TerminatedPhase 1ketamine

Ketamine Interleaved With Electroconvulsive Therapy for Depression

NCT ID

NCT04082858

Target Enrollment

3 participants

Start Date

2020-01-06

Est. Completion

2020-06-03

About This Study

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.

Conditions Studied

Depression

Interventions

•Ketamine
•Midazolam

Eligibility

Age:18 Years - N/A

Healthy Volunteers:No

View full eligibility 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

Study Locations (1)

St Patrick's University Hospital

Dublin, Co. Dublin, Ireland