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Examining The Effect Of Ketamine On Glutamate/Glutamine Cycling

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02037035
Recruitment Status : Completed
First Posted : January 15, 2014
Last Update Posted : September 8, 2021
Sponsor:
Collaborators:
National Institute of Mental Health (NIMH)
American Psychiatric Association
Information provided by (Responsible Party):
Yale University

Tracking Information
First Submitted Date  ICMJE November 19, 2013
First Posted Date  ICMJE January 15, 2014
Last Update Posted Date September 8, 2021
Study Start Date  ICMJE July 2013
Actual Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 14, 2014)
Glutamate Metabolism [ Time Frame: 40-75 minutes ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Examining The Effect Of Ketamine On Glutamate/Glutamine Cycling
Official Title  ICMJE Examining The Effect Of Ketamine On Glutamate/Glutamine Cycling
Brief Summary This study is looking at the mechanisms underlying the behavioral effects of ketamine in healthy and depressed individuals.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Condition  ICMJE Depression
Intervention  ICMJE Drug: Ketamine
Study Arms  ICMJE
  • Experimental: Healthy
    Healthy participants will receive ketamine in the scan
    Intervention: Drug: Ketamine
  • Experimental: Depressed
    Depressed participants will receive ketamine in the scan
    Intervention: Drug: Ketamine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 14, 2014)
36
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2021
Actual Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02037035
Other Study ID Numbers  ICMJE 1305011972
1K23MH101498-01 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Yale University
Study Sponsor  ICMJE Yale University
Collaborators  ICMJE
  • National Institute of Mental Health (NIMH)
  • American Psychiatric Association
Investigators  ICMJE
Principal Investigator: Lynnette Averill, PhD Yale School of Medicine
PRS Account Yale University
Verification Date September 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP