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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00680433
Registration number
NCT00680433
Ethics application status
Date submitted
16/05/2008
Date registered
20/05/2008
Date last updated
29/03/2013
Titles & IDs
Public title
Ketamine as an Anaesthetic Agent in Electroconvulsive Therapy (ECT)
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Scientific title
A Double-blind Randomised, Placebo-controlled Study of Adjunctive Ketamine Anaesthesia in ECT (Electroconvulsive Therapy)
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Secondary ID [1]
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HREC 07281
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Major Depressive Episode
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Ketamine
Treatment: Drugs - Saline
Experimental: Active - Ketamine
Placebo comparator: Placebo - Saline (placebo)
Treatment: Drugs: Ketamine
Ketamine IV will be administered after the administration of the normal anaesthetic agents for ECT.
Treatment: Drugs: Saline
Saline (placebo) will be administered after the normal anaesthetic agents in ECT.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Memory tests
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Assessment method [1]
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Timepoint [1]
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Before ECT, after 6 ECT treatments, at the end of the ECT course
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Secondary outcome [1]
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Depression rating scale
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Assessment method [1]
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Timepoint [1]
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Before ECT, after each week of treatment, at the end of the ECT course
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Eligibility
Key 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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 4
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/04/2008
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/10/2012
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Sample size
Target
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Accrual to date
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Final
83
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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Wesley Hospital - Sydney
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Recruitment postcode(s) [1]
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2217 - Sydney
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Funding & Sponsors
Primary sponsor type
Other
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Name
Northside Clinic, Australia
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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Wesley Mission
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT00680433
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Trial related presentations / publications
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. 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. Rasmussen KG, Jarvis MR, Zorumski CF. Ketamine anesthesia in electroconvulsive therapy. Convuls Ther. 1996 Dec;12(4):217-23. 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. 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. 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. 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.
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Public notes
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Contacts
Principal investigator
Name
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Colleen K Loo, MB BS FRANZCP, MD
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Address
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University of New South Wales
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Fax
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Email
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Contact person for public queries
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT00680433
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