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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

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
Depression Drug: Ketamine Early Phase 1

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Study Type : Interventional  (Clinical Trial)
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 : July 2013
Actual Primary Completion Date : June 2021
Actual Study Completion Date : June 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Ketamine

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



Primary Outcome Measures :
  1. Glutamate Metabolism [ Time Frame: 40-75 minutes ]


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02037035


Locations
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United States, Connecticut
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
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Principal Investigator: Lynnette Averill, PhD Yale School of Medicine
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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT02037035    
Other Study ID Numbers: 1305011972
1K23MH101498-01 ( U.S. NIH Grant/Contract )
First Posted: January 15, 2014    Key Record Dates
Last Update Posted: September 8, 2021
Last Verified: September 2021
Additional relevant MeSH terms:
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Depression
Behavioral Symptoms
Ketamine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action