Ignite Creation Date:
2025-12-24 @ 10:34 PM
Ignite Modification Date:
2026-03-14 @ 11:35 AM
Study NCT ID:
NCT02037035
Status:
COMPLETED
Last Update Posted:
2021-09-08
First Post:
2013-11-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Examining The Effect Of Ketamine On Glutamate/Glutamine Cycling
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007649', 'term': 'Ketamine'}], 'ancestors': [{'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2021-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-07', 'studyFirstSubmitDate': '2013-11-19', 'studyFirstSubmitQcDate': '2014-01-14', 'lastUpdatePostDateStruct': {'date': '2021-09-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-01-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Glutamate Metabolism', 'timeFrame': '40-75 minutes'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Depression']}, 'descriptionModule': {'briefSummary': 'This study is looking at the mechanisms underlying the behavioral effects of ketamine in healthy and depressed individuals.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Healthy Group\n\nInclusion Criteria:\n\n* Male or female between the ages of 21-65 years.\n* Able to provide written informed consent.\n* Able to read and write English.\n\nExclusion Criteria:\n\n* Personal or first-degree family member with history of mood, anxiety, or psychotic axis I DSM-IV disorders confirmed after comprehensive psychiatric evaluation.\n* Any history of serious medical or neurological illness.\n* Any signs of major medical or neurological illness on examination or as a result of ECG screening or laboratory studies.\n* 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.\n* Abnormality on physical examination.\n* A positive pre-study (screening) urine drug screen or, at the study physician's discretion on any drug screens given before the scans.\n* Pregnant or lactating women or a positive urine pregnancy test for women of child-bearing potential at screening or prior to any imaging day.\n* Subjects who test positive for HIV or viral hepatitis (hepatitis B and/or C)\n* Has received either prescribed or over-the-counter (OTC) centrally active medicine or herbal supplements within the week prior to the MRI scan.\n* Any history indicating learning disability, mental retardation, or attention deficit disorder.\n* Known sensitivity to ketamine.\n* Body circumference of 52 inches or greater.\n* Body weight of 280 pounds or greater.\n* History of claustrophobia.\n* 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.\n* Donation of blood in excess of 500 mL within 56 days prior to dosing.\n* History of sensitivity to heparin or heparin-induced thrombocytopenia.\n* 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.\n\nDepression Group\n\nInclusion Criteria:\n\n* Male or female between the ages of 21-65 years.\n* Able to provide written informed consent.\n* Current MDD Single Episode (296.2x) or Recurrent (296.3x), as determined by the Structured Clinical Interview for DSM-IV (SCID) patient edition\n* Montgomery Asberg Depression Rating Scale (MADRS) score of 18 or higher at baseline and start of first 13C-MRS.\n* Quick Inventory of Depressive Symptoms - Self-Report (QIDS-SR16) score of 19 or higher at baseline and start of first 13C-MRS.\n* No psychotropic medications for 2 or more weeks (4 weeks for Fluoxetine) prior to first 13C-MRS.\n* Be able to understand and speak English.\n\nExclusion Criteria:\n\n* 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.\n* First-degree family member with history of schizophrenia or any other psychotic disorder.\n* 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.\n* Substance abuse or dependence during the 12 months prior to screening.\n* Any history of serious medical or neurological illness.\n* Any signs of major medical or neurological illness.\n* 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.\n* A positive pre-study (screening) urine drug screen or on any drug screens given before the scans.\n* Pregnant or lactating women or a positive urine pregnancy test for women of childbearing potential at screening or prior to any imaging day.\n* Any history indicating learning disability, or mental retardation.\n* Known sensitivity to ketamine.\n* Body weight of 280 pounds or greater.\n* History of claustrophobia.\n* 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.\n* Donation of blood in excess of 500 mL within 56 days prior to dosing.\n* History of sensitivity to heparin or heparin-induced thrombocytopenia.\n* 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."}, 'identificationModule': {'nctId': 'NCT02037035', 'briefTitle': 'Examining The Effect Of Ketamine On Glutamate/Glutamine Cycling', 'organization': {'class': 'OTHER', 'fullName': 'Yale University'}, 'officialTitle': 'Examining The Effect Of Ketamine On Glutamate/Glutamine Cycling', 'orgStudyIdInfo': {'id': '1305011972'}, 'secondaryIdInfos': [{'id': '1K23MH101498-01', 'link': 'https://reporter.nih.gov/quickSearch/1K23MH101498-01', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Healthy', 'description': 'Healthy participants will receive ketamine in the scan', 'interventionNames': ['Drug: Ketamine']}, {'type': 'EXPERIMENTAL', 'label': 'Depressed', 'description': 'Depressed participants will receive ketamine in the scan', 'interventionNames': ['Drug: Ketamine']}], 'interventions': [{'name': 'Ketamine', 'type': 'DRUG', 'armGroupLabels': ['Depressed', 'Healthy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06511', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale Depression Research Program', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}], 'overallOfficials': [{'name': 'Lynnette Averill, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Yale University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yale University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}, {'name': 'American Psychiatric Association', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}