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
| Condition(s) | Major Depressive Disorder |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| Summary | 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 wit |
| Who can participate | 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, |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Accepts healthy volunteers | Yes |
| Lead sponsor | University of Zagreb |
| Locations | Zagreb, Croatia |
| Start date | 2023-04-01 |
| NCT ID | NCT07002684 |
| Official listing | https://clinicaltrials.gov/study/NCT07002684 |