Ketamine as an Anaesthetic Agent in Electroconvulsive Therapy (ECT)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Double-blind Randomised, Placebo-controlled Study of Adjunctive Ketamine Anaesthesia in ECT (Electroconvulsive Therapy)

Conditions
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Major Depressive Episode

Intervention / Treatment
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* Drug: Ketamine
* Drug: Saline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active<br>Ketamine | Drug: Ketamine<br>* Ketamine IV will be administered after the administration of the normal anaesthetic agents for ECT.<br>|
| Placebo Comparator: Placebo<br>Saline (placebo) | Drug: Saline<br>* Saline (placebo) will be administered after the normal anaesthetic agents in ECT.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Memory tests |  | Before ECT, after 6 ECT treatments, at the end of the ECT course | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depression rating scale |  | Before ECT, after each week of treatment, at the end of the ECT course |