Clinical TrialMajor Depressive Disorder (MDD)KetamineUnknown status

An Open Prospective Trial of IV Ketamine in Suicidal Adolescents

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.

Target Enrollment
10 participants
Study Type
Phase II/III interventional
Design
Non-randomized

Detailed Description

Open, single-group treatment study (n=10) testing safety and effectiveness of a single IV ketamine infusion (0.5 mg/kg over 15 minutes) for adolescents admitted after a suicide attempt; primary outcomes include depressive symptoms and suicidal ideation.

Secondary assessments include decision-making measured by the Iowa Gambling Task. Participants are treated in PACU for infusion and followed by telephone at one and four weeks to assess course and response.

Study Protocol

Preparation

sessions

Dosing

1 sessions
15 min each

Integration

sessions

Study Arms & Interventions

Ketamine

experimental

Single IV ketamine infusion (0.5 mg/kg) administered in PACU to suicidal adolescents.

Interventions

  • Ketamine0.5 mg/kg
    via IV• single dose• 1 doses total

    Infusion over 15 minutes in PACU

Participants

Ages
12 – 17
Sexes
Male & Female

Inclusion Criteria

  • 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

  • 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 Details

  • Status
    Unknown status
  • Phase
    Phase IIPhase III
  • Type
    interventional
  • Design
    Non-randomized
  • Target Enrollment10 participants
  • Timeline
    Start: 2013-06-01
    End: 2015-06-01
  • Compound
    Ketamine
  • Topic
    Major Depressive Disorder (MDD)

Locations

Nationwide Children's Hospital — Columbus, Ohio, United States

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