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