CI

At a glance

ClinicalIndex Comparison Record
Early Ph 1Completed· 6 enrolled
Drug / intervention
Ketamine +1 moredrug
Likely dose
Ketamine 0.5 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02414932
NCT02414932Early Ph 1Completed

Ketamine for Depression Relapse Prevention Following ECT: a Randomised Pilot Trial With Blood Biomarker Evaluation

St Patrick's Hospital, Ireland·interventional·Posted Apr 13, 2015·Updated May 6, 2021

In Brief

A Early Phase 1 clinical trial evaluating Ketamine and Midazolam for Depression. Completed, enrolled 6 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDepression
CountriesIreland

Timeline

Early Ph 1CompletedFinished
201520162017201820192020202120222023202420252026
First PostedApr 13, 2015
Enrollment StartApr 1, 2015
Primary CompletionApr 7, 2017
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 11.2 years ago

Interventions

Ketaminedrug

Ketamine hydrochloride 0.5 mg/kg; Pfizer Healthcare Ireland

Midazolamdrug

Midazolam 0.045 mg/kg; Roche Products Ireland Ltd