This double-blind, randomized clinical trial (n=45) evaluated whether ketamine, given as part of an anaesthetic, improves depression symptoms in depressed patients undergoing non-cardiac surgery. Half of the participants received a ketamine infusion during surgery, while the other half received a placebo (normal saline).
Topic Depression
Country United States of America
Visit trial
Status
Completed
Results Published
Yes
Start date
22 August 2019
End date
01 January 2022
Chance of happening
100%
Phase
Phase IV
Design
Blinded
Type
Interventional
Generation
First
Participants
45
Sex
All
Age
18- 80
Therapy
No
Trial Details
Major Depressive Disorder (MDD) is widely prevalent among patients preparing to have surgery, and is a known risk factor for complications after surgery, including wound infection, myocardial infarction and opioid use disorder. Ketamine has emerged as an effective, rapid-acting antidepressant therapy for patients with MDD, and may be a useful tool to prevent MDD-related morbidity in the perioperative period. Ketamine has been well studied for MDD in outpatient clinics where it is given as an infusion (0.5 mg/kg over 40 minutes) in awake patients. Ketamine is often used as part of an anesthetic cocktail in sedated or anesthetized patients, but it is unknown whether ketamine has an antidepressant effect in this context. The investigators will determine whether a ketamine infusion, compared to placebo (normal saline infusion), has an antidepressant effect when given during surgical anesthesia. If ketamine is an effective antidepressant in this population under anesthesia, its use could be incorporated into a set of interventions to minimize the perioperative complications associated with MDD.NCT Number NCT03861988
Sponsors & Collaborators
Stanford UniversityResearchers at Stanford are exploring the potential of ketamine, MDMA and psilocybin by connecting neuroscience, psychiatry and anesthesiology.
Papers
Randomized trial of ketamine masked by surgical anesthesia in patients with depressionThis triple-masked, randomized, placebo-controlled trial (n=40) of adults with major depressive disorder (MDD) found no short-term effect on depression severity (measured by MADRS) after a single dose of intravenous ketamine (35mg/70kg) compared to placebo (saline) during anaesthesia for routine surgery.
Measures Used
Hospital Anxiety and Depression ScaleThe Hospital Anxiety and Depression Scale (HADS) is a frequently used self-rating scale developed to assess psychological distress in non-psychiatric patients.
Montgomery-Asberg Depression Rating Scale
A ten-item diagnostic questionnaire used to measure the severity of depressive symptoms in patients with mood disorders.