Overview
Ketamine as an Adjunctive Therapy for Major Depression
Status:
Completed
Completed
Trial end date:
2018-09-21
2018-09-21
Target enrollment:
0
0
Participant gender:
All
All
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 inform a future definitive trial.Phase:
Phase 1Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
St Patrick's Hospital, IrelandTreatments:
KetamineMidazolam
Criteria
Inclusion Criteria:- ≥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 Criteria:
- 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