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Examining The Effect Of Ketamine On Glutamate/Glutamine Cycling

Examining The Effect Of Ketamine On Glutamate/Glutamine Cycling

Status
Completed
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02037035
Enrollment
36
Registered
2014-01-15
Start date
2013-07-31
Completion date
2021-06-30
Last updated
2021-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression

Brief summary

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

Interventions

DRUGKetamine

Sponsors

National Institute of Mental Health (NIMH)
CollaboratorNIH
American Psychiatric Association
CollaboratorOTHER
Yale University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

Healthy Group Inclusion Criteria: * Male or female between the ages of 21-65 years. * Able to provide written informed consent. * Able to read and write English.

Exclusion criteria

* 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. * Donation of blood in excess of 500 mL within 56 days prior to dosing. * History of sensitivity to heparin or heparin-induced thrombocytopenia. * Resting blood pressure lower than 90/60 or higher than 150/90,or resting heart rate lower than 45/min or higher than 100/min. Depression Group Inclusion Criteria: * Male or female between the ages of 21-65 years. * Able to provide written informed consent. * Current MDD Single Episode (296.2x) or Recurrent (296.3x), as determined by the Structured Clinical Interview for DSM-IV (SCID) patient edition * Montgomery Asberg Depression Rating Scale (MADRS) score of 18 or higher at baseline and start of first 13C-MRS. * Quick Inventory of Depressive Symptoms - Self-Report (QIDS-SR16) score of 19 or higher at baseline and start of first 13C-MRS. * No psychotropic medications for 2 or more weeks (4 weeks for Fluoxetine) prior to first 13C-MRS. * Be able to understand and speak English.

Design outcomes

Primary

MeasureTime frame
Glutamate Metabolism40-75 minutes

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026