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An Open Prospective Trial of IV Ketamine in Suicidal Adolescents

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ClinicalTrials.gov Identifier: NCT02048423
Recruitment Status : Unknown
Verified January 2014 by Nationwide Children's Hospital.
Recruitment status was:  Recruiting
First Posted : January 29, 2014
Last Update Posted : January 29, 2014
Sponsor:
Information provided by (Responsible Party):
Nationwide Children's Hospital

Tracking Information
First Submitted Date  ICMJE August 2, 2013
First Posted Date  ICMJE January 29, 2014
Last Update Posted Date January 29, 2014
Study Start Date  ICMJE June 2013
Estimated Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 27, 2014)
Change in Quick Inventory of Depression Clinician (QIDS-C) total scores from baseline to endpoint and Clinical Global Improvement Score. [ Time Frame: 2 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: January 27, 2014)
Clinical Global Assessment Scale [ Time Frame: 2 days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE An Open Prospective Trial of IV Ketamine in Suicidal Adolescents
Official Title  ICMJE An Open Prospective Trial of IV Ketamine in Suicidal Adolescents
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.
Detailed Description This is an open prospective study of a single, low dose (0.5 mg/kg) intravenous (IV) Ketamine in 10 adolescent subjects admitted to Nationwide Childrens Hospital following a serious suicide attempt and who meet criteria for major depression or bipolar disorder I, current episode depressed. Subjects will be recruited via the psychiatry consult service, evaluated on the floor and if eligible and consent is obtained, transferred to the PACU for IV Ketamine infusion. Following infusion and when PACU discharge criteria are met, subjects will be transferred back to their floor for medical and psychiatric monitoring until they can be transferred to an inpatient psychiatric unit for additional care. Subjects will be transferred to an inpatient psychiatric unit for continued psychiatric care as part of their routine psychiatric care via the consult team. The research team will follow-up by telephone one week and four weeks after Ketamine injection to collect additional information about the patient's overall course and response.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Major Depressive Disorder
Intervention  ICMJE Drug: Ketamine
IV Ketamine, 0.5 mg/kg X 15 mins. in PACU
Other Names:
  • Ketaset
  • Ketalean
  • Rogarsetic
Study Arms  ICMJE Experimental: Ketamine
Drug
Intervention: Drug: Ketamine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: January 27, 2014)
10
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2015
Estimated Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02048423
Other Study ID Numbers  ICMJE IRB12-00445
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Nationwide Children's Hospital
Study Sponsor  ICMJE Nationwide Children's Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Robert A Kowatch, MD, PhD OSU Medical Center/Nationwide Childrens Hospital
PRS Account Nationwide Children's Hospital
Verification Date January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP