Comparison of the Efficacy of Accelerated Intermittent Theta Burst Stimulation and Accelerated Continuous Theta Burst Stimulation in Patients With Treatment-Resistant Depression
2 other identifiers
interventional
60
1 country
1
Brief Summary
In recent years, research on the effectiveness of transcranial magnetic stimulation (TMS) in patients with treatment-resistant depression (RTD) has been steadily increasing. The aim of this study was to examine the effectiveness of accelerated unilateral application of two different forms of theta burst stimulation (TBU), a variation of repetitive TMU (rTMS)-intermittent TBU (iTBU) and continuous TBU (cTBU)-in TDD patients. The study aimed to compare the advantages of iTBU and cTBU protocols on depression, suicidal thoughts, anxiety levels, sleep disturbances, cognitive performance, and overall functioning following a two-week intensive treatment period and a 12-week follow-up period.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2025
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 15, 2025
CompletedFirst Submitted
Initial submission to the registry
November 21, 2025
CompletedFirst Posted
Study publicly available on registry
December 4, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 15, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 15, 2027
December 4, 2025
December 1, 2025
1 year
November 21, 2025
December 2, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Depression severity
The Montgomery-Asberg Depression Rating Scale. The minimum and maximum scores are 0-60. Higher scores mean a worse outcome.
pretreatment, 1 week, 2 weeks, 4 weeks, 6 weeks, 10 weeks and 14 weeks
Depression severity
The Hamilton Depression Rating Scale-17. The minimum and maximum scores are 0-51. Higher scores mean a worse outcome.
pretreatment, 1 week, 2 weeks, 4 weeks, 6 weeks, 10 weeks and 14 weeks
Secondary Outcomes (7)
Anxiety severity
pretreatment, 1 week, 2 weeks, 4 weeks, 6 weeks, 10 weeks and 14 weeks
Suicidal ideation score of The Hamilton Depression Rating Scale-17
pretreatment, 1 week, 2 weeks, 4 weeks, 6 weeks, 10 weeks and 14 weeks
Suicidal ideation score of The Montgomery-Asberg Depression Rating Scale
pretreatment, 1 week, 2 weeks, 4 weeks, 6 weeks, 10 weeks and 14 weeks
Insomnia Severity
pretreatment, 4 weeks, 10 weeks and 14 weeks
Insomnia Severity
pretreatment, 2 weeks, 4 weeks, 6 weeks, 10 weeks and 14 weeks
- +2 more secondary outcomes
Study Arms (2)
Itbs
ACTIVE COMPARATORiTBS with eight digit coils to the left dorsolateral prefrontal cortex.
ctbs
ACTIVE COMPARATORcTBS with a figure-of-eight coil to the right dorsolateral prefrontal cortex.
Interventions
A total of 50 sessions will be administered to at least 30 patients, five sessions per day, five days a week for two weeks. There will be at least a 30-minute rest period between each session. One session for Group A involves a 5 Hz frequency intermittent theta burst stimulation (iTBS) protocol applied to the left DLPFC at 90-110% motor threshold.
Eligibility Criteria
You may qualify if:
- to 65 years old
- Patients diagnosed with Major Depressive Disorder according to DSM 5 and the severity of their illness
- Scoring 7 points or more on the Maudsley staging method
- Having depression unresponsive to 2 different antidepressants
- No clinical mental retardation
- Agree to participate in the study
- Hamilton Depression Rating Scale-17 \[HDRS\] score of 20 or higher
- Montgomery Asberg Depression Rating Scale \[MADRS\] score of 20 or above
- Being right hand dominant
- Having used the same antidepressant at the same dose for the last 4 weeks
You may not qualify if:
- Diagnosed with a neurological or metabolic disease that affects cognitive functions (Systemic diseases such as diabetes mellitus, cardiovascular disease, cerebrovascular disease, chronic renal failure, Parkinson's disease, multiple sclerosis, polyneuropathy, inflammatory rheumatologic disease and malignancies)
- Having a foreign body such as a pacemaker, intracranial implant that can magnetically interact
- Hearing and visual impairments that prevent communication
- Unstable or acute medical conditions
- Pregnancy or breastfeeding
- Having a primary psychiatric disorder other than major depressive disorder
- Being diagnosed with severe MDD with psychotic features
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ataturk University
Erzurum, 25240, Turkey (Türkiye)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Omer Faruk UYGUR, Associate professor doctor
Ataturk University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- associate professor
Study Record Dates
First Submitted
November 21, 2025
First Posted
December 4, 2025
Study Start
November 15, 2025
Primary Completion (Estimated)
November 15, 2026
Study Completion (Estimated)
January 15, 2027
Last Updated
December 4, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will not share