EUCTR2016-004764-18-IEActive, not recruitingPhase 1
Ketamine as an adjunctive therapy for Major Depression - a randomised controlled pilot trial: The KARMA-Dep Trial - Karma-dep trial
St Patrick’s Mental Health Services0 sites25 target enrollmentStarted: November 30, 2016Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 25
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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 DSM-IV criteria for a major depressive disorder (MDD) and bipolar affective disorder (current episode depression)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 30
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
Exclusion Criteria
- •Current involuntary admission
- •Medical condition rendering unfit for ketamine/midazolam
- •Active suicidal intention
- •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
Investigators
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