Examining The Effect Of Ketamine On Glutamate/Glutamine Cycling
Examining The Effect Of Ketamine On Glutamate/Glutamine Cycling
This study is looking at the mechanisms underlying the behavioral effects of ketamine in
 healthy and depressed individuals.
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.