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: Recruiting Phase 3 study of Suicide, Attempted, sponsored by Tatiana Falcone, MD.
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. According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
Remission of suicide symptoms will be defined by a 50% or greater reduction in the clinician-rated baseline Beck Scale for Suicidal Ideation (SSI) score, and SSI score less than the score of 4. SSI scores can range from 0 to 38, and a higher score indicates increased severity of suicidal ideation. The primary outcome of the remission rate will be compared between the two groups.
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 |
What NCT04763343 shows while recruiting
NCT04763343 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 378-participant average among 36 other Suicide, Attempted trials with a reported enrollment target (84% lower).
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 a single indexed study location in 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.
Where NCT04763343's enrollment target sits among peer trials
60 30th of 36 higher than 6 of 36 other Suicide, Attempted trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Suicide, Attempted trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00576069 · 60 participants
Mechanism(s)of Airflow Limitation in Moderate-severe Persistent Asthma
- NCT01297400 · 60 participants · Phase 2
Phase 2 Pilot Study of the Safety and Efficacy of Topical MW-III in Thermal Burns
- NCT01734122 · 60 participants
Stereotactic Radiosurgery for Essential Tremor and Parkinsonian Tremor
- NCT01804634 · 60 participants · Phase 2
Reduced Intensity Haploidentical BMT for High Risk Solid Tumors
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI