Status:
COMPLETED
Ketamine as an Adjunctive Therapy for Major Depression
Lead Sponsor:
St Patrick's Hospital, Ireland
Conditions:
Major Depressive Episode
Unipolar Depression
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
Randomised, controlled, parallel-group, pilot clinical trial of ketamine vs. midazolam as an adjunctive therapy for depression. The main purpose of the pilot study is to assess trial processes to help...
Detailed Description
Pragmatic, randomised, controlled, parallel-group, pilot trial. Trial participants will be patients admitted to St Patrick's University Hospital for treatment of a depressive episode. The investigator...
Eligibility Criteria
Inclusion
- ≥18 years old
- Hamilton Rating Scale for Depression-24 item version (HRSD-24) score of ≥21
- Voluntary admission for treatment of an acute depressive episode
- Meet Diagnostic and Statistical Manual of Mental Disorders , Fifth Edition (DSM-V) criteria for a major depressive disorder (MDD) and bipolar affective disorder (current episode depression)
Exclusion
- Current involuntary admission
- Medical condition rendering unfit for ketamine/midazolam
- Active suicidal intention
- Dementia
- History of Axis 1 diagnosis other than major depression
- Electroconvulsive Therapy (ECT) administered within the last two months
- Alcohol/substance dependence in previous six-months
- Pregnancy or inability to confirm use of adequate contraception during the trial
- Breastfeeding women
Key Trial Info
Start Date :
September 7 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 21 2018
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT03256162
Start Date
September 7 2017
End Date
September 21 2018
Last Update
January 18 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
St Patrick's University Hospital
Dublin, Ireland, D8