Adjuvant Accelerated piTBS for Reducing Suicidal Ideation in TRD Patients
NCT06372834, Not applicable, Completed, Tri-Service General Hospital (TSGH)
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Adjuvant Accelerated piTBS for Reducing Suicidal Ideation in TRD Patients | ClinicalTrials.gov |
| NCT number | NCT06372834 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 100 participants, actual | ClinicalTrials.gov |
| Lead sponsor | Tri-Service General Hospital (TSGH) | ClinicalTrials.gov |
| Conditions | Major Depressive Disorder, Treatment-Resistant Depression, Suicide Ideations | ClinicalTrials.gov |
| Interventions | piTBS being delivered using the Magstim Rapid2 stimulator | ClinicalTrials.gov |
| First posted | 2024-04-18 | ClinicalTrials.gov |
| Last updated | 2025-05-13 | ClinicalTrials.gov |
Registered outcomes 14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | 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). | 6 weeks | BSS is a 21-item self-report instrument for detecting and measuring the current intensity of the patients' specific attitudes, behaviors, and plans to commit suicide during the past week. | ClinicalTrials.gov |
| Secondary | 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). | 6 weeks | SHAPS is a 14-item self-report questionnaire to assess subject's pleasure experience in the "last few days". It is rated from definitely agree to definitely disagree on a 4-point Likert scale (i.e., scoring from 1 to 4) and the total score ranges from 14 to 56. Higher scores indicate more severe anhedonia. | ClinicalTrials.gov |
| Secondary | 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). | 6 weeks | BHS is 20-item questionnaire measuring pessimism/hopelessness, a construct related to suicide ideations. | ClinicalTrials.gov |
| Secondary | 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). | 6 weeks | The Montgomery-Åsberg Depression Rating Scale (MADRS) is a ten-item tool to measure the severity of depressive episodes. Each item yields a score of 0 to 6; the overall score thus ranges from 0 to 60. Higher MADRS score indicates more severe depression. | ClinicalTrials.gov |
| Secondary | 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). | 6 weeks | The Hamilton Rating Scale for Depression is a 17-item instrument that was designed to measure frequency and intensity of depressive symptoms in individuals with major depressive disorder. Ratings are made using either a five- or a three-point scale, yielding total scores from 0 to 61. | ClinicalTrials.gov |
| Secondary | 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). | 6 weeks | The HAM-A was to measure the severity of anxiety symptoms, consisting of 14 items, each defined by a series of symptoms, and measures both psychic anxiety and somatic anxiety. Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56. | ClinicalTrials.gov |
| Secondary | 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). | 6 weeks | The YMRS is a scale to assess manic symptoms. The scale has 11 items and is based on the patient's subjective report of his or her clinical condition over the previous 48 hours. There are four items that are graded on a 0 to 8 scale (irritability, speech, thought content, and disruptive/aggressive behavior), while the remaining seven items are graded on a 0 to 4 scale. | ClinicalTrials.gov |
| Secondary | The changes over time in the results of Wisconsin Card Sorting Test (WCST) (from baseline to the timepoint at the end of piTBS). | 2 weeks | A neuropsychological test of "set-shifting", i.e. the ability to display flexibility in the face of changing schedules of reinforcement. | ClinicalTrials.gov |
| Secondary | The changes over time in the results of Color Trails Test (CTT) (from baseline to the timepoint at the end of piTBS). | 2 weeks | The CTT, a culture-neutral version of the Trail Making Test, was selected to measure sustained visual attention. The CTT consists of two parts (CTT-1 and CTT-2). The CTT-1 requires participants to connect a series of numbered circles that are randomly printed on a sheet of paper. In the CTT-2, numbered circles of 1 to 25 are shown twice (printed in pink and in yellow) randomly on a sheet of paper. Participants are asked to connect the numbers from 1 to 25 alternating between the two colors. | ClinicalTrials.gov |
| Secondary | The changes over time in the results of Stroop Color Word Test (SCWT) (from baseline to the timepoint at the end of piTBS). | 2 weeks | Stroop Color Word Test (SCWT), Chinese version; was administered to measure selective attention and cognitive flexibility. SCWT is composed of three parts, each lasting for 45 seconds. | ClinicalTrials.gov |
| Secondary | 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. | 2 weeks | HRV indices represent autonomic functioning. ECG electrodes were placed on bilateral arms just below the elbows, with a ground electrode placed just above the right wrist bone. For HRV indices measured at baseline and the end of piTBS, lead I electrocardiogram of each patient was taken for 5 min after sitting and having a rest for 20 min in a soundproof, dim-lighted room with thermostatic control. For HRV indices measured during each piTBS session, lead I electrocardiogram of each patient was taken for 11 min. The ECG signals were acquired, stored, pre-processed according to the recommended procedures and processed by an HRV analyser. The time domain of HRV is obtained: Standard deviation of NN intervals (SDNN). Power spectrum of HRV is quantified into the standard frequency-domain measurements including low-frequency power (LF, 0.04-0.15 Hz), high-frequency power (HF, 0.15- 0.40 Hz). | ClinicalTrials.gov |
| Secondary | 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). | 2 weeks | In a recliner in a dimly lit, electrically shielded room, patients' EEGs were recorded at baseline and at the end of piTBS by using the full-band DC-EEG system with 32 EEG Ag/AgCl electrodes in the extended 10-20 International placement. EEG will be collected with eye opened (5min) and closed (5min). Signals will be amplified in the dynamic input range of ± 140 mV at a resolution of 0.5 μV by using EEG amplifiers and stored for offline analyses. Eye or muscle artifacts were automatically detected and removed. | ClinicalTrials.gov |
| Secondary | The changes over time in high density near infrared spectroscopy (from baseline to the end of piTBS). | 2 weeks | Resting-state and cognitive-task protocol used for the functional near infrared spectroscopy (fNIRS) system to measure the relative changes in oxy Hb. Hemoglobin Hb changes will be measured during a resting state (for 3 min) and 2 different cognitive tasks (each for around 5 min): semantic verbal fluency task (SVFT) and a 2 back task. An SVFT involves generating as many words as possible within a certain time frame and hints at the semantic category of the words generated. The 2 back task is used to evaluate participants' working memory. | ClinicalTrials.gov |
| Secondary | The changes over time in the results of Digit Symbol Substitution Test (DSST) (from baseline to the timepoint at the end of piTBS). | 2 weeks | The Digit Symbol Substitution Test (DSST) is a performance-based test of cognitive performance tapping into processing speed, executive function, and attention. It has a 90-s test period and a score range from 0 to 133. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 7
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| 2-Back Task | Secondary outcome | ConductCognition |
| Card Sorting Test (Berg) | Secondary outcome | ConductCognition |
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
| Symbol Coding | Secondary outcome | ConductCognition |
| Trail Making Test A | Secondary outcome | ConductCognition |
| Trail Making Test B | Secondary outcome | ConductCognition |
| Verbal Fluency | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)