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Ketamine & Crisis Response Plan for Suicidal Ideation in the ED

Primary Purpose

Suicide

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Ketamine Hydrochloride
Crisis Response Plan
Sponsored by
The University of Texas Health Science Center at San Antonio
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Suicide focused on measuring Ketamine, Crisis Response Plan, Suicidal Ideation, Emergency Department, Acute Suicidality, Intramuscular Ketamine, Emergency Room

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Adult men and women between the ages of 18 and 70 presenting to the Emergency Department with acute suicidal ideation. Patient cleared for admission to the University Hospital inpatient psychiatric unit. Decision to admit the patient to the inpatient unit or psychiatric stabilization unit made prior to consent to prevent study procedures from complicating or influencing the disposition and treatment as usual for suicidal patients reporting to the ED. Individuals presenting to the ED for other complaints but found to have suicidal ideation necessitating admission will also be eligible. Able to read and write English. Exclusion Criteria: Serious mental illness with active and significant signs of psychosis, mania, hallucinations, paranoia, agitation, and drug-induced or other toxidromic symptoms. Acute intoxication with clinically significant symptoms (as defined by the attending clinician's assessment of patients' clinical sobriety). The patient is not capable of understanding the research procedures and providing informed consent for themselves. Lack of reliable means to be available for follow-up assessments (e.g, working mobile phone). Persistent resting blood pressure lower than 90/60 or higher than 180/110, or persistent resting heart rate lower than 45 beats/minute or higher than 120 beats/minute. Injuries requiring procedural sedation. Pregnancy or breast feeding. Known hypersensitivity to ketamine. Legal or illegal use of ketamine in the previous 90 days. End-stage or severe cardiovascular (e.g., ACS or decompensated heart failure), liver, or kidney disease. Patient is a prisoner. Patient is physically restrained or actively under custody of law enforcement. Once a patient is no longer under custody of law enforcement or physically restrained, the patient may be considered eligible and may consent to voluntary enrollment in the study.

Sites / Locations

  • University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Ketamine and Crisis Response Plan (CRP)

Treatment as Usual

Arm Description

Individuals randomized to the experimental arm will receive 100mg intramuscular ketamine injection before completing the Crisis Response Plan. The average timeframe for the experimental arm is anticipated to be approximately 60 minutes of active treatment. Following ketamine administration, the subject will be monitored for 45 minutes with pulse oximetry and recurrent vital signs. The study team will record when the CRP is completed in relation to the ketamine injection.

Individuals randomized to the no intervention arm will receive routine care from emergency providers and psychiatry staff.

Outcomes

Primary Outcome Measures

Feasibility of study interventions
Number of enrolled subjects completing treatment within study parameters, with safety and side-effect profiles at or lower than published rates.

Secondary Outcome Measures

Change in Beck Scale for Suicidal Ideation (SSI) Score
The Beck Scale for Suicidal Ideation (SSI) is a 21-item measurement that evaluates the presence and intensity of suicidal thoughts. Each item is scored on a scale from 0-2 with a total score of 0-38; with higher scores indicating higher levels of suicidal ideation.
Change in Depressive Symptoms Index-Suicidality Subscale (DSI-SS) Score
The Depressive Symptoms Index-Suicidality Subscale (DSI-SS) is a 4-item measure of suicidal ideation. Respondents rate each item on a 4-point scale ranging from 0-3. Responses are summed, and higher scores reflect more severe suicidal ideation (range: 0-12).
Change in Suicide Visual Analog Scale (S-VAS) Score
The Suicide Visual Analog Scale is a 1-item momentary assessment to evaluate severity of suicidal ideation. The item is scored from 0-100 and the total possible score range for the scale is therefore also 0-100. Lower scores indicate less extreme current urges toward self harm, whereas higher scores are indicative of more severe urges.

