Ketamine Versus Midazolam for Recurrence of Suicidality in Adolescents (NCT04592809) | Clinical Trial Compass
CompletedPhase 3
Ketamine Versus Midazolam for Recurrence of Suicidality in Adolescents
United States50 participantsStarted 2022-10-03
Plain-language 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.
Who can participate
Age range13 Years – 18 Years
SexALL
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Inclusion criteria
✓. Be adolescents (aged 13-18 years);
✓. Have had a recent suicidal event (suicide attempt or significant suicidal ideation with a plan or intent warranting emergency evaluation or inpatient hospitalization within the past 90 days);
✓. Receiving standard of care treatment that includes clinically indicated psychosocial and/or psychopharmacological treatment;
✓. Have a current primary diagnosis of a depressive disorder based on the MINI-KID (other psychiatric disorders are acceptable, but must not be primary);
✓. Participants must be able to complete assessments in English. However, the parent(s) or legal guardians of minors may either speak English or Spanish
✓. Use effective method of contraception during and for 90 days following the end of treatment for female and male participants. Recommended methods of birth control are namely, consistent use of an approved hormonal birth control (pill/patches, rings), an intrauterine device (IUD), contraceptive injection, double barrier methods, sexual abstinence, or sterilization;
Exclusion criteria
✕. Have a psychotic disorder, such as lifetime schizophrenia, or a pervasive or intellectual developmental disorder requiring substantial or very substantial support;
What they're measuring
1
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.
Timeframe: 12 weeks
Trial details
NCT IDNCT04592809
SponsorUniversity of Texas Southwestern Medical Center
✕. Have current mania, hypomania, mixed episode, or obsessive-compulsive disorder;
✕. Have a primary diagnosis other than a depressive disorder;
✕. Have moderate to severe alcohol or substance use disorder within the past six months (based on MINI-KID); If there is a positive urine drug screen at screening, the urine drug screen will be repeated at each infusion visit. Positive urine drug screen will be reviewed by study physician and infusion will proceed as long as no safety risk was identified;
✕. If female, be pregnant, lactating, or nursing; Women of childbearing potential must have a negative urine pregnancy test prior to all infusions;
✕. Have unstable medical conditions (stable for less than 3 months) or with clinically significant laboratory values or an electrocardiogram (ECG) that would pose significant risk;
✕. Be at serious suicidal risk that cannot be managed in the outpatient setting;
✕. Have prior treatment for depression with or contraindications to ketamine, esketamine, or, midazolam;