Examining The Effect Of Ketamine On Glutamate/Glutamine Cycling

Completed · Early Phase 1

Conditions studied: Depression

In brief

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

Key facts

Study ID

NCT02037035

Run by

Yale University

People needed

36

Starts

2013-07-01

Expected to finish

2021-06-01

Last updated by the study team

2021-09-08

Who can join

Age: 21 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Male or female between the ages of 21-65 years.
• Able to provide written informed consent.
• Able to read and write English.

You may not qualify if…

• 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.

Where it is running

• Yale Depression Research Program — New Haven, Connecticut, United States

Full record on ClinicalTrials.gov

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