Clinical TrialMajor Depressive Disorder (MDD)KetamineKetamineKetamineTerminated

The Role of HNKs in the Antidepressant Effect of Ketamine

Randomised, parallel Phase I study (n=8) testing three IV ketamine doses (0.3, 0.5, 0.7 mg/kg) to examine relationships between hydroxynorketamine (HNK) serum levels, depressive symptoms, and glutamate/GABA changes.

Target Enrollment
8 participants
Study Type
Phase I interventional
Design
Randomized, double Blind

Detailed Description

Double-blind, randomised, parallel study in participants with current major depressive episodes comparing three single IV ketamine doses (0.3, 0.5, 0.7 mg/kg) to evaluate serum hydroxynorketamine (HNK) in relation to clinical change on HDRS, BDI and POMS.

MRI measures of glutamate and GABA are acquired before and during ketamine treatment to test whether acute neurotransmitter changes mediate antidepressant effects; primary purpose listed as basic science.

Study Protocol

Preparation

sessions

Dosing

1 sessions

Integration

sessions

Study Arms & Interventions

Ketamine 0.3 mg/kg

experimental

Subjects assigned to receive an IV dose of ketamine 0.3 mg/kg.

Interventions

  • Ketamine0.3 mg/kg
    via IV• single dose• 1 doses total

    IV infusion

Ketamine 0.5 mg/kg

experimental

Subjects assigned to receive an IV dose of ketamine 0.5 mg/kg.

Interventions

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

    IV infusion

Ketamine 0.7 mg/kg

experimental

Subjects assigned to receive an IV dose of ketamine 0.7 mg/kg.

Interventions

  • Ketamine0.7 mg/kg
    via IV• single dose• 1 doses total

    IV infusion

Participants

Ages
18 – 65
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • Current major depressive episode (MDE) as part of major depressive disorder (MDD). May be psychiatric medication-free or, if on psychiatric medications, not responding adequately.
  • Off all psychotropic and other types of drugs likely to interact with glutamate for at least 14 days before starting the study OR likely able to tolerate a medication washout.
  • Female subjects of child-bearing potential must be using an acceptable method of birth control throughout the study.

Exclusion Criteria

  • Exclusion Criteria:
  • Lifetime history of schizophrenia, schizoaffective illness, bipolar disorder, or psychosis.
  • First-degree relative with schizophrenia, schizoaffective disorder, or bipolar disorder if the subject is less than 33 years old.
  • Significant uncontrolled physical illness.
  • Electroconvulsive therapy (ECT) within the last 3 months for current MDE.
  • Pregnancy or plans to conceive during the course of study participation.
  • Heart pacemaker, body implant or other metal in body.
  • Neurological disease or prior head trauma with evidence of cognitive impairment.
  • Claustrophobia sufficient to preclude MRI.
  • Prior ineffective trial of, or adverse effect to, ketamine.
  • IV drug use or history of ketamine use as a recreational drug ≥ 2 times or an adverse reaction to ketamine; any other drug or alcohol dependence within past 6 months.

Study Details

Locations

New York State Psychiatric Institute — New York, New York, United States

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