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NCT Number: NCT07002684

Metabolic Profiling of Esketamine Treatment in Depressive Disorder

Major depressive disorder (MDD) is one of the most common psychiatric disorders, characterized by extremely high prevalence, relapse rate and therapeutic resistance. Treatment with ketamine and its enantiomer esketamine is the next step towards the successful treatment and understanding of depression that is resistant to treatment with standard antidepressants. The proposed study will include approximately 50 patients with MDD and 50 healthy control subjects of both sexes. Using untargeted metabolomic approach, we plan to detect changes in biochemical pathways related to the diagnosis of treatment-resistant MDD and changes related to the mechanism of action of esketamine. The proposed research will contribute to further understanding of the mechanism of action of esketamine in patients with MDD. Metabolic changes will be associated with improvements in specific domains of depressive symptoms and symptom severity in subjects with treatment-resistant major depressive disorder.

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Key information

Conditions

Major Depressive Disorder Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

  • 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.

Treatment and study plan

Esketamine

Drug

nasal

Primary outcomes

  1. changed metabolomics

    Time frame: 8 weeks

    Using a non-targeted metabolomic approach, investigate changes in biochemical pathways related to the mechanism of action of the drug esketamine in patients with treatment-resistant major depressive disorder.

Study contacts

Contact information is provided by the study sponsor or research team.

Tea Fabijanić, MD

CONTACT

[email protected]

+385915698801

Sponsors and collaborators

Lead sponsor

University of Zagreb

Other

Registry information

Official study title

Metabolic Profiling of Esketamine Treatment in Major Depressive Disorder

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jun 3, 2025
Registry last updated
Jun 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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