Ketamine Versus Midazolam for Recurrence of Suicidality in Adolescents

• Status: Not yet recruiting
• Trial end date: 2024-05-31
• Target enrollment: 0
• Participant gender: All

Summary

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 will be treated through a suicide prevention IOP (typically 6-8 weeks), as well as 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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Texas Southwestern Medical Center
• Collaborator: National Institute of Mental Health (NIMH)
• Treatments: Ketamine; Midazolam

Criteria

Inclusion Criteria

Study participants must:

1. Be adolescents (aged 13-18 years);

2. 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 30 days);

3. Receiving standard of care treatment that includes clinically indicated psychosocial and/or psychopharmacological treatment;

4. Have a current primary diagnosis of a depressive disorder based on the MINI-KID (other psychiatric disorders are acceptable, but must not be primary);

5. Be able to complete assessments in English.

6. 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:

• Study participants must not:

1. Have lifetime schizophrenia, psychotic disorder, pervasive developmental disorder, or mental retardation;

2. Have current mania, hypomania, mixed episode, or obsessive-compulsive disorder;

3. Have a primary diagnosis other than a depressive disorder;

4. 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;

5. If female, be pregnant, lactating, or nursing. Women of childbearing potential must have a negative urine pregnancy test prior to all infusions;

6. Have unstable medical conditions or with clinically significant laboratory values or an electrocardiogram (ECG) that would pose significant risk;

7. Be at serious suicidal risk that cannot be managed in the outpatient setting;

8. Have prior treatment for depression with or contraindications to ketamine, esketamine, or, midazolam;

9. Currently being treated with benzodiazepines, non-benzodiazepine sleeping medication (including zolpidem, eszopiclone, zaleplon, suvorexant, and ramelteon), barbiturates, dextromethorphan and opioids will be asked to discontinue for at least 1 week or 5 half-lives whichever is longer. This applies to the screening period. During this 2-week period, these medications will be avoided, and their use permitted to manage any new side effects as long as their use does not increase the risk of study-drug infusion. ADHD stimulant medications will be permitted with last dose at least 24 hours prior to infusion. All concomitant medications will be evaluated by the study physician to determine if the type and dose of concomitant medication requires discontinuation and will be excluded if the concomitant medication could substantially increase the risk of study infusion.