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Ketamine Co-induction for Patients With Major Depressive Disorder

Primary Purpose

Ketamine, Depression, Anesthesia

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Ketamine Hydrochloride
Propofol
Fentanyl
Sponsored by
University of Saskatchewan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ketamine

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosis of major depressive disorder
  • Presentation for gynecologic surgery requiring a general anesthetic

Exclusion Criteria:

  • Marked co-morbid cardiovascular disease
  • Marked co-morbid respiratory disease
  • History of intracranial hypertension
  • History of seizures
  • ASA Physical Status Classification IV or greater
  • History of psychosis
  • Current pregnancy
  • Contraindication to ketamine administration

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Control Arm

    Ketamine Arm

    Arm Description

    As part of the patient's anesthetic induction, they will receive propofol and fentanyl.

    As part of the patient's anesthetic induction, they will receive propofol, fentanyl, as well as ketamine hydrochloride.

    Outcomes

    Primary Outcome Measures

    Depression Severity
    Severity of depression as measured by Montgomery-Asberg Depression Rating Scale (MADRS), 0-60 where 0 to 6 is normal, 7-19 is mild depression, 20-34 is moderate depression, and >34 is severe depression.
    Depression Severity
    Severity of depression as measured by Montgomery-Asberg Depression Rating Scale (MADRS), 0-60 where 0 to 6 is normal, 7-19 is mild depression, 20-34 is moderate depression, and >34 is severe depression.
    Depression Severity
    Severity of depression as measured by Montgomery-Asberg Depression Rating Scale (MADRS), 0-60 where 0 to 6 is normal, 7-19 is mild depression, 20-34 is moderate depression, and >34 is severe depression.
    Depression Severity
    Severity of depression as measured by Montgomery-Asberg Depression Rating Scale (MADRS), 0-60 where 0 to 6 is normal, 7-19 is mild depression, 20-34 is moderate depression, and >34 is severe depression.

    Secondary Outcome Measures

    Pain Score
    Verbally reported numeric pain score (out of 10)
    Pain Score
    Verbally reported numeric pain score (out of 10)
    Pain Score
    Verbally reported numeric pain score (out of 10)
    Pain Score
    Verbally reported numeric pain score (out of 10)
    Pain Score
    Verbally reported numeric pain score (out of 10)
    Analgesia use
    Morphine equivalents (in milligrams)
    Analgesia use
    Morphine equivalents (in milligrams)
    Analgesia use
    Morphine equivalents (in milligrams)
    Analgesia use
    Morphine equivalents (in milligrams)
    Analgesia use
    Morphine equivalents (in milligrams)

    Full Information

    First Posted
    August 15, 2018
    Last Updated
    September 12, 2018
    Sponsor
    University of Saskatchewan
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03666494
    Brief Title
    Ketamine Co-induction for Patients With Major Depressive Disorder
    Official Title
    Ketamine Co-induction for Patients With Major Depressive Disorder; a Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    December 2018 (Anticipated)
    Primary Completion Date
    December 2019 (Anticipated)
    Study Completion Date
    December 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Saskatchewan

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    Yes
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Ketamine hydrochloride, an anesthetic medication, has been demonstrated to acutely and rapidly improve depressive symptoms but not yet been adequately studied for this effect when used as part of a general anesthetic for surgery. This proposed single-centre, double-blinded, randomized clinical trial of adult patients with depression presenting for gynecologic surgery would compare severity of depressive symptoms between patients receiving and not receiving ketamine as part of their general anesthetic.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Ketamine, Depression, Anesthesia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Control Arm
    Arm Type
    Active Comparator
    Arm Description
    As part of the patient's anesthetic induction, they will receive propofol and fentanyl.
    Arm Title
    Ketamine Arm
    Arm Type
    Active Comparator
    Arm Description
    As part of the patient's anesthetic induction, they will receive propofol, fentanyl, as well as ketamine hydrochloride.
    Intervention Type
    Drug
    Intervention Name(s)
    Ketamine Hydrochloride
    Intervention Description
    As part of anesthetic induction, the addition of ketamine hydrochloride 0.5mg/kg.
    Intervention Type
    Drug
    Intervention Name(s)
    Propofol
    Intervention Description
    As part of the patient's anesthetic induction, they will receive propofol.
    Intervention Type
    Drug
    Intervention Name(s)
    Fentanyl
    Intervention Description
    As part of the patient's anesthetic induction, they will receive fentanyl.
    Primary Outcome Measure Information:
    Title
    Depression Severity
    Description
    Severity of depression as measured by Montgomery-Asberg Depression Rating Scale (MADRS), 0-60 where 0 to 6 is normal, 7-19 is mild depression, 20-34 is moderate depression, and >34 is severe depression.
    Time Frame
    At time of discharge from post-anesthetic care unit, until 3 hours post operatvie
    Title
    Depression Severity
    Description
    Severity of depression as measured by Montgomery-Asberg Depression Rating Scale (MADRS), 0-60 where 0 to 6 is normal, 7-19 is mild depression, 20-34 is moderate depression, and >34 is severe depression.
    Time Frame
    72 hours post-operative
    Title
    Depression Severity
    Description
    Severity of depression as measured by Montgomery-Asberg Depression Rating Scale (MADRS), 0-60 where 0 to 6 is normal, 7-19 is mild depression, 20-34 is moderate depression, and >34 is severe depression.
    Time Frame
    7-days post-operative
    Title
    Depression Severity
    Description
    Severity of depression as measured by Montgomery-Asberg Depression Rating Scale (MADRS), 0-60 where 0 to 6 is normal, 7-19 is mild depression, 20-34 is moderate depression, and >34 is severe depression.
    Time Frame
    30-days post-operative
    Secondary Outcome Measure Information:
    Title
    Pain Score
    Description
    Verbally reported numeric pain score (out of 10)
    Time Frame
    Pre-operatively
    Title
    Pain Score
    Description
    Verbally reported numeric pain score (out of 10)
    Time Frame
    Upon discharge from PACU, up to 3 hours postoperative
    Title
    Pain Score
    Description
    Verbally reported numeric pain score (out of 10)
    Time Frame
    72 hours post-opertaive
    Title
    Pain Score
    Description
    Verbally reported numeric pain score (out of 10)
    Time Frame
    7-days post-op
    Title
    Pain Score
    Description
    Verbally reported numeric pain score (out of 10)
    Time Frame
    30-days post-op
    Title
    Analgesia use
    Description
    Morphine equivalents (in milligrams)
    Time Frame
    Pre-operatively
    Title
    Analgesia use
    Description
    Morphine equivalents (in milligrams)
    Time Frame
    Upon discharge from PACU, up to 3 hours postoperative
    Title
    Analgesia use
    Description
    Morphine equivalents (in milligrams)
    Time Frame
    72 hours post-operative
    Title
    Analgesia use
    Description
    Morphine equivalents (in milligrams)
    Time Frame
    7-days post-operative
    Title
    Analgesia use
    Description
    Morphine equivalents (in milligrams)
    Time Frame
    30-days post-operative

