F33 F32
Conditions
Interventions
Group 1: Non-personalized, accelerated rTMS over the left DLPFC for 1 week followed by 6 weeks of psychotherapy.
Group 2: Personalized treatment with rTMS over one week according to the network dysfun
Sponsors
Klinik für Psychiatrie, Psychotherapie und Psychosomatik, Uniklinik RWTH Aachen
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: - Diagnosis of major depression (based on DSM-5 criteria) (MADRS > 20) - Written informed consent after comprehensive information about the study - Clinical condition sufficiently stable so that psychotropic medication can remain unchanged for at least two weeks prior to study entry and throughout the entire study period
Exclusion criteria
Exclusion criteria: - Current substance use disorder, schizophrenia, or psychotic depression - Acute suicidality (scores of 4 or 5 on the C-SSRS scale) - Cognitive impairment (scores below 26 on the MoCA test) - Cardiac instability - Contraindications to MRI, e.g. pacemakers or ferromagnetic implants - Contraindications to CBT (cognitive behavioral therapy) - Pregnancy and breastfeeding - Individuals who are hospitalized under a mental health order/act (involuntarily hospitalized patients)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Investigating whether altered network function is predictive of treatment response. Hypothesis: In the overall sample, more pronounced alterations in network function (at baseline) will predict a better response to the combined treatment with rTMS and psychotherapy. | — |
Secondary
| Measure | Time frame |
|---|---|
| Examining whether normalization of network dysfunction and improvement in depression severity induced by iTBS are more pronounced with personalized target selection compared to non-personalized stimulation. Analyzing whether targeted iTBS-augmented psychotherapy yields stronger effects on network (re-)organization and clinical improvement than non-targeted iTBS. Both direct effects in the stimulated brain regions and indirect effects mediated by changes in functional connectivity between the stimulated regions and other brain areas relevant to the respective biotypes will be considered. Investigating whether patients with low-grade inflammatory states and alterations in neuroplasticity-related factors show differential responses to rTMS. | — |
Countries
Germany
Contacts
Public ContactThomas Frodl
Klinik für Psychiatrie, Psychotherapie und Psychosomatik, Uniklinik RWTH Aachen
Outcome results
None listed