Pragmatic, randomised, controlled, parallel-group, pilot clinical trial of ketamine vs. midazolam interleaved with electroconvulsive therapy (ECT) as an adjunctive treatment for a major depressive episode. The main purpose of the pilot study is to assess trial processes to help inform a future definitive trial.
This trial was terminated due to inadequate recruitment as a result of COVID-19.
Topic Depression
Country Ireland
Visit trial
Status
Terminated
Results Published
Start date
19 December 2020
End date
09 September 2021
Chance of happening
0%
Phase
Phase I
Design
Blinded
Type
Interventional
Generation
First
Participants
24
Sex
All
Age
18- 99
Therapy
No
Trial Details
Patients referred for treatment with ECT at St Patrick's Mental Health Services for treatment of a depressive episode will be eligible for recruitment to the clinical trial. Participants will be invited to be randomised to a course of twice-weekly ketamine or midazolam infusions for the duration of ECT. Participants will receive the first allocated infusion following the first or second treatment with ECT. Block randomisation will be independently performed. Infusions will be delivered on separate days to ECT. Physical, psychotomimetic and cognitive outcomes will be monitored before, during and after infusions.Treatment-as-usual will continue throughout the entire trial. Trial Interventions: participants will receive twice-weekly infusions of either ketamine at 0.5mg/Kg or midazolam at 0.045mg/Kg. All infusions will be administered by a Consultant Anaesthetist. Repeated infusions of allocated drug have been shown to be safe and well tolerated by patients with mental illness. Minor haemodynamic changes and psychotomimetic side effects can occur and will be assessed regularly during infusions and for 120 minutes afterwards. Participants will be followed-up at six weeks and three months after the final infusion to assess for relapse according to standardised criteria.NCT Number NCT04082858
Sponsors & Collaborators
St Patrick's HospitalSt Patrick's University Hospital is a psychiatric hospital affiliated with Trinity College Dublin.
Measures Used
Quick Inventory of Depressive SymptomatologyThe Quick Inventory of Depressive Symptomatology (Self-Report) (QIDS-SR16) is a self-report tool designed to screen for depression and measure changes in the severity of symptoms.
Montgomery-Asberg Depression Rating Scale
A ten-item diagnostic questionnaire used to measure the severity of depressive symptoms in patients with mood disorders.
Clinical-Administered Dissociative Symptoms Scale
The Clinical-Administered Dissociative Symptoms Scale (CADSS) is a scale used to measure dissociative states such as those induced by ketamine.
Young Mania Rating Scale
The Young Mania Rating Scale (YMRS) is used to evaluate manic symptoms at baseline and over time. The scale consists of 11 items covering the core symptoms of the manic phase of bipolar disorder: mood, motor activity, interest in sex, sleep, irritability, speech, flight of ideas, grandiosity, aggressive behaviour, appearance, and an item regarding patient insight. Each item is given a severity rating, with a higher rating indicating more severe symptoms. Responses are the patient's subjective report of their clinical condition over the previous 48 hours.