Ketamine Interleaved With Electroconvulsive Therapy for Depression

• Status: Terminated
• Trial end date: 2020-06-03
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: St Patrick's Hospital, Ireland
• Treatments: Ketamine; Midazolam

Criteria

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