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Intramuscular Ketamine for Suicidal Ideation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05105061
Recruitment Status : Not yet recruiting
First Posted : November 3, 2021
Last Update Posted : November 3, 2021
Sponsor:
Information provided by (Responsible Party):
Matthew Klein, Icahn School of Medicine at Mount Sinai

Tracking Information
First Submitted Date  ICMJE October 22, 2021
First Posted Date  ICMJE November 3, 2021
Last Update Posted Date November 3, 2021
Estimated Study Start Date  ICMJE November 2021
Estimated Primary Completion Date November 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 22, 2021)
Change in Auditory Mismatch Negativity (EEG) [ Time Frame: Baseline and One hour post injection ]
Change in Mismatch Negativity (MMN) amplitude or latency from baseline up to one hour after injection.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: October 22, 2021)
Change in Montgomery-Asberg Depression Rating Scale (MADRS) #10 (SI) [ Time Frame: Baseline and 24 hours post injection ]
Change in MADRS #10 from baseline to 24 hours post-injection. Score range from 0-5, with higher score indicating higher severity of symptoms.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intramuscular Ketamine for Suicidal Ideation
Official Title  ICMJE Intramuscular Ketamine Administration for the Treatment of Acute Suicidal Ideation With Concurrent EEG Monitoring
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Suicidal Ideation
Intervention  ICMJE
  • Drug: Ketamine (Ketalar)
    0.5 mg/kg of body weight
  • Drug: Placebo
    IM injection of matching placebo
Study Arms  ICMJE
  • Experimental: Ketamine (1) then Placebo (2)
    Participants will receive an intramuscular injection of racemic ketamine, followed the next day by an intramuscular injection of saline (placebo)
    Interventions:
    • Drug: Ketamine (Ketalar)
    • Drug: Placebo
  • Placebo Comparator: Placebo (1) then Ketamine (2)
    Participants will receive an intramuscular injection of saline (placebo), followed the next day by an intramuscular injection of racemic ketamine
    Interventions:
    • Drug: Ketamine (Ketalar)
    • Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: October 22, 2021)
22
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2023
Estimated Primary Completion Date November 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Audrey Evers (212) 585-4623 audrey.evers@mssm.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05105061
Other Study ID Numbers  ICMJE STUDY-20-01496
21-1174 ( Other Identifier: American Foundation for Suicide Prevention )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Time Frame: Beginning 3 months and ending 5 years following article publication.
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.
Responsible Party Matthew Klein, Icahn School of Medicine at Mount Sinai
Study Sponsor  ICMJE Icahn School of Medicine at Mount Sinai
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Matthew Klein Icahn School of Medicine at Mount Sinai
PRS Account Icahn School of Medicine at Mount Sinai
Verification Date October 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP