CompletedPhase 1ketamine

Ketamine as an Adjunctive Therapy for Major Depression

NCT ID

NCT03256162

Target Enrollment

25 participants

Start Date

2017-09-07

Est. Completion

2018-09-21

About This Study

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.

Conditions Studied

Major Depressive EpisodeUnipolar DepressionBipolar Depression

Interventions

•Ketamine
•Midazolam

Eligibility

Age:18 Years - N/A

Healthy Volunteers:No

View full eligibility 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

Study Locations (1)

St Patrick's University Hospital