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
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Trial Details
Trial Number
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.