Clinical TrialTreatment-Resistant Depression (TRD)EsketamineRecruiting

Metabolic Profiling of Esketamine Treatment in Depressive Disorder

This observational trial (n=100) will study the metabolic effects of esketamine (administered nasally) in patients with treatment-resistant major depressive disorder (TRD) and healthy controls, using an untargeted metabolomic approach.

Target Enrollment
100 participants
Study Type
Phase NA observational
Design
Non-randomized

Detailed Description

Major depressive disorder (MDD) is common and often treatment-resistant; this prospective observational study will enrol ~50 patients with TRD and ~50 healthy controls to profile metabolomic changes associated with esketamine treatment.

Using untargeted metabolomics, the study aims to identify biochemical pathway changes related to diagnosis and to esketamine's mechanism of action, and to associate metabolic changes with improvements in depressive symptom domains and severity.

Patients receive intranasal esketamine as part of treatment; healthy controls provide comparison samples without intervention.

Study Arms & Interventions

Esketamine

experimental

Patients receiving esketamine (nasal)

Interventions

  • Esketamine
    via Other• as clinically indicated

    nasal administration; dose per clinical care

Healthy controls

waitlist

No intervention

Participants

Ages
18 – 70
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • for healthy control participants: 18-70 years, both sexes, without psychiatric drugs
  • for patients: from 18-70 years, both sexes, failed treatment attempts with at least two antidepressants of the appropriate dose and duration.

Exclusion Criteria

  • Exclusion Criteria:
  • for patients: treatment with tryptophan, St. John's wort, and/or opioid analgesics in the last month, daily intake of benzodiazepines;
  • for all participants: presence of psychotic symptoms, alcohol and/or drug addiction, disorder seizures, eating disorder, dementia and other neurodegenerative diseases, epilepsy, intellectual disabilities, severe somatic diseases (including insufficiently controlled arterial hypertension, diabetes and thyroid diseases), active psychotherapeutic treatment (except supportive psychotherapy, which is an integral part of every psychiatric treatment and will be the same in all groups of respondents).
  • Participants will be excluded if they follow a weight loss diet or take weight loss medication, are pregnant or breastfeeding.

Study Details

Locations

Tea Fabijanić — Zagreb, Croatia

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