Ketamine Co-induction for Patients With Major Depressive Disorder

• ClinicalTrials.gov Identifier: NCT03666494
• Recruitment Status: Unknown
• First Posted: September 11, 2018
• Last Update Posted: September 13, 2018
• Sponsor: University of Saskatchewan
• Information provided by (Responsible Party): University of Saskatchewan

Tracking Information

• First Submitted Date: August 15, 2018
• First Posted Date: September 11, 2018
• Last Update Posted Date: September 13, 2018
• Estimated Study Start Date: December 2018
• Estimated Primary Completion Date: December 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 7, 2018)

• Depression Severity [ Time Frame: At time of discharge from post-anesthetic care unit, until 3 hours post operatvie ]
  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 [ Time Frame: 72 hours post-operative ]
  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 [ Time Frame: 7-days post-operative ]
  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 [ Time Frame: 30-days post-operative ]
  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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: September 7, 2018)

• Pain Score [ Time Frame: Pre-operatively ]
  Verbally reported numeric pain score (out of 10)
• Pain Score [ Time Frame: Upon discharge from PACU, up to 3 hours postoperative ]
  Verbally reported numeric pain score (out of 10)
• Pain Score [ Time Frame: 72 hours post-opertaive ]
  Verbally reported numeric pain score (out of 10)
• Pain Score [ Time Frame: 7-days post-op ]
  Verbally reported numeric pain score (out of 10)
• Pain Score [ Time Frame: 30-days post-op ]
  Verbally reported numeric pain score (out of 10)
• Analgesia use [ Time Frame: Pre-operatively ]
  Morphine equivalents (in milligrams)
• Analgesia use [ Time Frame: Upon discharge from PACU, up to 3 hours postoperative ]
  Morphine equivalents (in milligrams)
• Analgesia use [ Time Frame: 72 hours post-operative ]
  Morphine equivalents (in milligrams)
• Analgesia use [ Time Frame: 7-days post-operative ]
  Morphine equivalents (in milligrams)
• Analgesia use [ Time Frame: 30-days post-operative ]
  Morphine equivalents (in milligrams)

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Treatment

Condition

• Ketamine
• Depression
• Anesthesia

Intervention

• Drug: Ketamine Hydrochloride
  As part of anesthetic induction, the addition of ketamine hydrochloride 0.5mg/kg.
• Drug: Propofol
  As part of the patient's anesthetic induction, they will receive propofol.
• Drug: Fentanyl
  As part of the patient's anesthetic induction, they will receive fentanyl.

Study Arms

• Active Comparator: Control Arm
  As part of the patient's anesthetic induction, they will receive propofol and fentanyl.
  Interventions:

  • Drug: Propofol
  • Drug: Fentanyl
• Active Comparator: Ketamine Arm
  As part of the patient's anesthetic induction, they will receive propofol, fentanyl, as well as ketamine hydrochloride.
  Interventions:

  • Drug: Ketamine Hydrochloride
  • Drug: Propofol
  • Drug: Fentanyl

Publications *

• 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.
• 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. Review.
• 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. Review.
• Fond G, Loundou A, Rabu C, Macgregor A, Lançon 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. Review.
• 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. Retraction in: Int J Neuropsychopharmacol. 2017 Jul 1;20(7):611.
  Retraction in:Int J Neuropsychopharmacol. 2017 Jul 1;20(7):611
• 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. Review.
• 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.

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: September 7, 2018): 50
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 2019
• Estimated Primary Completion Date: December 2019 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT03666494
• Other Study ID Numbers: Bio 18-19
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• 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

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Current Responsible Party: University of Saskatchewan
• Original Responsible Party: Same as current
• Current Study Sponsor: University of Saskatchewan
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Jonathan Gamble, MD; University of Saskatchewan

• PRS Account: University of Saskatchewan
• Verification Date: August 2018