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Unknown statusPhase 2 / Phase 3

An Open Prospective Trial of IV Ketamine in Suicidal Adolescents

NCT02048423 · Nationwide Children's Hospital

Closed to entry
Status
Not accepting participants
Phase 2 / Phase 3
Phase
10
Target enrolment
1
Study sites
1 US states

What it is testing

Summary

1. Investigate the safety and effectiveness of a single dose of IV Ketamine for adolescents with suicidal ideation and depression. It is hypothesize that Ketamine will be well tolerated and significantly reduce depressive symptoms and suicidal ideation. 2. Explore whether decision making as measured by the Iowa Gambling Task changes before and after Ketamine infusion. It is hypothesize that IV Ketamine infusion will significantly improve the decision making ability a measured by the Iowa Gambling Task in adolescents that are suicidal.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Change in Quick Inventory of Depression Clinician (QIDS-C) total scores from baseline to endpoint and Clinical Global Improvement Score.

    Measured over 2 days

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

12 Years to 17 Years
Ages
All
Sex
Not accepted
Healthy volunteers
Inclusion Criteria * Subjects age 12 years 0 months to 17 years, 11 months old * Voluntary admission for a suicide attempt requiring medical intervention in the previous 24-48 hours (Kiddie Schedule for Affective Disorders Suicide Behavior Score \> 3). * Meets criteria for major depression, single- or recurrent episode, non-psychotic or Bipolar I, current episode depressed, with a baseline Inventory for depression score of \> 16. * The patient and legal guardian must understand the nature of the study and be able to comply with protocol requirements. The legal guardian must give written informed consent and the youth, written assent. * English is spoken as the primary language in the home. Exclusion Criteria * Any serious, unstable medical illness or clinically significant abnormal laboratory assessments that would adversely impact the scientific interpretability or unduly increase the risks of the protocol. * Admitted to Nationwide Children's Hospital involuntarily. * Unable to assent because of severe mental retardation or incapacitating psychosis. * Other medications: See Table 1. The list in Table 1 is not exhaustive. The Principal Investigator and the Co-Investigator will review all concomitant medicines and any medicine that could interfere with the trial will be considered exclusionary. Subjects with bipolar disorder will be allowed to continue their mood stabilizers and or antipsychotic agents at the discretion of the investigator. Stimulants use is acceptable, though the child must be on a stable dose for the past 3 months and the dose must not be changed through the trial. A stable dose is defined as no more that 25% change in the total daily dose of a stimulant. * General medical conditions: children with major medical conditions that would interfere with involvement in the study or the study medication will not be enrolled. * Exclusionary Psychiatric Conditions: Autism, substance dependence, psychosis or psychotic major depression. * History of physical, sexual, or emotional abuse, which results in a clinically significant impact on clinical presentation, potentially driving some of the symptoms of major depressive disorder. * Receipt of an investigational drug within 30 days prior to study entry.

Where

1 study site

FacilityCityRegionCountry
Nationwide Children's HospitalColumbusOhioUnited States

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT02048423 on ClinicalTrials.gov →

Last updated in the registry 2014-01-29. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits

Substance

Recruiting in