I.V. (in the vein)

Ketamine: Single dose of 0.5 mg/kg of Ketamine given intravenously (in the vein) over 40 minutes

Midazolam: Single dose of 0.02 mg/kg of Midazolam given intravenously (in the vein) over 40 minutes

Overall Number of Participants Analyzed 7 9
Mean (Standard Deviation)
Unit of Measure: mm Hg
23  (12.8) 3  (10.2)
Time Frame 6 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ketamine Midazolam
Hide Arm/Group Description

0.5 mg/kg, I.V. (in the vein)

Ketamine: Single dose of 0.5 mg/kg of Ketamine given intravenously (in the vein) over 40 minutes

0.02 mg/kg, I.V. (in the vein)

Ketamine: Single dose of 0.5 mg/kg of Ketamine given intravenously (in the vein) over 40 minutes

Midazolam: Single dose of 0.02 mg/kg of Midazolam given intravenously (in the vein) over 40 minutes

All-Cause Mortality
Ketamine Midazolam
Affected / at Risk (%) Affected / at Risk (%)
Total   0/7 (0.00%)      0/9 (0.00%)    
Hide Serious Adverse Events
Ketamine Midazolam
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/7 (57.14%)      0/9 (0.00%)    
Psychiatric disorders     
Increased suicidal thoughts requiring hospitalization   2/7 (28.57%)  4 0/9 (0.00%)  0
suicide attempt   1/7 (14.29%)  1 0/9 (0.00%)  0
Preparatory suicidal behavior   1/7 (14.29%)  1 0/9 (0.00%)  0
Indicates events were collected by systematic assessment
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   0/7 (0.00%)      0/9 (0.00%)    
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Michael Grunebaum, MD
Organization: Columbia University Medical Center - NY State Psychiatric Institute
Phone: 646-774-7573
EMail: michael.grunebaum@nyspi.columbia.edu
Layout table for additonal information
Responsible Party: Michael Grunebaum, MD, New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT01944293    
Other Study ID Numbers: #6785
First Submitted: September 8, 2013
First Posted: September 17, 2013
Results First Submitted: October 3, 2018
Results First Posted: June 6, 2019
Last Update Posted: March 11, 2020