# Double-Blind Randomized Controlled Trial of Acute-Course of Ketamine Versus Midazolam for Recurrence of Suicidality in Adolescents

> **NIH NIH R01** · UT SOUTHWESTERN MEDICAL CENTER · 2020 · $620,262

## Abstract

PROJECT SUMMARY
Rates of suicide have increased dramatically in youths over the past decade, and suicide is now the 2nd
leading cause of death for individuals ages 15-24. There are no validated treatments to decrease the risk of
adolescent suicidal behavior, and currently available standard treatments are of modest benefit and often take
weeks or months to become effective. Hence, there is an urgent need to identify rapid-acting treatments that
ameliorate symptoms associated with suicidality and prevent repeat suicidal events. Based on evidence for
efficacy of ketamine in reducing symptoms of suicidality in adults, as well as an open label study in
adolescents, ketamine appears to be a promising treatment approach for youths with a recent suicidal event.
We propose to conduct the first randomized, controlled trial of ketamine in youth with recent suicidal behaviors.
All youth will be in treatment in an intensive outpatient program for suicidal adolescents, and will be
randomized to intravenous ketamine 0.5mg/kg or midazolam 0.02mg/kg for four infusions over two weeks
within +/- ten days of starting IOP. We will also examine implicit cognitive associations using the Death/Suicide
Implicit Association Test (IAT). All participants will be followed for 12 weeks to evaluate: 1) reduction in repeat
suicide attempts over 12 weeks, 2) reduction in implicit suicidal cognition within the 2-week study treatment
period, and 3) reduction in depression and suicidal ideation within the 2-week study period. We will also
explore whether reductions in IAT mediates improvement in suicidality over 12 weeks. To date, no study has
reported evidence for 1) reduction in repeat suicidal events with ketamine either in adults or in youths (AIM 1),
2) reductions either in implicit cognition (AIM 2) or in symptoms associated with suicidality (AIM 3) in youths,
and 3) underlying mechanisms that mediate (AIM 4) the effects of ketamine on suicidality. Innovative features
include: 1) it targets repeat suicidal events during a high-risk period in high-risk youths who are typically
excluded from clinical trials; 2) is transdiagnostic; 3) seamlessly integrates in current standard of care; and 4)
evaluates an intervention that can be delivered at a time and place when there is greatest clinical need, but for
which there are no currently developed interventions.

## Key facts

- **NIH application ID:** 10114915
- **Project number:** 1R01MH125181-01
- **Recipient organization:** UT SOUTHWESTERN MEDICAL CENTER
- **Principal Investigator:** MADHUKAR H. TRIVEDI
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $620,262
- **Award type:** 1
- **Project period:** 2020-09-15 → 2024-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10114915

## Citation

> US National Institutes of Health, RePORTER application 10114915, Double-Blind Randomized Controlled Trial of Acute-Course of Ketamine Versus Midazolam for Recurrence of Suicidality in Adolescents (1R01MH125181-01). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10114915. Licensed CC0.

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