Metabolic Profiling of Esketamine Treatment in Depressive Disorder

ConditionMajor Depressive Disorder

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18-70

SponsorUniversity of Zagreb

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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).

Trial population

Clinical Hospital Centre patients

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

Esketamine
Drug
nasal

Treatment groups

100 Participants

are divided into 2 treatment groups

Group A: patients receiving esketamine1 intervention

Group B: healthy controls0 interventions

Trial outcomes

Primary outcomes

changed metabolomics

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.

Time frame

8 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Zagreb

Lead sponsor

Source ClinicalTrials.gov

Apply now