F32.2 F33.2
Conditions
Interventions
Group 1: Depressed Patients - treatment as usual (TAU)
In randomized order SIGMA or MBI as intervention
Group 2: Depressed Patients treated with ketamine
In randomized order SIGMA or MBI as interventi
Sponsors
Universitätsklinikum Freiburg
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: - Patients from 18 to 65 years of age (amendment) (untreated or treated) - First-time or recurrent illness of a major depressive episode according to ICD-10 (F32.2 or F33.2) and/or outpatient treatment (amendment), ketamine treatment or rTMS treatment, healthy subjects without previous psychiatric/neurological illnesses or amendment: patients who are treated with benzodiazepines as part of their routine treatment. - No change in psychopharmacotherapy 2 weeks prior.
Exclusion criteria
Exclusion criteria: - Bipolar disorder - Comorbid psychotic disorder. - Comorbid Axis II disorders: Confirmed emotionally unstable personality disorder of the borderline type (ICD-10: F60.3) - Comorbid trauma disorders: e.g. PTSD - Presence of acute substance dependence or substance abuse with less than 12 months of abstinence. - Previous use of ketamine as a narcotic drug. - Amendment: Current treatment with benzodiazepines or pregabalin, opioids, MAO inhibitors, Z-substances. - Previous treatment with benzodiazepines < 4 half-lives for the non-benzodiazepine group - Simultaneous participation in stimulation procedures (ECT, RTMS, THS, VNS). - Non-Caucasian ethnicity (due to the accompanying epigenetic studies) Exclusion criteria for helathy controls - As under exclusion criteria above - In addition: No mental illness requiring treatment currently or in the past, no neurological illnesses Number of study participants Amendment: 2 groups of 84 participants each (14 subjects per group, 14 patients treatment as usual, 14 patients untreated, 14 patients with rTMS treatment, 14 patients with ketamine treatment and 14 patients with benzodiazepine treatment)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| WHO-5 well-being-score before and after both interventions (SIGMA and MBI) calculated as the difference of the values in dependence of the corresponding plasticity state. | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in the PANAS (Positive and Negative Affect Schedule) 22 hours before and 2 hours after the intervention. Amendment: Changes in skin conductance and pulse variability during the interventions compared to 22 hours before and 2 hours after the interventions. Change in serum Brain Derived Neurotrophic Factor (BDNF) concentration 22 hours before the start and 2 hours after the end of the intervention. Epigenetic changes (DNA methylation changes) of relevant candidate genes, e.g. the promoter region of the BDNF gene 22 hours before the start and 2 hours after the end of the intervention. Beck Depression Inventory (BDI). | — |
Countries
Germany
Contacts
Public ContactViktoria Galuba
UNIVERSITÄTSKLINIKUM FREIBURG
Outcome results
None listed