- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00680433
Ketamine as an Anaesthetic Agent in Electroconvulsive Therapy (ECT)
A Double-blind Randomised, Placebo-controlled Study of Adjunctive Ketamine Anaesthesia in ECT (Electroconvulsive Therapy)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study will report on two related trials. In the outpatient trial, patients will be administered adjunctive ketamine at two different doses (0.25mg/kg; 0.5mg/kg), and a placebo (saline), across 3 consecutive sessions within their regular maintenance ECT course. The order of conditions will be randomised across participants. Patients will be required to learn some words and faces 20 minutes prior to ECT, and complete a detailed cognitive battery 4 hours after ECT on each of the 3 occasions. The purpose of this trial is to determine whether ketamine is superior to placebo in reducing cognitive impairment following ECT and what the optimal dose of ketamine is for minimising cognitive and other side effects. Projected sample for this trial is N = 17.
In the inpatient trial, patients will be randomly assigned to receive ketamine or placebo for the duration of the acute ECT course. Patients will be administered a detailed cognitive battery the day before commencing ECT treatment, the day after the 6th treatment, and 1-3 days and 1 month following the end of the acute ECT course. The purpose of this trial is to examine whether patients in the ketamine condition had superior cognitive outcomes to those in the placebo condition during and following a course of ECT. In addition, depressive symptomatology will be examined throughout the ECT course to determine whether ketamine anaesthesia during ECT has antidepressant, as well as, cognitive benefits. Projected sample for this trial is N = 34.
This entry gives details of the main clinical trial: The effects of ketamine across a course of ECT.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
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New South Wales
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Sydney, New South Wales, Australia, 2217
- Wesley Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Satisfy DSM-IV-TR criteria for Major Depressive Episode
- 18 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Active
Ketamine
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Ketamine IV will be administered after the administration of the normal anaesthetic agents for ECT.
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Placebo Comparator: Placebo
Saline (placebo)
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Saline (placebo) will be administered after the normal anaesthetic agents in ECT.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Memory tests
Time Frame: Before ECT, after 6 ECT treatments, at the end of the ECT course
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Before ECT, after 6 ECT treatments, at the end of the ECT course
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Depression rating scale
Time Frame: Before ECT, after each week of treatment, at the end of the ECT course
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Before ECT, after each week of treatment, at the end of the ECT course
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Colleen K Loo, MB BS FRANZCP, MD, University of New South Wales
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- Rasmussen KG, Jarvis MR, Zorumski CF. Ketamine anesthesia in electroconvulsive therapy. Convuls Ther. 1996 Dec;12(4):217-23.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics, Dissociative
- Anesthetics, Intravenous
- Anesthetics, General
- Anesthetics
- Excitatory Amino Acid Antagonists
- Excitatory Amino Acid Agents
- Ketamine
Other Study ID Numbers
- HREC 07281
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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