Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04763343 · ClinicalTrials.gov registry record · Phase 3
Ketamine Treatment of Youth Suicide Attempters
A Phase 3 study of Suicide, Attempted, sponsored by Tatiana Falcone, MD.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 60
- Enrollment target
- 2
- Study locations
NCT04763343 is a Phase 3 study of Suicide, Attempted that is actively recruiting participants, run by Tatiana Falcone, MD. The registered enrollment target is 60 participants, below the 378-participant average among 36 other Suicide, Attempted trials with a reported enrollment target (84% lower). The trial reports 2 study locations across 2 states.
The verdict
NCT04763343, a Phase 3 study of Suicide, Attempted, is actively recruiting participants, sponsored by Tatiana Falcone, MD.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 60 participants
- Enrollment target
- 2
- Study locations
Study Summary
Ketamine, an NMDA antagonist, has been shown to have rapid anti- suicidal effects. However, its safety and efficacy and special populations has not been investigated and documented. Several reports in adults suggest rapid decrease of suicidal ideation. In the last decade there is an alarming increase of the number of suicide attempts in patients ages 14-30. Suicide is the second leading cause of death in this population. Patients with previous history of suicide attempt, are even in a higher risk category. The present study focus in this high risk group of suicide attempters. This will be a randomized controlled trial enrolling 60 youth between the ages 14-30 after a suicide attempt; patients will be randomized to receive Ketamine 0.5 mg/kg over 40 minutes or normal saline. Patients will receive all Ketamine or placebo infusions while admitted in the Inpatient Psychiatry Service. Patients will receive up to 6 ketamine or placebo infusions until, for 3 consecutive sessions, they have a clinician rated Scale for Suicidal Ideation (SSI) score of\<4, and \>50% decrease from baseline, and clinical assessment of patient not being suicidal, or they have been discharged from the inpatient unit. Patients will participate in weekly sessions of Collaborative Assessment for the management of Suicidality (CAMS), from the first week of the study while admitted to the hospital and will continue it on a weekly basis post-discharge until the patient has three consecutive outpatient CAMS sessions with an overall risk \< 2 (# 6 on the SSF Core Assessment) along with a positive response regarding their thoughts/feelings and clinician indicating behavioral stability (suicidal behavior).
Conditions Studied
Interventions
- DRUG Saline
- DRUG Ketamine Hydrochloride
- BEHAVIORAL CAMS Therapy
Study Locations (2)
Massachusetts
- Massachusetts General Hospital - Boston
Ohio
- The Cleveland Clinic - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2022-06-27 |
| Est. Completion | 2026-08-31 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04763343
The ClinicalTrials.gov registry entry for NCT04763343 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 378-participant average among 36 other Suicide, Attempted trials with a reported enrollment target (84% lower). The listed sponsor is Tatiana Falcone, MD, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Suicide, Attempted appearing as the primary indexed condition, and to 3 interventions - of which Saline is the first listed.
NCT04763343 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Massachusetts, Ohio.
Frequently Asked Questions
What is clinical trial NCT04763343 about?
NCT04763343 is a clinical study titled "Ketamine Treatment of Youth Suicide Attempters". Ketamine, an NMDA antagonist, has been shown to have rapid anti- suicidal effects. However, its safety and efficacy and special populations has not been investigated and documented. Several reports in adults suggest rapid decrease of suicidal ideation. In the last decade there is an alarming increas...
What is the current status of trial NCT04763343?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 60 participants. The study started on 2022-06-27. Estimated completion is 2026-08-31.
What conditions does trial NCT04763343 study?
This clinical trial studies the following conditions: Suicide, Attempted.
What interventions are being tested in trial NCT04763343?
The interventions under investigation include: Saline (DRUG), Ketamine Hydrochloride (DRUG), CAMS Therapy (BEHAVIORAL).
Who is sponsoring clinical trial NCT04763343?
This trial is sponsored by Tatiana Falcone, MD, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04763343 being conducted?
This trial has 2 study locations across Massachusetts, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Suicide, Attempted
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
Ketamine Versus Midazolam for Recurrence of Suicidality in Adolescents
COMPLETED · Phase 3
-
Community-Based Cognitive Therapy for Suicide Attempters
COMPLETED · Phase 3
-
Virtual Reality Lethal Means Safety Training
RECRUITING · NA
-
Skills to Enhance Positivity in Suicidal Youth
RECRUITING · NA
-
Neural-Derived Plasma Exosomal MicroRNAs As Promising Novel Biomarkers for Suicidality and Treatment Outcome in Adolescents
RECRUITING · NA
-
Suicide Intervention for Alaska Native Youth
RECRUITING · NA
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.