Ketamine Versus Midazolam for Recurrence of Suicidality in Adolescents
- Conditions
- Suicide, AttemptedSuicide and DepressionSuicide Threat
- Interventions
- Registration Number
- NCT04592809
- Lead Sponsor
- University of Texas Southwestern Medical Center
- Brief Summary
This project aims to examine the signal of efficacy of ketamine, a rapidly acting medication shown to decrease suicidality in adults in as short as hours or days, as opposed to weeks.
The study design is a double-blind, randomized, active-control trial of adolescents (ages 13-18 years) with recent suicidal behaviors (suicide attempt or increased suicidal ideation). All participants must be receiving standard of care treatment which may range broadly from both outpatient and inpatient programs which include clinically indicated psychosocial and/or psychopharmacological treatments. Ketamine/midazolam treatment will occur twice weekly during the first two weeks of the study, followed by weekly assessments through week 12.
- Detailed Description
Adolescent patients (ages 13-18) who have recent suicidality (defined as suicide attempt or urgent evaluation for a suicidal ideation or behavior), and who are receiving standard of care treatment (e.g., psychosocial and/or psychopharmacological treatment) will be recruited for participation in the study. Upon informed consent/assent, screening data will be collected regarding mood symptoms, suicidal ideation and behavior, associated comorbidities, and treatment history. Youth participants will be randomized to receive infusions of either ketamine or midazolam, which will be provided twice weekly for two weeks. Participants will then have follow-up assessments visits through week 12 to continue to monitoring outcome measures.
Participants may be recruited directly from their standard care outpatient provider, SPARC Intensive Outpatient Program (IOP) located at Children's Health Medical Center, from the Children's Health Emergency Department (ED) or inpatient psychiatric unit located at the Dallas campus. Participants may also be recruited into the study even if they are seen in the in emergency departments or inpatient hospitalization outside of University of Texas (UT) Southwestern and Children's Health Medical Center. Recruitment and consent procedures may begin during ED or inpatient hospitalization; however, as the study is an outpatient study, study procedures will not begin until the participant is discharged from the ED or inpatient hospital.
Recruitment efforts will target medically healthy male and female youths with recent suicide events who are either seeking care at an emergency room, admitted to an inpatient unit, enrolled in an IOP, or receiving adequate outpatient care with either psychopharmacological or psychosocial treatment following a suicide event.
Enrollment of 114 subjects is expected to take place over a period of approximately 36 months. Enrolled participants will be involved in the study for approximately 14 weeks. Visits include a Screening Visit, 4 Study Intervention Visits, and 11 Follow-Up Visits (combination of in-person and remote visits). Multiple streams of outcome measures will be utilized for this protocol, including self-report measures, research assessor-completed measures, clinic level measures, and behavioral measures.
Aim 1. Evaluate reduction in repeat suicidal events with ketamine.
Aim 2. Evaluate reduction in implicit suicidal cognition with ketamine.
Aim 3. Evaluate reduction in depressive symptoms and suicidality with ketamine.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 114
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Ketamine Ketamine Hydrochloride 0.5 mg/kg intravenous ketamine will be administered 4 times in a 2 week period. Ketamine will be dissolved in 0.9% sodium chloride in a total volume of 100ml and administered with a syringe infusion pump at a constant rate. Ketamine Midazolam Hydrochloride 0.5 mg/kg intravenous ketamine will be administered 4 times in a 2 week period. Ketamine will be dissolved in 0.9% sodium chloride in a total volume of 100ml and administered with a syringe infusion pump at a constant rate. Midazolam Midazolam Hydrochloride 0.02 mg/kg midazolam will be administered 4 times in a 2 week period. Midazolam will be dissolved in 0.9% sodium chloride in a total volume of 100ml and administered with a syringe infusion pump at a constant rate. Midazolam Ketamine Hydrochloride 0.02 mg/kg midazolam will be administered 4 times in a 2 week period. Midazolam will be dissolved in 0.9% sodium chloride in a total volume of 100ml and administered with a syringe infusion pump at a constant rate.
- Primary Outcome Measures
Name Time Method The primary outcome for the study is "suicidal events". Suicidal event is defined as a suicide attempt, or emergency department visit or inpatient hospitalization due to suicidality. 12 weeks Concise Health Risk Tracking Clinician-Rated Behavior Module (CHRT-C) will be used to identify suicidal events. The CHRT-C consists of nine clinician-rated yes/no items about specific behaviors (i.e., suicidal ideation, suicidal attempt, preparatory acts, non-suicidal self-injury (NSSI), other injuries, etc.). At the initial administration, this instrument captures lifetime information; at subsequent administrations, it will capture information since the last visit.
- Secondary Outcome Measures
Name Time Method Death/Suicide Implicit Association Test (IAT) 2 weeks The IAT is a performance-based measure of cognition that has demonstrated good reliability and sensitivity to change. The IAT measures associations based on response latency where the response time is compared across categorization tasks.
Depression symptoms as measured by CHRT-SR a self report measure 2 weeks (specify for each) Concise Health Risk Tracking Self-Report (CHRT-SR) consists of 14 questions with responses ranging from 0 (strongly disagree) to 4 (strongly agree). 1) the Propensity subscale, which consists of 9 questions and 4 factors (pessimism, helplessness, social support, and despair) and a score range of 0-36; and the Suicidal Thoughts subscale, which consists of 3 questions and a score range of 0-9 (which will serve as the primary suicidal behavior outcome in this study); and 3) Impulsivity, which consists of 2 questions and a score range of 0-6. A total score is also calculated, ranging from 0 to 56.
Number of participants with suicidal events/behaviors as measured by CHRT-C a self report measure 2 week Concise Health Risk Tracking Clinician-Rated Behavior Module (CHRT-C). consists of nine clinician-rated yes/no items about specific behaviors (i.e., suicidal ideation, suicidal attempt, preparatory acts, non-suicidal self-injury (NSSI), other injuries, etc.). At the initial administration, this instrument captures lifetime information; at subsequent administrations, it will capture information since the last visit. a yes on any of the 9 questions indicates presence of suicidal event/behaviors (ideation, attempt, preparatory acts, non suicidal self injury, other injury).
Depression symptoms as measured by the Inventory of Depressive Symptomatology (IDS), self-report measure 2 weeks The Inventory of Depressive Symptomatology (IDS) Self Report is a depressive symptom severity measure that rates all nine criterion symptoms of MDD, and includes an irritability item for adolescents. The self report (IDS-SR) will be completed at each visit.
Trial Locations
- Locations (1)
UT Southwestern Medical Center
🇺🇸Dallas, Texas, United States