Full Information

First Posted
January 12, 2023
Last Updated
February 8, 2023
Sponsor
The University of Texas Health Science Center at San Antonio
Collaborators
National Center for Advancing Translational Sciences (NCATS)
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1. Study Identification

Unique Protocol Identification Number
NCT05696691
Brief Title
Ketamine & Crisis Response Plan for Suicidal Ideation in the ED
Official Title
A Randomized Pilot Trial of Intramuscular Ketamine and Crisis Response Planning for Suicide Prevention in the Emergency Department
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 6, 2023 (Actual)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Texas Health Science Center at San Antonio
Collaborators
National Center for Advancing Translational Sciences (NCATS)

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
No

5. Study Description

Brief Summary
The goal of this randomized pilot trial is to assess the feasibility of administering a combination of 100mg intramuscular (IM) ketamine and Crisis Response Plan (a short psychosocial intervention) for patients with acute suicidality in the context of the Emergency Department setting. This study will assess a combination of a pharmacologic intervention and a psychosocial one. The pharmacologic intervention is a one-time dose of 100mg ketamine delivered intramuscularly (IM) while the patient is in the ED. The psychosocial intervention under study is a brief, patient-centered therapy which takes, on average, 30 minutes to administer. Both interventions will be administered only once. The main questions this study aims to answer are: Determine if 100mg of IM ketamine and Crisis Response Plan in combination results in greater short-term reductions in suicidal ideation in adult patients who report acutely elevated suicide risk during an ED visit. Examine potential weight-based dose response differences in the reductions in suicidal ideation to determine if future treatment protocols with IM ketamine may benefit from weight-based dosing.
Detailed Description
This study is a phase II/III Clinical Pilot Trial. The study participants will be randomized to one of two groups: IM ketamine plus Crisis Response Planning (intervention group) or usual care (control group). Prior to treatment, we will obtain demographic and contact information for patients and for a friend/family member as a collateral reporter of symptom change and safety. As part of informed consent, participants will be warned about the potential for temporary effects of ketamine and provided an enrollment card to inform other care providers of their participation in a ketamine study. Participants will be weighed and complete a series of brief survey assessments. Clinical assessments such as history, physical examination, and routine laboratory testing will be collected as part of usual care. Ketamine and Crisis Response Planning will be administered, and study assessments will be repeated at 120 minutes posttreatment. To ensure the highest level of patient safety, we are proposing only to include patients who have already been cleared for a psychiatric hospitalization. This will also allow for close monitoring of symptom changes during the initial hours and days following treatment. Outcome measures will be collected at two hours, 3 days, and 1 month after the intervention. Research staff will collect assessments by telephone interview and/or visits. Consistent with established protocols, staff will be trained and supervised by STRONG STAR mental health professionals with expertise in evidence-based processes for assessing and responding to suicide risk. Trained and experienced therapists are available to meet with participants to develop a Crisis Response Plan at University Hospital.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicide
Keywords
Ketamine, Crisis Response Plan, Suicidal Ideation, Emergency Department, Acute Suicidality, Intramuscular Ketamine, Emergency Room

