Clinical trial NCT02414932: Ketamine for Depression Relapse Prevention Following ECT
Official title: Ketamine for Depression Relapse Prevention Following ECT: a Randomised Pilot Trial With Blood Biomarker Evaluation
Conditions: Depression
Summary: Depression affects up to 20% of people in their lifetime and can be a severe debilitating illness. Indeed, the World Health Organisation has estimated that depression will soon be the second leading contributor to the burden of disease worldwide. One of the big problems for patients and doctors is that currently available antidepressant drugs and psychotherapies do not work for 30% of people. However, about 60% of such treatment-resistant patients will recover fully with electroconvulsive therapy (ECT). Even though it was developed over 75 years ago, ECT continues to be the most powerful treatment for severe, often life-threatening, depression. Despite that, we have recently reported that severe depression symptoms return (called a "relapse") in nearly 40% of such responders within six months of completing a course of ECT. Actually, such high relapse rates are seen for all patients with treatment-resistant depression, irrespective of what treatment they have received. There is thus an urgent need for better treatments to prevent relapse and one such possibility is an old drug called ketamine. Ketamine blocks the activity of glutamate, one of the major chemical messenger systems in the brain. Because of this effect it is sometimes used as an anaesthetic but it can also make you feel a bit "high" and so is sometimes abused as a recreational drug. Fortunately, in small doses it is quite safe. Recently, it has been found that ketamine has a remarkably rapid, but brief, antidepressant effect, including reducing suicidal thoughts. We wish to evaluate ketamine as a way to reduce relapse rates in people who have just been treated successfully with ECT for severe depression. Developing such a new treatment, and understanding how it works, would be of tremendous benefit to persons with severe depression, their families, and the wider society.
Interventions:
description: Ketamine hydrochloride 0.5 mg/kg; Pfizer Healthcare Ireland
name: Ketamine
other_name: Ketalar
type: Drug
description: Midazolam 0.045 mg/kg; Roche Products Ireland Ltd
name: Midazolam
other_name: Hypnovel
type: Drug
Study arms:
design_group_description: Ketamine (ketamine hydrochloride 0.5 mg/kg; Pfizer Healthcare Ireland)) will be made up as a 50 ml colourless saline solution and administered as a slow infusion over 40 minutes using an intravenous infusion pump. A course of up to four once-weekly infusions will be administered. Infusions will be discontinued by the Anaesthetist if there are persisting haemodynamic changes (i.e. heart rate >110/minute or systolic/diastolic blood pressure (BP) >180/100 or >20% increase above pre-infusion BP for more than 15 minutes) that do not respond to beta-blocker therapy.
design_group_title: Ketamine
design_group_type: Experimental
design_group_description: Midazolam (0.045 mg/kg; Roche Products Ireland Ltd) will be made up as a 50 ml colourless saline solution and administered as a slow infusion over 40 minutes using an intravenous infusion pump. A course of up to four once-weekly infusions will be administered.
design_group_title: Midazolam
design_group_type: Active Comparator
Sponsor: St. Patrick's University Hospital
Collaborators: Health Research Board
Drug name mappings:
name: 盐酸氯胺酮
lang: CN
name: Ketamine Hydrochloride
lang: EN
name: ケタミン塩酸塩
lang: JP