Ketamine Co-induction for Patients With Major Depressive Disorder

Depression Clinical Trial

Official title:

Ketamine Co-induction for Patients With Major Depressive Disorder; a Randomized Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03666494
• Other study ID #: Bio 18-19
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: December 2018
• Est. completion date: December 2019

Study information

• Verified date: August 2018
• Source: University of Saskatchewan
• Contact: Jonathan Gamble, MD
• Phone: 306-655-1183
• Email: j_gamble[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia
• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Ketamine

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Saskatchewan

References & Publications (7)

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. — View 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. Review. — View Citation

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. — View 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. — View 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. Retraction in: Int J Neuropsychopharmacol. 2017 Jul 1;20(7):611. — View 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. Review. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	At time of discharge from post-anesthetic care unit, until 3 hours post operatvie
Primary	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.	72 hours post-operative
Primary	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.	7-days post-operative
Primary	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.	30-days post-operative
Secondary	Pain Score	Verbally reported numeric pain score (out of 10)	Pre-operatively
Secondary	Pain Score	Verbally reported numeric pain score (out of 10)	Upon discharge from PACU, up to 3 hours postoperative
Secondary	Pain Score	Verbally reported numeric pain score (out of 10)	72 hours post-opertaive
Secondary	Pain Score	Verbally reported numeric pain score (out of 10)	7-days post-op
Secondary	Pain Score	Verbally reported numeric pain score (out of 10)	30-days post-op
Secondary	Analgesia use	Morphine equivalents (in milligrams)	Pre-operatively
Secondary	Analgesia use	Morphine equivalents (in milligrams)	Upon discharge from PACU, up to 3 hours postoperative
Secondary	Analgesia use	Morphine equivalents (in milligrams)	72 hours post-operative
Secondary	Analgesia use	Morphine equivalents (in milligrams)	7-days post-operative
Secondary	Analgesia use	Morphine equivalents (in milligrams)	30-days post-operative