F32 F33
Conditions
Interventions
Group 1: Schema therapy and bilateral verum theta burst stimulation (TBS).
Measurement points:
Screening (day -3 to 0) Information, inclusion/exclusion (Mini-DIPS, MADRS), neurological examination, c
demographics, BDI-II, GAF, SCID-5-AMPD, PDS-ICD-11, YSQ, PID5BFM, medical history, randomization
Visit 1 Day 1-5 (day 5)
GAF, BDI-II/MADRS, resting motor threshold (Gr. 1/2), TMS/ST (Gr. 1/2), AE query
Visit 2 Day 8-12 (Day 12)
GAF, BDI-II/MADRS, resting motor threshold, TMS/ST, AE.
Visit 3 Day 15-19 (Day 19)
GAF, BDI-II/MADRS, TMS/ST, AE.
Visit 4 Day 22-26 (Day 26)
Complete final measurements (MADRS, BDI, GAF, PDS-ICD-11, YSQ, PID5BFM).
Group 2: Schema therapy with bilateral sham (placebo) TBS.
Group 3: Schema therapy without verum or sham TBS.
Sponsors
LVR-Klinikum Düsseldorf
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: • Patients who are able and willing to follow all study procedures in accordance with the protocol (including having sufficient German language skills) • Diagnosis of depression recorded through a standardized clinical interview • Participation in inpatient or day-care standardized schema therapy treatment • No previous experience with schema therapy • If medicated, stable intake of medication in therapeutic dosage for two weeks prior to study/stimulation start • Medication should remain stable during the four-week stimulation phase Medication should remain stable during the four-week stimulation phase • Exclusion of pregnancy by beta HCG determination prior to inclusion in the study and willingness to use contraception for the duration of stimulation • Voluntary treatment • Capacity to consent; patients who are able and willing to give their written consent to participate in the study after receiving detailed information
Exclusion criteria
Exclusion criteria: • History of seizures (epilepsy) • Metallic foreign bodies in the skull area and pronounced tattoos in the head area • Significant brain malformations or tumors, cerebrovascular events, traumatic brain injury, neurodegenerative diseases, brain surgery, deep brain stimulation • Pacemaker • Severe physical illnesses • Other mental illnesses (recorded by Mini-DIPS-OA), except depression, anxiety disorder, or personality disorder • Acute suicidality (MADRS score > 4 for question 10) • No recent MRI ( 1 mg/day lorazepam or more • Existing legal guardianship with reservation of consent • Treatment with electroconvulsive therapy in the current episode • Current or previous treatment with deep brain stimulation, vagus nerve stimulation, other intracranial implants • Desire to become pregnant or lack of reliable contraceptive measures • Placement in an institution due to a court or official order
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint/target parameter: The primary endpoint is the change in depressive symptoms, measured in the external medical assessment using the Montgomery Asberg Depression Rating Scale (MADRS). In addition, the change in depressive symptoms is also assessed in the self-rating using the Beck Depression Inventory (BDI-II). These target parameters are directly related to the primary project goal, namely to assess the effectiveness of the combined therapy and to demonstrate that treatment with ST plus TBS results in a greater reduction in depressive symptoms than control interventions. Measurement points: Screening (day -3 to 0) Information, inclusion/exclusion (Mini-DIPS, MADRS), neurological examination, cMRT, laboratory. Baseline (visit 0) Day -3 to 0; demographics, BDI-II, GAF, SCID-5-AMPD, PDS-ICD-11, YSQ, PID5BFM, medical history, randomization Visit 1 Day 1-5 (day 5); GAF, BDI-II/MADRS, resting motor threshold (Gr. 1/2), TMS/ST (Gr. 1/2), AE query Visit 2 Day 8-12 (Day 12); GAF, BDI-II/MADRS, resting motor threshold, TMS/ST, AE. Visit 3 Day 15-19 (Day 19); GAF, BDI-II/MADRS, TMS/ST, AE. Visit 4 Day 22-26 (Day 26); Complete final measurements (MADRS, BDI, GAF, PDS-ICD-11, YSQ, PID5BFM). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints include improvement in overall functional level, measured using the Global Assessment of Functioning Scale (GAF), and the recording of specific changes in schema therapy patterns using the schema questionnaire. In addition, tolerability is assessed by systematically recording adverse events (AEs) and serious adverse events (SAEs). Overall, these endpoints enable a comprehensive assessment of the efficacy, functionality, and safety of the combined therapy in the context of the study. | — |
Countries
Germany
Contacts
Public ContactMilenko Kujovic
LVR-Klinikum Düsseldorf
Outcome results
None listed