ClinicalTrials.gov processed this data on March 27, 2024Link to the current ClinicalTrials.gov record.https://clinicaltrials.gov/ct2/show/NCT00680433HREC 07281NCT00680433Ketamine as an Anaesthetic Agent in Electroconvulsive Therapy (ECT)A Double-blind Randomised, Placebo-controlled Study of Adjunctive Ketamine Anaesthesia in ECT (Electroconvulsive Therapy)Northside Clinic, AustraliaOtherWesley MissionOtherNo
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.
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.
CompletedApril 2008October 2012October 2012Phase 4InterventionalNoRandomizedParallel AssignmentTreatmentTriple (Participant, Care Provider, Outcomes Assessor)Memory testsBefore ECT, after 6 ECT treatments, at the end of the ECT courseDepression rating scaleBefore ECT, after each week of treatment, at the end of the ECT course283Major Depressive EpisodeActiveExperimentalKetaminePlaceboPlacebo ComparatorSaline (placebo)DrugKetamineKetamine IV will be administered after the administration of the normal anaesthetic agents for ECT.ActiveDrugSalineSaline (placebo) will be administered after the normal anaesthetic agents in ECT.Placebo
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
All18 YearsN/ANoColleen K Loo, MB BS FRANZCP, MDPrincipal InvestigatorUniversity of New South WalesWesley HospitalSydneyNew South Wales2217AustraliaAustraliaMcDaniel 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: 10.1097/00124509-200606000-00005.16801824Ostroff 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.15994728Rasmussen KG, Jarvis MR, Zorumski CF. Ketamine anesthesia in electroconvulsive therapy. Convuls Ther. 1996 Dec;12(4):217-23.9034696White 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.6892475Krystal 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.15.1.27.12556568Pigot 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.0b013e3181616c14.18379337MacPherson 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.18379336March 2013May 16, 2008May 19, 2008May 20, 2008March 27, 2013March 27, 2013March 29, 2013Principal InvestigatorThe University of New South WalesColleen LooAssociate ProfessorKetamine