Investigation of antidepressant efficacy of oral ketamine treatment

Medical University of Vienna0 个研究点目标入组 60 人开始时间: 2016年11月29日最近更新: 2021年11月29日

试验速览

暂无简介。

•(i)Diagnosis of a major depressive episode in the scope of a major depressive or bipolar disorder supported by a Structured Clinical Interview for DSM-IV-TR (SCID)
•(ii)Hamilton depression rating scale score = 19
•(iii)Willingness and competence to sign the informed consent form
•(iv)Age 18 to 64 years
•(v)Stable psychopharmacological treatment for 10 days (except benzodiazepines)
•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 60
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•(i)Initiation of a new antidepressant or mood stabilizing treatment (pharmacological, physical or psychotherapeutic) with adequate dosage (as defined by the minimum recommended dose in the respective prescribing information) within 4 weeks prior to inclusion.
•(ii)Prior use of ketamine
•(iii)Pregnancy/Breast feeding
•(iv)Instable arterial hypertension >170/110mmHg
•(v)Hepatic dysfunction
•(vi)Hyperthyreosis
•(vii)History of glaucoma
•(viii)Neurodegenerative disorders
•(ix)Any unstable medical illness
•(x)History of substance abuse within the past 12 months
•(xi)History of psychosis
•(xii)Failure to comply with the study protocol or to follow the instructions of the investigating team
•(xiii)Current treatment with one of the following drugs: clopidogrel, carbamazepine, valproate, barbiturates, memantine, modafinil, disulfiram, amiodarone, ranolazine, phenytoin, verapamil, fibrates, antiretroviral agents, antimicrobial chemotherapeutics, azole antifungals, glucocorticoids, cyclosporine, valeriana/garlic/grapefruit preparations, St. John’s wort.

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