TerminatedPhase 1

Ketamine Interleaved With Electroconvulsive Therapy for Depression

NCT04082858 · St Patrick's Hospital, Ireland

Closed to entry

Status

Not accepting participants

Phase 1

Phase

Target enrolment

Study sites

Outside the US

What it is testing

Summary

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.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

Montgomery Asberg Depression Rating Scale (MADRS)
Measured over 18 weeks

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years

Ages

All

Sex

Not accepted

Healthy volunteers

Inclusion Criteria: * ≥18 years old * Able to provide informed consent * Voluntary admission for treatment of an acute depressive episode * Meet DSM-V criteria for a major depressive disorder (MDD) and bipolar affective disorder (current episode depression) * Montgomery Asberg Depression Rating Scale 10 item version (MADRS) score of ≥20 * Referred for treatment with ECT * Sufficiently physically healthy to receive ketamine/midazolam and ECT Exclusion Criteria: * Inability to provide informed consent * Current involuntary admission * History of Axis 1 diagnosis other than major depression * Medical condition rendering unfit for ECT * Active suicidal intention * Presence of major neurological or organic brain disorder * Alcohol/substance dependence in previous six-months * Pregnancy or inability to confirm use of adequate contraception during the trial * Breastfeeding women * Contraindications to ketamine * Contraindications to midazolam

Where

1 study site

Facility	City	Region	Country
St Patrick's University Hospital	Dublin	Co. Dublin	Ireland

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT04082858 on ClinicalTrials.gov →

Last updated in the registry 2021-09-09. Registry records change; this page reflects the data build of 2026-08-25.

Where this trial sits

Substance

Ketamine

Indication

Depression120

All 4 trials from St Patrick's Hospital, Ireland →