Examining The Effect Of Ketamine On Glutamate/Glutamine Cycling

NCT02037035 | Completed Early Phase 1

• 2 other identifiers: 13050119721K23MH101498-01
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

This study is looking at the mechanisms underlying the behavioral effects of ketamine in healthy and depressed individuals.

Conditions

Depression

Outcome Measures

Primary Outcomes (1)

• Glutamate Metabolism

  40-75 minutes

Study Arms (2)

Healthy

EXPERIMENTAL

Healthy participants will receive ketamine in the scan

Drug: Ketamine

Depressed

EXPERIMENTAL

Depressed participants will receive ketamine in the scan

Drug: Ketamine

Interventions

Ketamine DRUG

Depressed; Healthy

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female between the ages of 21-65 years.
• Able to provide written informed consent.
• Able to read and write English.

You may not qualify if:

• Personal or first-degree family member with history of mood, anxiety, or psychotic axis I DSM-IV disorders confirmed after comprehensive psychiatric evaluation.
• Any history of serious medical or neurological illness.
• Any signs of major medical or neurological illness on examination or as a result of ECG screening or laboratory studies.
• Lifetime history of psychoactive substance or alcohol dependence or substance or alcohol abuse (other than nicotine or caffeine abuse), or drinking more that 5 drinks/week during the last year.
• Abnormality on physical examination.
• A positive pre-study (screening) urine drug screen or, at the study physician's discretion on any drug screens given before the scans.
• Pregnant or lactating women or a positive urine pregnancy test for women of child-bearing potential at screening or prior to any imaging day.
• Subjects who test positive for HIV or viral hepatitis (hepatitis B and/or C)
• Has received either prescribed or over-the-counter (OTC) centrally active medicine or herbal supplements within the week prior to the MRI scan.
• Any history indicating learning disability, mental retardation, or attention deficit disorder.
• Known sensitivity to ketamine.
• Body circumference of 52 inches or greater.
• Body weight of 280 pounds or greater.
• History of claustrophobia.
• Presence of cardiac pacemaker or other electronic device or ferromagnetic metal foreign bodies in vulnerable positions as assessed by a standard pre-MRI screening questionnaire.

Sponsors & Collaborators

• Yale University: lead
• National Institute of Mental Health (NIMH): collaborator
• American Psychiatric Association: collaborator

Study Sites (1)

Yale Depression Research Program

New Haven, Connecticut, 06511, United States

Location

MeSH Terms

Conditions

Depression

Interventions

Ketamine

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Lynnette Averill, PhD

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2013
• First Posted: January 15, 2014
• Study Start: July 1, 2013
• Primary Completion: June 1, 2021
• Study Completion: June 1, 2021
• Last Updated: September 8, 2021

Record last verified: 2021-09

Locations

US (1)