EUCTR2011-001520-37-SEActive, not recruitingNot Applicable
Ketamine as an alternative to electroconvulsive therapy for treatment of major depressive disorder - KETECT
Skåne University Hospital, Malmö0 sitesStarted: May 24, 2012Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •ASA grade 1-3
- •Major depressive episode according to DSM-IV
- •Montgomery Asberg Depression Rating Scale (MADRS) = 20
- •Offered and accepted ECT
- •Understands and speaks swedish
- •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 194
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- •Reluctance to continued participation in the study
- •Inability to adequately participate in the study
- •Suspected serious adverse reaction
- •Known / suspected allergy to drugs to be used in the study
- •Comorbid psychiatric diagnosis that could interfere with treatment: primary psychotic disorder, personality disorder
- •Habitual speech, hearing, memory, or cognitive difficulties
- •Breastfeeding or anamnestic known / suspected pregnancy
- •Known / suspected ongoing or recent (within 6 months) drug abuse
- •Ongoing care of Compulsory Mental Care Act
- •Hypovolemia, dehydration or heart disease, especially coronary artery disease (eg, congestive heart failure, myocardial ischemia, and myocardial infarction) due to the significant increase in myocardial oxygen consumption.
- •Moderate hypertension and tachyarrhythmias
- •Elevated cerebrospinal pressure and injuries or diseases of the CNS.
- •Elevated intraocular pressure (e.g., glaucoma)
- •Acute intermittent porphyria.
- •Ongoing severe infection
Investigators
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