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History of Changes for Study: NCT02037035
Examining The Effect Of Ketamine On Glutamate/Glutamine Cycling
Latest version (submitted September 7, 2021) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 January 14, 2014 None (earliest Version on record)
2 January 20, 2015 Study Status and Study Design
3 October 6, 2015 Sponsor/Collaborators and Study Status
4 May 11, 2016 Contacts/Locations, Study Status and Eligibility
5 January 5, 2017 Study Status and Contacts/Locations
6 November 6, 2017 Study Status and Contacts/Locations
7 February 7, 2018 Contacts/Locations and Study Status
8 May 1, 2018 Recruitment Status, Study Status, Contacts/Locations and Study Design
9 August 22, 2018 Study Status
10 September 23, 2019 Study Status
11 January 17, 2020 Study Status
12 March 4, 2020 Study Status and Study Identification
13 May 15, 2020 Study Status and Contacts/Locations
14 September 7, 2021 Recruitment Status and Study Status
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Study NCT02037035
Submitted Date:  January 14, 2014 (v1)

Open or close this module Study Identification
Unique Protocol ID: 1305011972
Brief Title: Examining The Effect Of Ketamine On Glutamate/Glutamine Cycling
Official Title: Examining The Effect Of Ketamine On Glutamate/Glutamine Cycling
Secondary IDs:
Open or close this module Study Status
Record Verification: January 2014
Overall Status: Recruiting
Study Start: July 2013
Primary Completion: July 2018 [Anticipated]
Study Completion:
First Submitted: November 19, 2013
First Submitted that
Met QC Criteria:
January 14, 2014
First Posted: January 15, 2014 [Estimate]
Last Update Submitted that
Met QC Criteria:
January 14, 2014
Last Update Posted: January 15, 2014 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Yale University
Responsible Party: Principal Investigator
Investigator: Chadi Abdallah
Official Title: Assistant Professor
Affiliation: Yale University
Collaborators: National Institute of Mental Health (NIMH)
American Psychiatric Association
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: No
Open or close this module Study Description
Brief Summary: This study is looking at the mechanisms underlying the behavioral effects of ketamine in healthy and depressed individuals.
Detailed Description:
Open or close this module Conditions
Conditions: Depression
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Basic Science
Study Phase: Early Phase 1
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Single (Participant)
Allocation: Non-Randomized
Enrollment: 36 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Healthy
Healthy participants will receive ketamine in the scan
Drug: Ketamine
Experimental: Depressed
Depressed participants will receive ketamine in the scan
Drug: Ketamine
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Glutamate Metabolism
[ Time Frame: 40-75 minutes ]

Open or close this module Eligibility
Minimum Age: 21 Years
Maximum Age: 65 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: Yes
Criteria:

Healthy Group

Inclusion Criteria:

  • Male or female between the ages of 21-45 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 250 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.
  • Subjects who test positive for HIV or viral hepatitis (hepatitis B and/or C)
  • Any history indicating learning disability, or mental retardation.
  • Known sensitivity to ketamine.
  • Body circumference of 52 inches or greater.
  • Body weight of 250 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.
Open or close this module Contacts/Locations
Central Contact Person: Chadi Abdallah
Email: chadi.abdallah@yale.edu
Study Officials: Chadi Abdallah, MD
Principal Investigator
Yale School of Medicine
Locations: United States, Connecticut
Yale Depression Research Program
[Recruiting]
New Haven, Connecticut, United States, 06511
Contact:Principal Investigator: Chadi Abdallah, MD
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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