Skip to content
lsd.com
CompletedPhase 1Results posted

Ketamine as an Adjunctive Therapy for Major Depression

NCT03256162 · KARMA-dep · St Patrick's Hospital, Ireland

Closed to entry
Status
Not accepting participants
Phase 1
Phase
25
Target enrolment
1
Study sites
Outside the US

What it is testing

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.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • The Hamilton Rating Scale for Depression-24 Item Version (HRSD-24)

    Measured over 15 weeks

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years
Ages
All
Sex
Not accepted
Healthy volunteers
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

Where

1 study site

FacilityCityRegionCountry
St Patrick's University HospitalDublin—Ireland

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT03256162 on ClinicalTrials.gov →

Last updated in the registry 2020-01-18. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits

Substance

All 4 trials from St Patrick's Hospital, Ireland →