7. Study Design

Primary Purpose
Other
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ketamine and Crisis Response Plan (CRP)
Arm Type
Experimental
Arm Description
Individuals randomized to the experimental arm will receive 100mg intramuscular ketamine injection before completing the Crisis Response Plan. The average timeframe for the experimental arm is anticipated to be approximately 60 minutes of active treatment. Following ketamine administration, the subject will be monitored for 45 minutes with pulse oximetry and recurrent vital signs. The study team will record when the CRP is completed in relation to the ketamine injection.
Arm Title
Treatment as Usual
Arm Type
No Intervention
Arm Description
Individuals randomized to the no intervention arm will receive routine care from emergency providers and psychiatry staff.
Intervention Type
Drug
Intervention Name(s)
Ketamine Hydrochloride
Other Intervention Name(s)
Ketamine
Intervention Description
100mg IM ketamine to be administered in conjunction with CRP. The ketamine injection will be administered first. Participants will be observed and have vital signs monitored for the first 45 minutes after administering medication in the ED, observing for immediate reactions. Afterwards, participants will continue to be monitored for potential late-term side effects on the inpatient unit. Ketamine will be given only after initial standard of care (SOC) treatment and screening studies have been initiated.
Intervention Type
Behavioral
Intervention Name(s)
Crisis Response Plan
Other Intervention Name(s)
CRP
Intervention Description
Crisis Response Plan is a brief, empirically-validated, Cognitive-Behavioral Therapy-based one-time therapy, and its administration typically takes 30-60 minutes. It begins with a narrative assessment (allowing patients to "tell their story") and concludes with collaboratively constructed plan that outlines strategies for the patient's self-management of future acute suicidal crises. Patients who engage in CRP are given an index card to keep with them that summarizes the emotional management strategies that they collaboratively generate with the CRP provider.
Primary Outcome Measure Information:
Title
Feasibility of study interventions
Description
Number of enrolled subjects completing treatment within study parameters, with safety and side-effect profiles at or lower than published rates.
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Change in Beck Scale for Suicidal Ideation (SSI) Score
Description
The Beck Scale for Suicidal Ideation (SSI) is a 21-item measurement that evaluates the presence and intensity of suicidal thoughts. Each item is scored on a scale from 0-2 with a total score of 0-38; with higher scores indicating higher levels of suicidal ideation.
Time Frame
Baseline to 30 days
Title
Change in Depressive Symptoms Index-Suicidality Subscale (DSI-SS) Score
Description
The Depressive Symptoms Index-Suicidality Subscale (DSI-SS) is a 4-item measure of suicidal ideation. Respondents rate each item on a 4-point scale ranging from 0-3. Responses are summed, and higher scores reflect more severe suicidal ideation (range: 0-12).
Time Frame
Baseline to 30 days
Title
Change in Suicide Visual Analog Scale (S-VAS) Score
Description
The Suicide Visual Analog Scale is a 1-item momentary assessment to evaluate severity of suicidal ideation. The item is scored from 0-100 and the total possible score range for the scale is therefore also 0-100. Lower scores indicate less extreme current urges toward self harm, whereas higher scores are indicative of more severe urges.
Time Frame
Baseline to 30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Adult men and women between the ages of 18 and 70 presenting to the Emergency Department with acute suicidal ideation. Patient cleared for admission to the University Hospital inpatient psychiatric unit. Decision to admit the patient to the inpatient unit or psychiatric stabilization unit made prior to consent to prevent study procedures from complicating or influencing the disposition and treatment as usual for suicidal patients reporting to the ED. Individuals presenting to the ED for other complaints but found to have suicidal ideation necessitating admission will also be eligible. Able to read and write English. Exclusion Criteria: Serious mental illness with active and significant signs of psychosis, mania, hallucinations, paranoia, agitation, and drug-induced or other toxidromic symptoms. Acute intoxication with clinically significant symptoms (as defined by the attending clinician's assessment of patients' clinical sobriety). The patient is not capable of understanding the research procedures and providing informed consent for themselves. Lack of reliable means to be available for follow-up assessments (e.g, working mobile phone). Persistent resting blood pressure lower than 90/60 or higher than 180/110, or persistent resting heart rate lower than 45 beats/minute or higher than 120 beats/minute. Injuries requiring procedural sedation. Pregnancy or breast feeding. Known hypersensitivity to ketamine. Legal or illegal use of ketamine in the previous 90 days. End-stage or severe cardiovascular (e.g., ACS or decompensated heart failure), liver, or kidney disease. Patient is a prisoner. Patient is physically restrained or actively under custody of law enforcement. Once a patient is no longer under custody of law enforcement or physically restrained, the patient may be considered eligible and may consent to voluntary enrollment in the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alexander P Hood
Phone
2014505387
Email
hooda1@uthscsa.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert De Lorenzo, MD, MSM
Organizational Affiliation
UT Health San Antonio
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Romeo Fairley, MD, MPH
Organizational Affiliation
UT Health San Antonio
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Alan Peterson, PhD, ABPP
Organizational Affiliation
UT Health San Antonio
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Stacey Young-McCaughan, RN, PhD
Organizational Affiliation
UT Health San Antonio
Official's Role
Study Director
Facility Information:
Facility Name
University Hospital
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert DeLorenzo, MD
Phone
210-567-4292
Email
delorenzo@uthscsa.edu
First Name & Middle Initial & Last Name & Degree
Robert A De Lorenzo, MD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
All collected de-identified participant data that underlie results in a publication will be shared in a peer-reviewed scientific publication once data analysis is complete.
IPD Sharing Time Frame
Data will be made available upon conclusion of the study and dissemination of findings. It will be made available for five (5) years after the conclusion of the study.
IPD Sharing Access Criteria
Links to study documents and data will be shared on website following publication of study results to enable the creation and refinement of related projects' study design and procedures.

Learn more about this trial

Ketamine & Crisis Response Plan for Suicidal Ideation in the ED

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