Status:
TERMINATED
Ketamine Interleaved With Electroconvulsive Therapy for Depression
Lead Sponsor:
St Patrick's Hospital, Ireland
Conditions:
Depression
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 epi...
Detailed Description
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 invit...
Eligibility Criteria
Inclusion
- ≥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
- 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
Key Trial Info
Start Date :
January 6 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 3 2020
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT04082858
Start Date
January 6 2020
End Date
June 3 2020
Last Update
September 9 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
St Patrick's University Hospital
Dublin, Co. Dublin, Ireland, D08 K7YW