The Role of HNKs in the Antidepressant Effect of Ketamine

• Status: Terminated
• Trial end date: 2020-07-02
• Target enrollment: 0
• Participant gender: All

Summary

The objective of the proposed study is to examine the relationship between serum concentrations of HNK and changes in the Hamilton Depression Rating Scale (HDRS), Beck Depression Inventory (BDI), and the Profile of Mood States (POMS), as well as glutamatergic/GABAergic response. To achieve these aims the investigators propose a double-blind, uncontrolled (no placebo, no healthy control subjects) study with several different doses of ketamine. The investigators will conduct MRI scans to measure Glu and GABA before and during the ketamine treatment.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Columbia University
• Treatments: Antidepressive Agents; Ketamine

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:

• 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.