Clinical TrialMajor Depressive Disorder (MDD)KetamineCompleted

Clinical and neurobiological predictors of response to ketamine: towards personalized treatment of depression

Open-label Phase III single-arm study (n=40) evaluating neurobiological and clinical predictors of antidepressant response to a single ketamine infusion in patients with moderate–severe depression without psychotic symptoms.

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Target Enrollment
40 participants
Study Type
Phase III interventional
Design
Non-randomized

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Compound research: KetamineTopic research: Major Depressive Disorder (MDD)Research in Czechia

Detailed Description

Open-label, single-site study in the Czech Republic assessing whether baseline measures of anhedonia, neurophysiology (EEG/eLORETA) and inflammatory and kynurenine-pathway biomarkers predict antidepressant response to intravenous ketamine in patients with moderate to severe depression.

Primary outcome compares baseline anhedonia between responders and non-responders and correlates change in anhedonia with reduction in depressive symptoms (MADRS) at days 1, 4, 6 and follow-up at day 20; secondary measures include plasma kynurenine metabolites, D-serine, proinflammatory cytokines and electrophysiological correlates during and after infusion.

Study Protocol

Preparation

sessions

Dosing

1 sessions

Integration

sessions

Therapeutic Protocol

Manualized psychotherapy included

Study Arms & Interventions

Ketamine

experimental

Single intravenous ketamine infusion (Calypsol) administered as per study protocol to patients with moderate–severe depression; open-label single-arm design.

Interventions

  • Ketamine
    via IV• single dose

    Calypsol (ketamine hydrochloride 50 mg/ml) intravenous infusion; specific dose/regimen per protocol (not specified in public record).

Participants

Ages
18 – 65
Sexes
Male & Female

Inclusion Criteria

  • Men and women aged 18–65 years.
  • Moderate to severe depression without psychotic symptoms; current depressive episode duration ≥4 weeks and ≤2 years.
  • MADRS score >20; CGI ≥4.
  • At least one prior unsuccessful adequate antidepressant treatment in the current episode.
  • Stable dose of antidepressants for ≥1 month and clinically appropriate to continue during trial.
  • Mental competence to understand and sign informed consent.

Exclusion Criteria

  • Increased vulnerability to psychosis based on MINI (including past episodes) or family history of psychosis up to second-degree relatives.
  • Presence of comorbid Axis I psychiatric disorder per ICD-10 (except F32.1-2, F33.1-2) within 6 months prior to enrolment, including substance use disorders or abstinence <2 years (except nicotine).
  • Substantial suicidal risk as judged by the treating psychiatrist.
  • Personality disorder that would impede participation.
  • Somatic contraindications to ketamine: severe arterial hypertension (WHO stage 2+), congestive heart failure or other severe cardiovascular disease, history of stroke, intracranial hypertension, glaucoma, history of pre-eclampsia/eclampsia, untreated or decompensated thyroid 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 trial.
  • Concomitant augmentation with lamotrigine, lithium, clozapine or MAOi within 2 weeks prior to first visit.
  • Medications or conditions that significantly affect EEG (typical antipsychotics, prior cranial trauma, encephalitis, epilepsy, etc.), ECT within 2 months prior to infusion, or left-handedness.
  • Pregnancy, breastfeeding or lack of adequate contraception.

Study Protocol, Arms & Participants

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Study Details

Locations

Czechia

Recent activity

  • CompletedClinical and neurobiological predictors of response to ketamine: towards personalized treatment of dep… (2018-001539-39, ketamine)
  • StartedClinical and neurobiological predictors of response to ketamine: towards personalized treatment of dep… (2018-001539-39, ketamine)

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