Adjuvant Accelerated piTBS for Reducing Suicidal Ideation in TRD Patients

NCT06372834 | Completed

• 1 other identifier: B202205178
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

In this double-blind, randomized, sham-controlled trial, the investigators 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. The investigators 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.

Conditions

Major Depressive Disorder; Treatment-Resistant Depression; Suicide Ideations

Keywords

Major Depressive Disorder; Treatment-Resistant Depression; Dorsolateral prefrontal cortex; rTMS; piTBS

Outcome Measures

Primary Outcomes (1)

• 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).

  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.

  6 weeks

Secondary Outcomes (13)

• 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

• 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

• 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 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 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

Study Arms (2)

piTBS (active, N=50)

EXPERIMENTAL

The piTBS sessions will be delivered using the Magstim Rapid2 stimulator (Magstim Company, Ltd, Whitland, Wales, UK, SA340HR) with a 70-mm air-cooled figure-eight coil (Magstim D70 Air film coil). The piTBS protocol consists of 3-pulse 50-Hz bursts given every 200 ms (at 5 Hz) for 2 s at 8-s intervals for 60 cycles. A 2-s train of piTBS will be repeated every 10 s for a total of 1800 pulses per session. The intensity of stimulation will be set at 90% resting motor threshold (RMT), as measured from the right first dorsal interosseous muscle by a handheld 700-mm figure-of-eight coil (Magstim D70 alpha coil). The Beam F3 method will be used for coil positioning to target the left dorsolateral prefrontal cortex. The piTBS protocol will be scheduled for 3 sessions per working day for 2 weeks (i.e., a total of 30 sessions over 2 weeks). Three sessions of the piTBS per day will be separated by at least 60 mins.

Device: piTBS being delivered using the Magstim Rapid2 stimulator

piTBS (sham, N=50)

SHAM COMPARATOR

The patients in the sham piTBS condition will receive the same piTBS regimen and exact positioning of the coil, but stimulations will be delivered using a commercial identical-looking figure-8 sham coil (Magstim D70 Air film sham coil) that can produce a similar sound and sensations but induce neither magnetic pulses nor current in the cortex.

Device: piTBS being delivered using the Magstim Rapid2 stimulator

Interventions

piTBS being delivered using the Magstim Rapid2 stimulator DEVICE

Magstim Rapid2 stimulator (Magstim Company, Ltd, Whitland, Wales, UK, SA340HR). See detail in arm/group descriptions regarding the intervention.

piTBS (active, N=50); piTBS (sham, N=50)

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects aged 20-65 years, met criteria for DSM-V major depressive disorder.
• A depression severity score of 18 or more on the 17-item Hamilton Rating Scale for Depression (HRSD-17) as well as a score of 1 or more on the item of the HDRS-17 (item 3).
• Meeting criteria for TRD defined as no clinical response to at least one adequate trial of one major class of antidepressants.
• Having been receiving stable antidepressant medications regimen for more than 4 weeks before enrollment and having their original medication regimen unchanged throughout the trial.

You may not qualify if:

• Having MDD with psychotic features, bipolar disorder, schizophrenia, organic brain syndrome or active substance (except for tobacco and coffeine) use disorder.
• Having previous intracranial surgery and ferromagnetic metallic implants in the head.
• History of brain abnormalities (e.g., brain neoplasms, arteriovenous malformations, meningitis, encephalitis, epilepsy, neurodegenerative disorders).
• Pregnancy at enrollment.
• History of treatment with electroconvulsive therapy (ECT) or no response to rTMS over the left DLPFC.
• Those who had attempted a suicide within six months from the screening date.
• Skin lesions on scalp at the area of coil application.
• In addition to those listed above, those who were deemed unsuitable for participating in this clinical trial by the medical judgment of the investigator due to other reasons (e.g., lack of competence to consent to research or any other contraindications to receiving rTMS).

Sponsors & Collaborators

• Tri-Service General Hospital: lead

Study Sites (1)

Tri-service general hospital

Taipei, 114, Taiwan

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Depressive Disorder, Treatment-Resistant

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Hsin-An Chang, MD

  Tri-Service General Hospital, National Defense Medical Center, Taipei, Taiwan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Psychiatrist, Department of Psychiatry

Study Record Dates

• First Submitted: April 15, 2024
• First Posted: April 18, 2024
• Study Start: March 29, 2023
• Primary Completion: December 20, 2024
• Study Completion: December 20, 2024
• Last Updated: May 13, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)