EUCTR2018-001539-39-CZ
Active, Not Recruiting
Phase 1
Clinical and neurobiological predictors of response to ketamine: towards personalized treatment of depression
árodní ústav duševního zdraví0 sites40 target enrollmentMay 31, 2018
DrugsCalypsol
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- árodní ústav duševního zdraví
- Enrollment
- 40
- Status
- Active, Not Recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
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
Outcomes
Primary Outcomes
Not specified
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