protocolSection identificationModule nctId: NCT06345651, orgStudyIdInfo id: 2023-03, Version 7, briefTitle: Brain Oscillation-synchronized Stimulation of the Frontal Cortex in Major Depressive Disorder, acronym: BOSSFRONT2, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-09-01, primaryCompletionDateStruct date: 2025-08, completionDateStruct date: 2025-08, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: University Hospital Tuebingen, class: OTHER, descriptionModule briefSummary: Major depressive disorder (MDD) is a common severe psychiatric disease with enormous socioeconomic costs for the patient and society alike. Current pharmacological treatments are ineffective in a substantial fraction of patients and are accompanied by unwanted side effects. Using a novel non-invasive brain stimulation method to specifically target and modulate dysfunctional brain oscillations with high spatial and temporal precision this study will investigate the efficacy of EEG-triggered transcranial magnetic stimulation to alleviate de-pressive symptomatology in patients with MDD in a double-blind randomized controlled pilot clinical trial., conditionsModule conditions: Major Depressive Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The study is a single-site randomized standard TMS therapy-controlled double-blind paral-lel-group design clinical trial., primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, maskingDescription: In both conditions the identical setup is used consisting of Neuronavigation, EEG and TMS. Only in the experimental condition the treatment will be EEG-informed. In the control condition the treatment will be applied indepentently of the EEG signal., whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Transcranial Magnetic Stimulation, outcomesModule primaryOutcomes measure: Montgomery-Åsberg Depression Rating Scale (MADRS), secondaryOutcomes measure: MADRS (Montgomery-Åsberg Depression Rating Scale) 4 weeks after intervention, secondaryOutcomes measure: HDRS-17 (Hamilton Depression Rating Scale-17), secondaryOutcomes measure: BDI-2 (Beck Depression Inventory-2), secondaryOutcomes measure: IDS-30 (Inventory of depressive symptoms-30), secondaryOutcomes measure: Response Rate, secondaryOutcomes measure: Remission Rate, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University Hospital Tuebingen, status: RECRUITING, city: Tuebingen, state: Baden-Wuerttemberg, zip: 72076, country: Germany, contacts name: Anne Lieb, Dr., role: CONTACT, phone: +4970712980483, email: anne.lieb@uni-tuebingen.de, contacts name: Andreas J. Fallgatter, Prof., role: PRINCIPAL_INVESTIGATOR, contacts name: Ulf Ziemann, Prof., role: PRINCIPAL_INVESTIGATOR, contacts name: Julia Becker-Sadzio, Dr., role: SUB_INVESTIGATOR, contacts name: Anne Lieb, Dr., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.52266, lon: 9.05222, hasResults: False