Ketamine as an adjunctive therapy for Major Depression - a randomised controlled pilot trial: The KARMA-Dep Trial
- Conditions
- DepressionTherapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]
- Registration Number
- EUCTR2016-004764-18-IE
- Lead Sponsor
- St Patrick’s Mental Health Services
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 25
•=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
•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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method