EUCTR2018-003421-28-IEActive, not recruitingPhase 1
Ketamine interleaved with electroconvulsive therapy for depression, a pragmatic randomised controlled pilot trial (KITE-Dep) - KITE-Dep trial
St Patrick's Mental Health Services0 sites24 target enrollmentStarted: September 28, 2018Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 24
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
- •Able to provide informed consent
- •Voluntary admission for treatment of an acute depressive episode
- •Meet DSM-V criteria for a major depressive disorder (MDD) and bipolar affective disorder (current episode depression)
- •Montgomery Asberg Depression Rating Scale 10 item version (MADRS) score of =20
- •Referred for treatment with ECT
- •Sufficiently physically healthy to receive ketamine/midazolam and ECT
- •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 12
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 12
Exclusion Criteria
- •Inability to provide informed consent
- •Current involuntary admission
- •History of Axis 1 diagnosis other than major depression
- •Medical condition rendering unfit for ketamine/midazolam or ECT
- •Active suicidal intention
- •Presence of major neurological or organic brain disorder
- •Alcohol/substance dependence in previous six-months
- •Pregnancy or inability to confirm use of adequate contraception during the trial
- •Breastfeeding women
Investigators
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