Ketamine Versus Midazolam for Recurrence of Suicidality in Adolescents
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Suicide and Depression
- Suicide Threat
- Suicide, Attempted
- Type
- Interventional
- Phase
- Phase 3
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Youth will be randomized in 1:1 fashion to either intravenous ketamine (0.5 mg/kg) or midazolam (0.02 mg/kg) twice weekly for 2 weeks followed by weekly visits for 10 weeks (for a total of 12-week post-randomization observation period).Masking: Triple (Participant, Care Provider, Investigator)Masking Description: The investigator, patient, and study staff will be blinded. Packaging and labeling of the study drugs will be performed by the research pharmacy in a way to ensure blinding throughout the study. No members of the study team will have access to the randomization scheme during the conduct of the study. The Research Pharmacist and the CDRC (Center for Depression Research and Clinical Care) Program Manager will have access to the treatment assignment in the event of an emergency. The treatment code must not be broken except in medical emergencies when the appropriate management of the patient necessitates knowledge of the treatment randomization. The investigator retains the right to break the code for serious adverse events (SAEs) that are unexpected and are suspected to be causally related to a study drug and that potentially require expedited reporting to regulatory authorities.Primary Purpose: Treatment
Participation Requirements
- Age
- Between 12 years and 18 years
- Gender
- Both males and females
Description
Youth patients (ages 12-18) who have recent suicidality (defined as suicidal ideation or behavior), and who are enrolled or expected to be enrolled in an intensive outpatient program (IOP) will be recruited for participation in the study. Upon informed consent/assent, baseline data will be collected...
Youth patients (ages 12-18) who have recent suicidality (defined as suicidal ideation or behavior), and who are enrolled or expected to be enrolled in an intensive outpatient program (IOP) will be recruited for participation in the study. Upon informed consent/assent, baseline data will be collected regarding mood symptoms, suicidal ideation and behavior, associated comorbidities, and treatment history. Youth participants will be randomized to 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 monitor outcomes. Participants may be recruited directly from the IOP or from the ED or inpatient psychiatric unit, provided they have undergone evaluation and are confirmed to begin IOP treatment. The baseline visit and first infusion must be +/- 10 days of IOP enrollment. Enrollment of 264 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 (screening plus 12 weeks of study follow-up visits). Visits include a Screening Visit, a Baseline, 4 Study Intervention Visits, and 10 Follow-Up 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 frequency of suicidal events associated with two-week twice-weekly course of ketamine treatment versus midazolam. Aim 2. Evaluate reduction in implicit suicidal cognition with ketamine. Aim 3. Evaluate reduction in depressive symptoms and suicidality with ketamine.
Tracking Information
- NCT #
- NCT04592809
- Collaborators
- National Institute of Mental Health (NIMH)
- Investigators
- Principal Investigator: Madhukar Trivedi, MD University of Texas Southwestern Medical Center
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