The Role of mTOR (Mammalian Target of Rapamycin) Signaling Pathway in the Antidepressive Effect of Ketamine in Patients with Depressive Disorder. - D-KET-mTOR

Prague Psychiatric Centre0 个研究点开始时间: 2013年3月12日最近更新: 2016年3月14日

试验速览

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•1. Men and women at the age between 18 to 65 years, with dextromanual dominance, t.j. scores 100 in Edinburgh Handedness Inventory (EHI).
•2. Patients have to answer DSM IV criteria for the major depressive episode, without psychotic symptoms, on the clinical investigation basis, by Mini international neuropsychiatry interview (M.I.N.I., Czech version 5.0.0.) - structured interview for psychiatric disorders on axis I based on DSM- IV.
•3. Input score in MADRS (Montgomery-Asberg Depression Rating Scale) higher than 20, what matches medium severity of clinical state in CGI (ClinicalGlobal Impression ) scale higher or equal with 4.
•4. Mental ability understand and sign informed consent.
•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) no
•F.1.3.1 Number of subjects for this age range

•1. Increased vulnerability to the development of psychosis ascertained on the basis a) M.I.N.I., b) family anamnesis of psychosis at relatives I. and II. degree.
•2. Presence of another psychiatric disorder on axis I base on DSM- IV less than 6 months before inclusion to the study.
•3. Contraindication for ketamine administration (hypertension, heart defect, severe cardiovascular disease, cerebrovascular accident in anamnesis, intracranial hypertension, glaucoma, hyperthyreosis, convulsions in anamnesis).
•4. Using of drugs with strong anticholinergic efect.
•5. Pregnant women, breastfeeding women or women without appropriate contraception.
•6. Electroconvulsive treatment in the last 2 months before visit 1.
•7. Treatment augmentation by lamotrigine, lithium, clozapine or IMAO (inhibitor of monoaminooxidase) in the last 2 weeks before visit 1.
•8. Pharmaceuticals, illness and states, which may have influence on EEG (benzodiazepines, classical antipsychotics, head injury, encephalitis, epilepsy, etc.).
•9. Clinically assessed serious suicidal risk.

发起方

Prague Psychiatric Centre