F32
Conditions
Interventions
Group 1: Assessment of early visually evoked potentials
Group 2: Assessment of paired associative stimulation
Sponsors
Universitätsklinikum Freiburg
Eligibility
Sex/Gender
All
Age
20 Years to 50 Years
Inclusion criteria
Inclusion criteria: Treated depressive patients (sub-study 1) Inclusion criteria - Standard treatment, ketamine treatment, in each case as a treatment method selected according to clinical criteria as part of routine treatment - Patients from 18 to 65 years of age. - First-time or recurrent illness of a major depressive episode according to ICD-10 (F32.2 or F33.2), MADRS = 20 points. - 2 weeks prior stable psychopharmacotherapy. Healthy control subjects (all sub-studies) - Age 18-65 years - No intake of psychotropic substances (medication, drugs) at least 2 weeks before the PRAE measurement - No current or previous history of mental illness requiring treatment, no neurological disorders - No abuse of ketamine or benzodiazepines currently or in the past - No contraindications to the study medication used
Exclusion criteria
Exclusion criteria: Treated depressive patients (sub-study 1) - Comorbid psychotic or bipolar disorder. - Comorbid Axis II disorders: Confirmed emotionally unstable personality disorder of the borderline type (ICD-10: F60.3). - Comorbid trauma disorders: PTSD - Presence of acute substance dependence or substance abuse with less than 12 months of abstinence. - Previous non-medical abuse of ketamine. - Current treatment with benzodiazepines or pregabalin, opioids, Z-substances. - Previous treatment with benzodiazepines > 4 half-lives. - Simultaneous participation in other stimulation procedures (ECT, rTMS, THS, VNS).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in the amplitudes of the early visual evoked potentials (VEP) after optical stimulation or the motor evoked potentials after PAS or PAS-DCS - in each case before the start and after the end of the fast-acting treatment measures (test time 7 days before the start and 8 hours after the end of the intervention) - in healthy subjects without treatment measures; to check the temporal stability of the plasticity induction, two measurements at intervals of one week. - in untreated depressive patients (single measurement) - in healthy volunteers sequentially first without and then after application of lorazepam and ketamine (randomized; VEP/DCS-LTP measurements). | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in serum Brain Derived Neurotrophic Factor (BDNF) concentration before the start and 8 hours after the end of the intervention. Changes in DNA methylation of relevant candidate genes, e.g. the promoter region of the BDNF gene before the start and 8 hours after the end of the intervention. Change in the Beck Depression Inventory (BDI) before and after the respective treatment Change in the directionality of the influence in the form of directed coherence between combinations of NIRS channels over the PFC as a measure of its rostro-caudal hierarchical organization; collected before and after substance administration and after VEP/DCS-LTP Approximation rate in the AA task as a function of loss probability and loss level | — |
Countries
Germany
Contacts
Public ContactViktoria Galuba
UNIVERSITÄTSKLINIKUM FREIBURG
Outcome results
None listed