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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).

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07889739). StuddyBuddy aggregates publicly available trial information.