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Trial NCT00680433

Resource URI: http://static.linkedct.org/resource/trials/NCT00680433
linkedct:arm_group <http://static.linkedct.org/resource/arm_group/32688>
linkedct:arm_group <http://static.linkedct.org/resource/arm_group/57846>
linkedct:brief_title Ketamine as an Anaesthetic Agent in Electroconvulsive Therapy (ECT)
linkedct:collaborator_agency <http://static.linkedct.org/resource/collabagency/8211>
linkedct:condition <http://static.linkedct.org/resource/condition/7675>
linkedct:criteria 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
linkedct: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. 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. This entry gives details of the main clinical trial: The effects of ketamine across a course of ECT.
linkedct:download_date Information obtained from ClinicalTrials.gov on December 30, 2009
linkedct:eligibility_gender Both
linkedct:eligibility_healthy_volunteers No
linkedct:eligibility_maximum_age N/A
linkedct:eligibility_minimum_age 18 Years
linkedct:end_date December 2010
linkedct:enrollment 34 (xsd:int)
linkedct:firstreceived_date May 16, 2008
linkedct:has_dmc No
linkedct:id NCT00680433
linkedct:intervention <http://static.linkedct.org/resource/intervention/112742>
linkedct:intervention <http://static.linkedct.org/resource/intervention/41761>
rdfs:label Trial NCT00680433
linkedct:lastchanged_date January 26, 2009
linkedct:lead_sponsor_agency Northside Clinic, Australia
linkedct:location <http://static.linkedct.org/resource/location/3603>
linkedct:nct_id NCT00680433
linkedct:number_of_arms 2 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:official_title A Double-Blind Randomised, Placebo-Controlled Study of Adjunctive Ketamine Anaesthesia in ECT (Electroconvulsive Therapy)
linkedct:org_study_id HREC 07281
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/10427>
linkedct:overall_status Enrolling by invitation
linkedct:oversight <http://static.linkedct.org/resource/oversight/75>
linkedct:oversight <http://static.linkedct.org/resource/oversight/81>
foaf:page <http://clinicaltrials.gov/show/NCT00680433>
linkedct:phase Phase 4
linkedct:primary_completion_date December 2010
linkedct:primary_outcomes <http://static.linkedct.org/resource/primary_outcomes/58452>
linkedct:reference <http://static.linkedct.org/resource/reference/16146>
linkedct:reference <http://static.linkedct.org/resource/reference/27565>
linkedct:reference <http://static.linkedct.org/resource/reference/31343>
linkedct:reference <http://static.linkedct.org/resource/reference/36009>
linkedct:reference <http://static.linkedct.org/resource/reference/36010>
linkedct:reference <http://static.linkedct.org/resource/reference/44063>
linkedct:reference <http://static.linkedct.org/resource/reference/51634>
linkedct:secondary_outcomes <http://static.linkedct.org/resource/secondary_outcomes/34852>
linkedct:source Northside Clinic, Australia
linkedct:start_date April 2008
linkedct:study_design Treatment, Randomized, Double Blind (Subject, Caregiver, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
linkedct:study_type Interventional
linkedct: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.
rdf:type linkedct:trials
linkedct:verification_date January 2009