Intramuscular Ketamine for Suicidal Ideation
Primary Purpose
Suicidal Ideation
Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Ketamine (Ketalar)
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Suicidal Ideation focused on measuring Suicide, EEG, Ketamine
Eligibility Criteria
Inclusion Criteria:
- Current clinically significant suicidal ideation, defined as a score of > or = 4 on the MADRS item 10 and a positive answer on items 3,4 or 5 of the C-SSRS.
- Inpatient status at the time of study initiation.
- 18 to 70 years of age
- Capacity to consent
Exclusion criteria:
- Diagnosis of a primary psychotic disorder (e.g., schizoaffective disorder)
- Diagnosis of pervasive developmental disorder
- Diagnosis of a major neurocognitive disorder
- A positive urine pregnancy test
- Currently breastfeeding
- Drug or alcohol abuse or dependence within the preceding 3 months; a rather narrow time period was chosen, however, in order to allow participation by individuals with a history of substance abuse or dependence problems that could be secondary to their SI, and to more closely approximate patients seen in real-world settings. Given the increasingly widespread use of marijuana, and in an effort to recruit a naturalistic study population, concurrent marijuana use is not an exclusion criterion, as long as they are not actively intoxicated.
- Current positive UTOX for amphetamine, benzodiazepines, cocaine, opiates (if not prescribed)
- Medical issues or laboratory abnormalities requiring acute intervention
- Patients for whom an increase in blood pressure or intracranial pressure would pose a serious risk (e.g., aneurysmal vascular disease, arteriovenous malformation, history of intracerebral hemorrhage, unstable angina)
- Any lifetime history of ketamine or phencyclidine abuse
- A known hypersensitivity to or history of a serious adverse effect from to ketamine
Sites / Locations
- Icahn School of Medicine at Mount Sinai
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Ketamine (1) then Placebo (2)
Placebo (1) then Ketamine (2)
Arm Description
Participants will receive an intramuscular injection of racemic ketamine, followed the next day by an intramuscular injection of saline (placebo)
Participants will receive an intramuscular injection of saline (placebo), followed the next day by an intramuscular injection of racemic ketamine
Outcomes
Primary Outcome Measures
Change in Auditory Mismatch Negativity (EEG)
Change in Mismatch Negativity (MMN) amplitude or latency from baseline up to one hour after injection.
Secondary Outcome Measures
Change in Montgomery-Asberg Depression Rating Scale (MADRS) #10 (SI)
Change in MADRS #10 from baseline to 24 hours post-injection. Score range from 0-5, with higher score indicating higher severity of symptoms.
Full Information
NCT ID
NCT05105061
First Posted
October 22, 2021
Last Updated
March 24, 2022
Sponsor
Icahn School of Medicine at Mount Sinai
1. Study Identification
Unique Protocol Identification Number
NCT05105061
Brief Title
Intramuscular Ketamine for Suicidal Ideation
Official Title
Intramuscular Ketamine Administration for the Treatment of Acute Suicidal Ideation With Concurrent EEG Monitoring
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Withdrawn
Why Stopped
PI leaving institution
Study Start Date
February 2022 (Anticipated)
Primary Completion Date
March 24, 2022 (Actual)
Study Completion Date
March 24, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Icahn School of Medicine at Mount Sinai
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The objective of the present research protocol, a cross-over, subject-blinded, clinical trial, is to correlate changes in brain activity with reduction in suicidal ideation in response to a single intramuscular dose of ketamine. While ketamine is increasingly used as a rapid, antidepressant agent, there is accumulating evidence of additional anti-suicidal properties that may be distinct from its effects on depression. This pilot study will be used to determine (1) whether specific electroencephalogram (EEG) findings are correlated with response of SI to intramuscular (IM) ketamine, and (2) the effectiveness of IM ketamine in the treatment of acute SI.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicidal Ideation
Keywords
Suicide, EEG, Ketamine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ketamine (1) then Placebo (2)
Arm Type
Experimental
Arm Description
Participants will receive an intramuscular injection of racemic ketamine, followed the next day by an intramuscular injection of saline (placebo)
Arm Title
Placebo (1) then Ketamine (2)
Arm Type
Placebo Comparator
Arm Description
Participants will receive an intramuscular injection of saline (placebo), followed the next day by an intramuscular injection of racemic ketamine
Intervention Type
Drug
Intervention Name(s)
Ketamine (Ketalar)
Intervention Description
0.5 mg/kg of body weight
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
IM injection of matching placebo
Primary Outcome Measure Information:
Title
Change in Auditory Mismatch Negativity (EEG)
Description
Change in Mismatch Negativity (MMN) amplitude or latency from baseline up to one hour after injection.
Time Frame
Baseline and One hour post injection
Secondary Outcome Measure Information:
Title
Change in Montgomery-Asberg Depression Rating Scale (MADRS) #10 (SI)
Description
Change in MADRS #10 from baseline to 24 hours post-injection. Score range from 0-5, with higher score indicating higher severity of symptoms.
Time Frame
Baseline and 24 hours post injection
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Current clinically significant suicidal ideation, defined as a score of > or = 4 on the MADRS item 10 and a positive answer on items 3,4 or 5 of the C-SSRS.
Inpatient status at the time of study initiation.
18 to 70 years of age
Capacity to consent
Exclusion criteria:
Diagnosis of a primary psychotic disorder (e.g., schizoaffective disorder)
Diagnosis of pervasive developmental disorder
Diagnosis of a major neurocognitive disorder
A positive urine pregnancy test
Currently breastfeeding
Drug or alcohol abuse or dependence within the preceding 3 months; a rather narrow time period was chosen, however, in order to allow participation by individuals with a history of substance abuse or dependence problems that could be secondary to their SI, and to more closely approximate patients seen in real-world settings. Given the increasingly widespread use of marijuana, and in an effort to recruit a naturalistic study population, concurrent marijuana use is not an exclusion criterion, as long as they are not actively intoxicated.
Current positive UTOX for amphetamine, benzodiazepines, cocaine, opiates (if not prescribed)
Medical issues or laboratory abnormalities requiring acute intervention
Patients for whom an increase in blood pressure or intracranial pressure would pose a serious risk (e.g., aneurysmal vascular disease, arteriovenous malformation, history of intracerebral hemorrhage, unstable angina)
Any lifetime history of ketamine or phencyclidine abuse
A known hypersensitivity to or history of a serious adverse effect from to ketamine
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew Klein
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
Facility Information:
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
IPD Sharing Time Frame
Beginning 3 months and ending 5 years following article publication.
IPD Sharing Access Criteria
Researchers who provide a methodologically sound proposal. Any purpose. Proposals may be submitted up to 36 months following article publication. After 36 months the data will be available in our University's data warehouse but without investigator support other than deposited metadata. Information regarding submitting proposals and accessing data will be made available the completion of the study.
Learn more about this trial
Intramuscular Ketamine for Suicidal Ideation
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