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Diagnosis of major depressive disorder Presentation for gynecologic surgery requiring a general anesthetic Exclusion Criteria: Marked co-morbid cardiovascular disease Marked co-morbid respiratory disease History of intracranial hypertension History of seizures ASA Physical Status Classification IV or greater History of psychosis Current pregnancy Contraindication to ketamine administration
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jonathan Gamble, MD
    Phone
    306-655-1183
    Email
    j_gamble@yahoo.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jordon Steeg, MD
    Phone
    306-222-9782
    Email
    jordon.steeg@usask.ca
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jonathan Gamble, MD
    Organizational Affiliation
    University of Saskatchewan
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    12088953
    Citation
    Kudoh A, Takahira Y, Katagai H, Takazawa T. Small-dose ketamine improves the postoperative state of depressed patients. Anesth Analg. 2002 Jul;95(1):114-8, table of contents. doi: 10.1097/00000539-200207000-00020.
    Results Reference
    background
    PubMed Identifier
    25010396
    Citation
    McGirr A, Berlim MT, Bond DJ, Fleck MP, Yatham LN, Lam RW. A systematic review and meta-analysis of randomized, double-blind, placebo-controlled trials of ketamine in the rapid treatment of major depressive episodes. Psychol Med. 2015 Mar;45(4):693-704. doi: 10.1017/S0033291714001603. Epub 2014 Jul 10.
    Results Reference
    background
    PubMed Identifier
    25698228
    Citation
    Lee EE, Della Selva MP, Liu A, Himelhoch S. Ketamine as a novel treatment for major depressive disorder and bipolar depression: a systematic review and quantitative meta-analysis. Gen Hosp Psychiatry. 2015 Mar-Apr;37(2):178-84. doi: 10.1016/j.genhosppsych.2015.01.003. Epub 2015 Jan 15.
    Results Reference
    background
    PubMed Identifier
    25038867
    Citation
    Fond G, Loundou A, Rabu C, Macgregor A, Lancon C, Brittner M, Micoulaud-Franchi JA, Richieri R, Courtet P, Abbar M, Roger M, Leboyer M, Boyer L. Ketamine administration in depressive disorders: a systematic review and meta-analysis. Psychopharmacology (Berl). 2014 Sep;231(18):3663-76. doi: 10.1007/s00213-014-3664-5. Epub 2014 Jul 20.
    Results Reference
    background
    PubMed Identifier
    21557878
    Citation
    Larkin GL, Beautrais AL. A preliminary naturalistic study of low-dose ketamine for depression and suicide ideation in the emergency department. Int J Neuropsychopharmacol. 2011 Sep;14(8):1127-31. doi: 10.1017/S1461145711000629. Epub 2011 May 5.
    Results Reference
    background
    PubMed Identifier
    24688759
    Citation
    Caddy C, Giaroli G, White TP, Shergill SS, Tracy DK. Ketamine as the prototype glutamatergic antidepressant: pharmacodynamic actions, and a systematic review and meta-analysis of efficacy. Ther Adv Psychopharmacol. 2014 Apr;4(2):75-99. doi: 10.1177/2045125313507739.
    Results Reference
    background
    PubMed Identifier
    10686270
    Citation
    Berman RM, Cappiello A, Anand A, Oren DA, Heninger GR, Charney DS, Krystal JH. Antidepressant effects of ketamine in depressed patients. Biol Psychiatry. 2000 Feb 15;47(4):351-4. doi: 10.1016/s0006-3223(99)00230-9.
    Results Reference
    background

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    Ketamine Co-induction for Patients With Major Depressive Disorder

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