Recruiting
Phase 2
Phase 3

Ketamine

Sponsor:

Nationwide Children's Hospital

Code:

NCT02048423

Conditions

Major Depressive Disorder

Eligibility Criteria

Sex: All

Age: 12 - 17

Healthy Volunteers: Not accepted

Interventions

Ketamine

Study Details

Brief 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.

Conditions

Major Depressive Disorder

Study ID

NCT02048423

Start date

Jun, 2013

Status verified date

Jan, 2014

Completion date

Jun, 2015

Anticipated

Primary completion date

Jun, 2015

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12 - 17

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Ketamine

Drug

Interventions

Ketamine

IV Ketamine, 0.5 mg/kg X 15 mins. in PACU

Primary outcome measure

  • Change in Quick Inventory of Depression Clinician (QIDS-C) total scores from baseline to endpoint and Clinical Global Improvement Score. [ Time Frame: 2 days ]

Central Contacts and Locations

Central contacts

Robert A Kowatch, MD, PhD

614-355-2872robert.kowatch@nationwidechildrens.org

Melinda Helton, Pharm

614-722-2607

Locations

Nationwide Children's Hospital

Recruiting

Columbus, Ohio, United States, 43205

Contacts

Melinda Helton, RN

614-722-2607

More Information

Sponsor

Nationwide Children's Hospital

Last update posted

Jan 29, 2014

Last verified

Jan, 2014

Keywords

  • suicidal

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Nationwide Children's Hospital on 2014-01-29.