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Recruiting
NCT07889739
Sensation Seeking and TMS Response in TRD
Conditions: MDD, Severe Depression, Major Depressive Episode
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 100
Sponsor: Technical University of Munich
Location: Technical University of Munich, TUM School of Medicine and Health, Department of Psychiatry and Psychotherapy, München Bavaria
Summary
his real-world observational study examines whether sensation-seeking personality traits influence the clinical response to transcranial magnetic stimulation (TMS) in patients with treatment-resistant depression (TRD). Participants will complete a validated sensation seeking scale prior to TMS treatment, and depressive symptoms will be assessed using standardized clinical scales during and after the TMS course.
Eligibility Criteria
Inclusion Criteria:
* Adults (≥18 years).
* Diagnosis according to ICD-10: recurrent depressive disorder, severe depressive disorder, schizoaffective disorder (depressive episode) or bipolar affective disorder (depressive episode).
* Treatment-Resistant Depression (TRD): inadequate response to ≥2 adequate antidepressant trials in the current episode (per clinician judgment or ATHF if available).
* Baseline assessments available: MADRS within ≤7 days before first TMS session and baseline Sensation Seeking Scale (SSS) prior to or at treatment initiation.
* Capacity to provide informed consent and ability to complete study questionnaires in the site language.
Exclusion Criteria:
* Contraindications to TMS (per device labeling/clinical standards): any ferromagnetic or electronic intracranial/cranial implants, cochlear implant, deep brain stimulator, medication pump near coil, skull defect, or other conditions deemed unsafe by the treating clinician.
* History of seizure/epilepsy (except single, clearly provoked event), current epileptiform disorder, or significant neurological disease lowering seizure threshold (e.g., recent stroke, brain tumor, active TBI with persistent sequelae, active CNS infection).
* Moderate-to-severe substance use disorder within the past 3 months (excluding nicotine/caffeine), per clinician assessment.
* Imminent suicide risk requiring a higher level of care (e.g., active plan/intent) at screening.
* Concurrent acute ECT or investigational device/drug during the TMS acute course (participation allowed if such treatments are not initiated during the observation window).
* Any condition that, in the judgment of the treating clinician or PI, would preclude safe TMS delivery or reliable outcome measurement (e.g., severe cognitive impairment preventing valid MADRS/SSS completion).
Source: ClinicalTrials.gov (NCT07889739). StuddyBuddy aggregates publicly available trial information.