Response to ketamine in patients with treatment-resistant depression Mental and Behavioural Disorders
Conditions
Interventions
All participants will receive intravenous ketamine as part of standard clinical treatment for treatment-resistant depression (TRD), administered 3 times per week (e.g., Monday, Wednesday, Friday), for
Sponsors
Department of Psychiatry of Faculty of Medicine, Comenius University and University Hospital Bratislava
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age between 18 and 65 years 2. Diagnosis of a current depressive episode according to ICD-10 criteria, including: F32.x – Depressive episode F33.x – Recurrent depressive disorder F31.x – Bipolar affective disorder, current episode depressive F41.2 – Mixed anxiety and depressive disorder 3. Body Mass Index (BMI) between 18.5 and 28 kg/m² 4. Eligible for treatment with intravenous ketamine as part of standard care for treatment-resistant depression 5. Ability and willingness to provide written informed consent
Exclusion criteria
Exclusion criteria: 1. History of organic brain damage or cerebrovascular accident 2. Current or past substance abuse or dependence 3. Diagnosed endocrinopathy (except for compensated hypothyroidism) 4. Pregnancy, lactation, or current hormone therapy 5. Presence of psychiatric diagnoses outside of the target ICD-10 categories, including: 5.1. Schizophrenia spectrum and other psychotic disorders (F20–F29) 5.2. Personality disorders (F60–F69) 5.3. Neurodevelopmental disorders 5.4. Any mental disorder not listed in inclusion criteria 6. Current corticosteroid treatment 7. Diagnosed autoimmune disease 8. Use of medications that affect the renin-angiotensin-aldosterone system, including: 8.1. ACE inhibitors 8.2. Angiotensin II receptor blockers (sartans) 8.3. Spironolactone
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Salivary aldosterone and cortisol concentrations and their diurnal rhythms (morning vs evening levels) 2. Hormone levels will be measured at baseline (before first infusion), after the third infusion, after the final infusion, and at 3-month follow-up. 3. Aldosterone will be measured using a modified radioimmunoassay (RIA) method; cortisol will be measured using a commercial ELISA kit. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Depressive symptom severity, assessed by the Montgomery–Åsberg Depression Rating Scale (MADRS) and the Patient Health Questionnaire (PHQ-9), measured at baseline, after the third infusion, after the final infusion, and at 3-month follow-up. 2. Salivary cortisol levels and rhythm, measured alongside aldosterone at all time points (baseline, post-third infusion, post-final infusion, and 3-month follow-up), assessed for trait-like stability. 3. Response to the dexamethasone suppression test (DST) in a subset of participants, assessed via salivary cortisol concentrations before and after 1 mg dexamethasone administration. | — |
Countries
Slovakia
Contacts
Public ContactLubomíra;Gabriela Izáková;Bezáková
;
Outcome results
None listed