Ketamine as an Anaesthetic Agent in Electroconvulsive Therapy (ECT)

NCT00680433 | Completed Phase 4

• 1 other identifier: HREC 07281
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 1

Brief Summary

Research into the mechanisms underlying memory impairment in ECT suggests that its development may be prevented by the administration of certain medications at the time of ECT treatment. For example there are reasons to believe that ketamine, also used as an anaesthetic agent, may have such protective properties. In this clinical study patients undergoing a course of ECT will be offered the opportunity to receive a small dose of ketamine (or a placebo) as part of their anaesthetic at the time of ECT treatment. Mood changes and any memory changes will be evaluated to see if the subjects who received ketamine had less memory side effects than those who did not, while still improving their depression.

Conditions

Major Depressive Episode

Outcome Measures

Primary Outcomes (1)

• Memory tests

  Before ECT, after 6 ECT treatments, at the end of the ECT course

Secondary Outcomes (1)

• Depression rating scale

  Before ECT, after each week of treatment, at the end of the ECT course

Study Arms (2)

Active

EXPERIMENTAL

Ketamine

Drug: Ketamine

Placebo

PLACEBO COMPARATOR

Saline (placebo)

Drug: Saline

Interventions

Ketamine DRUG

Ketamine IV will be administered after the administration of the normal anaesthetic agents for ECT.

Active

Saline DRUG

Saline (placebo) will be administered after the normal anaesthetic agents in ECT.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Satisfy DSM-IV-TR criteria for Major Depressive Episode
• years or over
• Does not have a diagnosis of schizophrenia, schizoaffective disorder, rapid cycling bipolar disorder, or current psychotic symptoms
• No known sensitivity to ketamine
• No ECT in the last 3 months
• No drug or alcohol abuse in the last 12 months
• Able to give informed consent
• Score at least 24 on Mini Mental State Examination

Sponsors & Collaborators

• Northside Clinic, Australia: lead
• Wesley Mission: collaborator

Study Sites (1)

Wesley Hospital

Sydney, New South Wales, 2217, Australia

Location

Related Publications (9)

• McDaniel WW, Sahota AK, Vyas BV, Laguerta N, Hategan L, Oswald J. Ketamine appears associated with better word recall than etomidate after a course of 6 electroconvulsive therapies. J ECT. 2006 Jun;22(2):103-6. doi: 10.1097/00124509-200606000-00005.

  PMID: 16801824 BACKGROUND

• Ostroff R, Gonzales M, Sanacora G. Antidepressant effect of ketamine during ECT. Am J Psychiatry. 2005 Jul;162(7):1385-6. doi: 10.1176/appi.ajp.162.7.1385. No abstract available.

  PMID: 15994728 BACKGROUND

• Rasmussen KG, Jarvis MR, Zorumski CF. Ketamine anesthesia in electroconvulsive therapy. Convuls Ther. 1996 Dec;12(4):217-23.

  PMID: 9034696 BACKGROUND

• White PF, Way WL, Trevor AJ. Ketamine--its pharmacology and therapeutic uses. Anesthesiology. 1982 Feb;56(2):119-36. doi: 10.1097/00000542-198202000-00007. No abstract available.

  PMID: 6892475 BACKGROUND

• Krystal AD, Weiner RD, Dean MD, Lindahl VH, Tramontozzi LA 3rd, Falcone G, Coffey CE. Comparison of seizure duration, ictal EEG, and cognitive effects of ketamine and methohexital anesthesia with ECT. J Neuropsychiatry Clin Neurosci. 2003 Winter;15(1):27-34. doi: 10.1176/jnp.15.1.27.

  PMID: 12556568 BACKGROUND

• Pigot M, Andrade C, Loo C. Pharmacological attenuation of electroconvulsive therapy--induced cognitive deficits: theoretical background and clinical findings. J ECT. 2008 Mar;24(1):57-67. doi: 10.1097/YCT.0b013e3181616c14.

  PMID: 18379337 BACKGROUND

• MacPherson RD, Loo CK. Cognitive impairment following electroconvulsive therapy--does the choice of anesthetic agent make a difference? J ECT. 2008 Mar;24(1):52-6. doi: 10.1097/YCT.0b013e31815ef25b.

  PMID: 18379336 BACKGROUND

• Dean RL, Hurducas C, Hawton K, Spyridi S, Cowen PJ, Hollingsworth S, Marquardt T, Barnes A, Smith R, McShane R, Turner EH, Cipriani A. Ketamine and other glutamate receptor modulators for depression in adults with unipolar major depressive disorder. Cochrane Database Syst Rev. 2021 Sep 12;9(9):CD011612. doi: 10.1002/14651858.CD011612.pub3.

  PMID: 34510411 DERIVED

• Loo CK, Katalinic N, Garfield JB, Sainsbury K, Hadzi-Pavlovic D, Mac-Pherson R. Neuropsychological and mood effects of ketamine in electroconvulsive therapy: a randomised controlled trial. J Affect Disord. 2012 Dec 15;142(1-3):233-40. doi: 10.1016/j.jad.2012.04.032. Epub 2012 Aug 2.

  PMID: 22858219 DERIVED

MeSH Terms

Interventions

Ketamine; Sodium Chloride

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Colleen K Loo, MB BS FRANZCP, MD

  University of New South Wales

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 16, 2008
• First Posted: May 20, 2008
• Study Start: April 1, 2008
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: March 29, 2013

Record last verified: 2013-03

Locations

AU (1)