NCT03977675

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for phase_1 major-depressive-disorder

Timeline
Completed

Started May 2019

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 15, 2019

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

June 5, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 6, 2019

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 2, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 2, 2020

Completed
Last Updated

January 22, 2021

Status Verified

January 1, 2021

Enrollment Period

1.1 years

First QC Date

June 5, 2019

Last Update Submit

January 20, 2021

Conditions

Major Depressive Disorder

Keywords

Magnetic Resonance SpectroscopyKetamine

Outcome Measures

Primary Outcomes (2)

  • Change in HNK Plasma Concentration

    HNK levels will be measured after ketamine administration.

    Baseline and 80 minutes post-infusion

  • Change in DHNK Plasma Concentration

    DHNK levels will be measured after ketamine administration.

    Baseline and 80 minutes post-infusion

Study Arms (3)

Ketamine 0.3 mg/kg

EXPERIMENTAL

Subjects are assigned to receive a dose of 0.3 mg/kg of Ketamine.

Drug: Ketamine

Ketamine 0.5 mg/kg

EXPERIMENTAL

Subjects are assigned to receive a dose of 0.5 mg/kg of Ketamine.

Drug: Ketamine

Ketamine 0.7 mg/kg

EXPERIMENTAL

Subjects are assigned to receive a dose of 0.7 mg/kg of Ketamine.

Drug: Ketamine

Interventions

KetamineDRUG

Patients are assigned to one of three ketamine doses (0.3, 0.5, or 0.7 mg/kg) that will be administered intravenously.

Ketamine 0.3 mg/kgKetamine 0.5 mg/kgKetamine 0.7 mg/kg

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York State Psychiatric Institute

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Ketamine

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

CyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Michael Grunebaum, MD

    New York Psychiatric Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 5, 2019

First Posted

June 6, 2019

Study Start

May 15, 2019

Primary Completion

July 2, 2020

Study Completion

July 2, 2020

Last Updated

January 22, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)