- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02037035
Examining The Effect Of Ketamine On Glutamate/Glutamine Cycling
September 7, 2021 updated by: Yale University
This study is looking at the mechanisms underlying the behavioral effects of ketamine in healthy and depressed individuals.
Study Overview
Study Type
Interventional
Enrollment (Actual)
36
Phase
- Early Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Connecticut
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New Haven, Connecticut, United States, 06511
- Yale Depression Research Program
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years to 63 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Healthy
Healthy participants will receive ketamine in the scan
|
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Experimental: Depressed
Depressed participants will receive ketamine in the scan
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Glutamate Metabolism
Time Frame: 40-75 minutes
|
40-75 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Lynnette Averill, PhD, Yale School of Medicine
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2013
Primary Completion (Actual)
June 1, 2021
Study Completion (Actual)
June 1, 2021
Study Registration Dates
First Submitted
November 19, 2013
First Submitted That Met QC Criteria
January 14, 2014
First Posted (Estimate)
January 15, 2014
Study Record Updates
Last Update Posted (Actual)
September 8, 2021
Last Update Submitted That Met QC Criteria
September 7, 2021
Last Verified
September 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Depression
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics, Dissociative
- Anesthetics, Intravenous
- Anesthetics, General
- Anesthetics
- Excitatory Amino Acid Antagonists
- Excitatory Amino Acid Agents
- Ketamine
Other Study ID Numbers
- 1305011972
- 1K23MH101498-01 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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