A study searching for the factors predicting ketamine´s antidepressant effect
- Conditions
- Moderate to severe depression without psychotic symptomsTherapeutic area: Psychiatry and Psychology [F] - Psychological processes [F02]
- Registration Number
- EUCTR2018-001539-39-CZ
- Lead Sponsor
- árodní ústav duševního zdraví
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 40
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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method