Randomized controlled trial of acute ketamine versus midazolam for recurrence of suicidality in adolescents (TASK): Rationale, design, and baseline characteristics.
Madhukar H. Trivedi, Cherise R Chin Fatt, Emine Rabia Ayvaci, Taryn L Mayes, Manish K. Jha, Thomas K Pak, Sarah Rebstock, Thomas Spain, Deryk Walsh, Stephen Kimatian, Maria Monastirsky, Srividya Vasu, Thomas J Carmody, Abu Minhajuddin, Betsy D Kennard, Graham J Emslie
Contemporary Clinical Trials October 8, 2026 DOI: 10.1016/j.cct.2026.108498 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Randomized controlled trial Double-blind Peer reviewed |
|---|---|
| Sample size | 50 |
| Population | Adolescents aged 13-18 years with recent suicidal events |
| Interventions | Ketamine Midazolam |
| Dose | ketamine 0.5 mg/kg; midazolam 0.02 mg/kg |
| Duration | Four infusions during the first two weeks (days 0, 3, 7, 10); follow-up through week 12 |
| Topics | Esketamine Ketamine |
| Keywords | Adolescents Intravenous ketamine Randomized controlled trial Suicidality Task |
| Registration | NCT04592809 |
| Key findings | The report describes the design of the TASK trial and its baseline cohort rather than trial outcomes. The randomized sample of 50 adolescents was 82% female and 64% White, with a mean age of 15.4 years, an average of three lifetime suicide attempts, 74% with moderate to severe depression, and 54% with moderate to severe anxiety. The authors state that TASK findings may inform the use of ketamine to reduce suicidal events in youths. |
Abstract
Suicide is one of the leading causes of death among adolescents in the United States. The 'Acute Course of Ketamine Versus Midazolam for Recurrence of Suicidality in Adolescents' (TASK), a double-blind, randomized, controlled trial, was designed to examine the signal for efficacy of ketamine, compared to midazolam (active control), in reducing 1) repeat suicidal events, 2) implicit cognition, and 3) depression symptoms and suicidal thoughts and behaviors in adolescents (ages 13-18 years) with recent suicidal events. The report describes the study rationale and design, and the baseline cohort characteristics. Participants were randomized (1:1) to receive either intravenous ketamine (0.5 mg/kg) or midazolam (0.02 mg/kg) for four infusions during the first two weeks (days 0, 3, 7, 10). Participants completed follow-up assessment visits weekly through week 12 (twice weekly during the first two weeks) to monitor outcomes. Of the 70 participants who consented/assented to screening, 55 were deemed eligible, and 50 were randomized to ketamine or midazolam. The participants were 82% female and 64% White, with a mean age of 15.4 years (SD = 1.6). On average, the adolescents had three lifetime suicide attempts (SD = 2), two inpatient hospitalizations for lifetime suicidal ideation (SD = 2), and one lifetime emergency evaluation for suicidal ideation (SD = 1). Approximately three out of four youth (74%) reported moderate to severe depression, and 54% reported moderate to severe anxiety. TASK study findings may inform the use of ketamine to reduce suicidal events in youths with recent suicidal events. Clinical Trial Registration: The trial is registered with ClinicalTrials.gov (NCT04592809; date of registration - 10.19.2020).
Comparable studies
Other randomized controlled trials on ketamine, most cited first.
| Study | Year | Design | Participants |
|---|---|---|---|
| Subanesthetic Effects of the Noncompetitive NMDA Antagonist, Ketamine, in Humans Healthy human subjects recruited from the community | 1994 | Randomized controlled trial | n = 19 |
| Antidepressant Efficacy of Ketamine in Treatment-Resistant Major Depression: A Two-Site Randomized Controlled Trial Patients with treatment-resistant major depression experiencing a major depressive episode | 2013 | Randomized controlled trial | n = 73 |
| Remifentanil-induced Postoperative Hyperalgesia and Its Prevention with Small-dose Ketamine Patients undergoing major abdominal surgery | 2005 | Randomized controlled trial | n = 75 |
| Efficacy of Intravenous Ketamine for Treatment of Chronic Posttraumatic Stress Disorder Patients with chronic PTSD related to a range of trauma exposures | 2014 | Randomized controlled trial | n = 41 |
| Ketamine-Induced Deficits in Auditory and Visual Context-Dependent Processing in Healthy Volunteers Healthy volunteers | 2000 | Single-blind placebo-controlled study | n = 20 |
Citations in the library
Cites 11
- Efficacy of Esketamine Nasal Spray Plus Oral Antidepressant Treatment for Relapse Prevention in Patients With Treatment-Resistant Depression JAMA Psychiatry June 5, 2019
- Synthesizing the Evidence for Ketamine and Esketamine in Treatment-Resistant Depression: An International Expert Opinion on the Available Evidence and Implementation American Journal of Psychiatry March 17, 2021
- The effect of a single dose of intravenous ketamine on suicidal ideation: a systematic review and individual participant data meta-analysis American Journal of Psychiatry October 3, 2017
- EFFECTS OF KETAMINE ON EXPLICIT AND IMPLICIT SUICIDAL COGNITION: A RANDOMIZED CONTROLLED TRIAL IN TREATMENT-RESISTANT DEPRESSION Depression and Anxiety March 25, 2014
- Ketamine for the acute treatment of severe suicidal ideation: double blind, randomised placebo controlled trial British medical journal February 2, 2022
and 6 more in the library