Examining The Effect Of Ketamine On Glutamate/Glutamine Cycling

Sponsor
Yale University (Other)
Overall Status
Completed
CT.gov ID
NCT02037035
Collaborator
National Institute of Mental Health (NIMH) (NIH), American Psychiatric Association (Other)
36
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Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Early Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
36 participants
Allocation:
Non-Randomized
Intervention Model:
Crossover Assignment
Masking:
Single (Participant)
Primary Purpose:
Basic Science
Official Title:
Examining The Effect Of Ketamine On Glutamate/Glutamine Cycling
Study Start Date :
Jul 1, 2013
Actual Primary Completion Date :
Jun 1, 2021
Actual Study Completion Date :
Jun 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Healthy

Healthy participants will receive ketamine in the scan

Drug: Ketamine

Experimental: Depressed

Depressed participants will receive ketamine in the scan

Drug: Ketamine

Outcome Measures

Primary Outcome Measures

  1. Glutamate Metabolism [40-75 minutes]

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes

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.

Exclusion Criteria:
  • Patients with a history of DSM-IV-TR diagnosis of bipolar disorder or schizophrenia or schizoaffective disorder or currently exhibiting psychotic features associated with their depression; dementia or suspicion thereof, is also exclusionary.

  • First-degree family member with history of schizophrenia or any other psychotic disorder.

  • Serious suicide or homicide risk, as assessed by evaluating clinician; A serious suicide risk will be considered an inability to control suicide attempts, imminent risk of suicide in the investigator's judgment, or a history of serious suicidal behavior, which is defined using the Columbia-Suicide Severity Rating Scale (C-SSRS) as either (1) one or more actual suicide attempts in the 3 years before study entry with the lethality rated at 3 or higher, or (2) one or more interrupted suicide attempts with a potential lethality judged to result in serious injury or death.

  • Substance abuse or dependence during the 12 months prior to screening.

  • Any history of serious medical or neurological illness.

  • Any signs of major medical or neurological illness.

  • Abnormality on physical examination. A subject with a clinical abnormality may be included only if the study physician considers the abnormality will not introduce additional risk factors and will not interfere with the study procedure.

  • A positive pre-study (screening) urine drug screen or on any drug screens given before the scans.

  • Pregnant or lactating women or a positive urine pregnancy test for women of childbearing potential at screening or prior to any imaging day.

  • Any history indicating learning disability, or mental retardation.

  • Known sensitivity to ketamine.

  • 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Yale Depression Research Program New Haven Connecticut United States 06511

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: Lynnette Averill, PhD, Yale School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Yale University
ClinicalTrials.gov Identifier:
NCT02037035
Other Study ID Numbers:
  • 1305011972
  • 1K23MH101498-01
First Posted:
Jan 15, 2014
Last Update Posted:
Sep 8, 2021
Last Verified:
Sep 1, 2021
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 8, 2021