INCLUSION CRITERIA: 1. Men and women at the age between 18 to 65 years, with dextromanual dominance. 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. 3. Input score in MADRS Scale higher than 20, what matches medium severity of clinical state in CGI scale higher or equal with 4. 4. Mental ability to understand and sign informed consent.
Conditions
Interventions
Trade Name: CALYPSOL
Product Name: ketamine hydrochloride
Product Code: 05/140/97-C
Pharmaceutical Form: Intravenous infusion
INN or Proposed INN: KETAMINE HYDROCHLORIDE
CAS Number: 1867669
Current Sp
Sponsors
Prague Psychiatric Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 [60] 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 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1. to develop an overall diagnostic and treatment methods enabling the fastest and the most accurate recognition of early life-threatening states 2. to prevent from late diagnostics and treatment of functional brain disorders in affective disorders;Secondary Objective: Testing predictive values of prefrontal QEEG theta cordance in anti-depressive responds to single ketamine administration and simultaneous employment of eLORETA connectivity in monitoring functional brain changes during remission of depressive symptomps. ;Primary end point(s): Working hypothesis A. Prefrontal QEEG theta cordance decrease 45 minutes after single i.v. ketamine application in depressive patients correlates positively with a decrease in MADRS scale 72 hours after application. B. Prefrontal QEEG theta cordance decrease 45 minutes after single i.v. ketamine application in depressive patients correlates with a functional connectivity in the prefrontal cortexu and in the limbic structures 72 hours after application. | — |
Countries
Czech Republic
Outcome results
None listed