Clinical trial NCT03666494: 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
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Ketamine
Depression
Anesthesia
Lead sponsor: University of Saskatchewan
Sponsor class: OTHER
First posted: 2018-09-11
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Depression Severity
timeFrame: At time of discharge from post-anesthetic care unit, until 3 hours post operatvie
measure: Depression Severity
timeFrame: 72 hours post-operative
measure: Depression Severity
timeFrame: 7-days post-operative
measure: Depression Severity
timeFrame: 30-days post-operative
Secondary outcomes:
measure: Pain Score
timeFrame: Pre-operatively
measure: Pain Score
timeFrame: Upon discharge from PACU, up to 3 hours postoperative
measure: Pain Score
timeFrame: 72 hours post-opertaive
measure: Pain Score
timeFrame: 7-days post-op
measure: Pain Score
timeFrame: 30-days post-op
measure: Analgesia use
timeFrame: Pre-operatively
measure: Analgesia use
timeFrame: Upon discharge from PACU, up to 3 hours postoperative
measure: Analgesia use
timeFrame: 72 hours post-operative
measure: Analgesia use
timeFrame: 7-days post-operative
measure: Analgesia use
timeFrame: 30-days post-operative
Other outcomes:
Locations:
Study officials:
affiliation: University of Saskatchewan
name: Jonathan Gamble, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.
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.