Effect of Theta-burst rTMS Therapy on the Clinical and Cognitive Symptoms of Patients With Therapy Resistant Depression and Response Prediction With Neuroimaging Methods.
TMS-DEP-2024
1 other identifier
interventional
54
1 country
1
Brief Summary
The primary aim of the study is to find the combination of neuroimaging-related markers, demographics, and clinical characteristics that predict the response of patients with therapy-resistant depression to theta-burst rTMS treatment. The secondary aim is to monitor the cognitive effects of TMS therapy.
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 Jun 2025
Typical duration for not_applicable
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
June 13, 2025
CompletedFirst Submitted
Initial submission to the registry
September 10, 2025
CompletedFirst Posted
Study publicly available on registry
October 3, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 13, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 13, 2028
October 3, 2025
September 1, 2025
3 years
September 10, 2025
September 28, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Clinical symptoms
The primary outcome measures are the clinical symptoms of depression measured by a clinician with the Montgomery-Åsberg Depression Rating Scale.
120 days
Secondary Outcomes (6)
Neuroimaging characteristics
120 days
Patient profile
120 days
Cognitive functioning/Spatial working Memory
120 days
Cognitive functioning/Executive function
120 days
Cognitive functioning/reaction time
120 days
- +1 more secondary outcomes
Study Arms (1)
TB-rTMS
EXPERIMENTALInterventions
Theta-burst rTMS treatment stimulates the left Dorsolateral Prefrontal Cortex (DLPFC). The TBS parameters the investigators adopted follows the standard TBS protocols, with 3-pulse 50-Hz bursts given every 200 ms (at 5 Hz) and an intensity of 100% active motor threshold. The investigators plan to deliver 1800 stimuli to the left DLPFC daily in 9.5-minute blocks for four weeks.
Eligibility Criteria
You may qualify if:
- diagnosis of depression
- years of age
- Beck depression inventory score above 12 (screening)
- MADRS score above 6 (baseline)
You may not qualify if:
- serious cognitive impairment
- mental retardation
- history of head injury with loss of consciousness for more than 1 hour
- alcohol or drug abuse within the past 3 months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Psychiatry and Psychotherapy
Budapest, Pest County, 1083, Hungary
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
September 10, 2025
First Posted
October 3, 2025
Study Start
June 13, 2025
Primary Completion (Estimated)
June 13, 2028
Study Completion (Estimated)
June 13, 2028
Last Updated
October 3, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share