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. 2021 Sep 12;2021(9):CD011612. doi: 10.1002/14651858.CD011612.pub3

NCT01935115.

Study name A prospective randomized double‐blinded control trial using ketamine or propofol anesthesia for electroconvulsive therapy: improving treatment‐resistant depression
Methods Allocation: randomised
Endpoint classification: safety/efficacy study
Intervention model: parallel assignment
Masking: double‐blind (participant, caregiver, investigator, outcomes assessor)
Participants Inclusion criteria
  • Fulfill the diagnostic criteria for major depression according to the Diagnostic and Statistical Manual of Mental Disorders (most recent edition)

  • Failure to respond to at least 2 adequate drug therapies for the current depression episode

  • MADRS score of 20 or above (moderate ‐ severe

  • ASA physical status classification I to III


Exclusion criteria
  • Inability to obtain informed consent

  • ASA physical status classification IV

  • Complication by any serious physical diseases such as cardiovascular disease (including untreated HTN), respiratory disease, cerebrovascular disease, intracranial HTN (including glaucoma), or seizures

  • Presence of foreign body (including pacemaker)

  • Pregnancy

  • Allergies to anaesthetics used in study includes: a) ketamine b) propofol c) eggs d) egg products e) soybeans f) soy products

Interventions ketamine 0.75 mg/kg intravenously versus propofol 1 mg/kg
Outcomes Primary outcome measures: The primary outcome is defined as the number of ECT treatments required to reach a 50% reduction in baseline MADRS (Montgomery‐Asberg Depression Scale) score. Time frame: after 8 treatments or completion of therapy for an expected average of 4 weeks
Starting date September 2013
Contact information mailto:J_Gamble%40yahoo.com?subject=NCT01935115, UofSKetamine‐01, Comparing Ketamine and Propofol Anesthesia for Electroconvulsive Therapy
Notes NCT01935115