Overview

Ketamine as an Adjunctive Therapy for Major Depression

Status:
Completed
Trial end date:
2018-09-21
Target enrollment:
0
Participant gender:
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 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
St Patrick's Hospital, Ireland
Treatments:
Ketamine
Midazolam
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