protocolSection identificationModule nctId: NCT06372834, orgStudyIdInfo id: B202205178, briefTitle: Adjuvant Accelerated piTBS for Reducing Suicidal Ideation in TRD Patients: A Randomized, Sham-controlled Trial, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-11-07, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Tri-Service General Hospital, class: OTHER, descriptionModule briefSummary: In this double-blind, randomized, sham-controlled trial, we aimed to examine the effect of accelerated piTBS on suicide risk in a group of treatment-resistant patients with MDD (i.e., TRD), using an extensive suicide assessment scale the primary outcome. We hypothesized that this intensified treatment protocol would be safe in TRD patients with suicide ideations and would result in significant decreases in suicide risk in the active treatment condition as compared to the sham condition., conditionsModule conditions: Major Depressive Disorder, conditions: Treatment-Resistant Depression, conditions: Suicide Ideations, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: piTBS being delivered using the Magstim Rapid2 stimulator, outcomesModule primaryOutcomes measure: The change over time in the score of Beck Scale for Suicide Ideation (BSS) (from baseline to the timepoints at 1 week after piTBS, at the end of piTBS, and at 1, 2, and 4 weeks after piTBS)., secondaryOutcomes measure: The change over time in the score of Snaith-Hamilton Pleasure Scale (SHAPS) (from baseline to the timepoints at 1 week after piTBS, at the end of piTBS, and at 1, 2, and 4 weeks after piTBS)., secondaryOutcomes measure: The change over time in the score of Beck Hopelessness Scale (BHS) (from baseline to the timepoints at 1 week after piTBS, at the end of piTBS, and at 1, 2, and 4 weeks after piTBS)., secondaryOutcomes measure: The change over time in the score of Montgomery-Å sberg Depression Rating Scale (MADRS) (from baseline to the timepoints at 1 week after piTBS, at the end of piTBS, and at 1, 2, and 4 weeks after piTBS)., secondaryOutcomes measure: The change over time in the score of 17-item Hamilton Depression Rating Scale (HDRS) (from baseline to the timepoints at 1 week after piTBS, at the end of piTBS, and at 1, 2, and 4 weeks after piTBS)., secondaryOutcomes measure: The change over time in the score of Hamilton Anxiety Rating Scale (HAM-A) (from baseline to the timepoints at 1 week after piTBS, at the end of piTBS, and at 1, 2, and 4 weeks after piTBS)., secondaryOutcomes measure: The change over time in the score of Young Mania Rating Scale (YMRS) (from baseline to the timepoints at 1 week after piTBS, at the end of piTBS, and at 1, 2, and 4 weeks after piTBS)., secondaryOutcomes measure: The changes over time in the results of Wisconsin Card Sorting Test (WCST) (from baseline to the timepoint at the end of piTBS)., secondaryOutcomes measure: The changes over time in the results of Color Trails Test (CTT) (from baseline to the timepoint at the end of piTBS)., secondaryOutcomes measure: The changes over time in the results of Stroop Color Word Test (SCWT) (from baseline to the timepoint at the end of piTBS)., secondaryOutcomes measure: The changes over time in the results of indices of heart rate variability (HRV) (from baseline to the timepoint at the end of piTBS) and the HRV indices during each piTBS session., secondaryOutcomes measure: The changes over time in EEG absolute power and lag phase synchronization in the frontal electrodes in the delta, theta, alpha, beta and gamma range (from baseline to the end of piTBS)., secondaryOutcomes measure: The changes over time in high density near infrared spectroscopy (from baseline to the end of piTBS)., secondaryOutcomes measure: The changes over time in the results of Digit Symbol Substitution Test (DSST) (from baseline to the timepoint at the end of piTBS)., eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Tri-service general hospital, status: RECRUITING, city: Taipei, zip: 114, country: Taiwan, contacts name: Hsin-An Chang, M.D., role: CONTACT, phone: 011-886-2-8792-3311, phoneExt: 17389, email: chang.ha@mail.ndmctsgh.edu.tw, contacts name: Hsin-An Chang, M.D., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 25.04776, lon: 121.53185, hasResults: False