Moderate to severe depression without psychotic symptoms
Conditions
Interventions
Trade Name: Calypsol
Pharmaceutical Form: Concentrate and solvent for solution for injection/infusion
INN or Proposed INN: Ketamine
Other descriptive name: KETAMINE HYDROCHLORIDE
Concentration unit: m
Sponsors
Národní ústav duševního zdraví
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Men and women aged 18 to 65 years old Moderate to severe depression without psychotic symptoms, current depressive episode at least 4 weeks and no more than 2 years of duration MADRS score more than 20, CGI 4 or more At least one previous, unsuccessful, adequate treatment for major depression in current episode Stable dose of antidepressants for at least 1 month and clinically appropriate to continue during trial Mental competence to understand and sign the 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 40 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Increased vulnerability to psychosis based on a) M.I.N.I. (including past episodes), b) family history of psychosis up to second degree relatives The presence of comorbid psychiatric disorder on Axis I within the criteria of ICD 10 F 0.X – F 99.X, except F 32.1-2, F 33.1/2 less than 6 months prior to enrollment in the study, including drug or alcohol addiction or abstinence for less than 2 years Substantial suicidal risk as judged by the treating psychiatrist Personality disorder that makes participation in the trial difficult Somatic contraindications for the administration of ketamine: severe arterial hypertension (WHO stage 2 and above), congestive heart failure or other severe cardiovascular disease, history of stroke, intracranial hypertension, glaucoma, history of preeclampsia or eclampsia, untreated or decompensated thyroid gland disease, history of seizures History of autoimmune or rheumatologic disease, undergoing biological therapy, chronic infectious disease or severe acute infection within 2 months prior to the trial Concomitant treatment augmentation with lamotrigine, lithium, clozapine or MAOi (monoamine oxidase inhibitor) within the previous 2 weeks before the first visit Medications and/or diseases, that can significantly affect EEG (typical antipsychotics, cranial trauma, encephalitis, epilepsy, etc.), history of electroconvulsive treatment in the 2 month prior to infusion and left-handedness Pregnancy, breastfeeding or the absence of adequate contraception
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine whether ketamine responders differ from non-responders in baseline parameters of anhedonia and to what extent does the change in anhedonia after ketamine administration correlate with the reduce in depressive symptomatology.;Secondary Objective: To compare baseline plasmatic levels of kynurenine pathway metabolites, D-serine and proinflammatory cytokines between responders and non-responders to ketamine. To assess the electrophysiological correlates of ketamine response using eLORETA (Exact Low Resolution Brain Electromagnetic Tomography) and to determine their predictive potential. To estimate the influence of several demographic and clinical variables, such as age, sex, anxiety, family history of alcohol abuse, and assess their predictive potential. ;Primary end point(s): To determine whether ketamine responders differ from non-responders in baseline parameters of anhedonia and to what extent does the change in anhedonia after ketamine administration correlate with the reduce in depressive symptomatology. ;Timepoint(s) of evaluation of this end point: Anhedonia will be evaluated before ketamine administration (day -1) and after the infusion (day 4). Depressive symptomatology will be evaluated before the infusion (day -1) followed by controls at day 1, day 4 and day 6. Both parameters will be evaluated also during the follow-up visit on day 20. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. To compare baseline plasmatic levels of kynurenine pathway metabolites, D-serine and proinflammatory cytokines between responders and non-responders to ketamine. 2. To assess the electrophysiological correlates of ketamine response using eLORETA (Exact Low Resolution Brain Electromagnetic Tomography) and to determine their predictive potential. 3. To estimate the influence of several demographic and clinical variables, such as age, sex, anxiety, family history of alcohol abuse, and assess their predictive potential. 4. To estimate the influence of cognitive processing speed on ketamine response. ;Timepoint(s) of evaluation of this end point: 1. Blood samples will be taken before the ketamine infusion (day 0), during the infusion and after the application (at day 4) 2. EEG will be registered before the ketamine infusion (day 0), during the infusion and after the application (at day 4) 3. Demographic variables will be evaluated at baseline (day -7 to -2), anxiety will be evaluated before (day -1) and after the infusion (day 1,4,6) 4. Cognitive processing will be tested before (day -1) and after (day 4) the infusion | — |
Countries
Czech Republic
Contacts
Public ContactClinical Trials Information
Národní ústav duševního zdraví
Outcome results
None listed