Effect of Theta-burst rTMS Therapy on the Clinical and Cognitive Symptoms of Patients With Therapy Resistant Depression and Response Prediction With Neuroimaging Methods.

Not Applicable

• Conditions: Transcranial Magnetic Stimulation, Repetitive; Depression - Major Depressive Disorder

• Registration Number: NCT07207239
• Lead Sponsor: Semmelweis University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-06-13
• Status Verified: 2025-09
• Study First Submitted: 2025-09-10
• Study First Submitted QC: 2025-09-28
• Last Update Submitted: 2025-09-28
• Study First Posted: 2025-10-03
• Last Update Posted: 2025-10-03
• Primary Completion: 2028-06-13
• Study Completion: 2028-06-13

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

1. diagnosis of depression
2. 18 years of age
3. Beck depression inventory score above 12 (screening)
4. MADRS score above 6 (baseline)

Exclusion Criteria

1. serious cognitive impairment
2. mental retardation
3. history of head injury with loss of consciousness for more than 1 hour
4. alcohol or drug abuse within the past 3 months

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Clinical symptoms	120 days	The primary outcome measures are the clinical symptoms of depression measured by a clinician with the Montgomery-Åsberg Depression Rating Scale.

Secondary Outcome Measures

Name	Time	Method
Neuroimaging characteristics	120 days	A secondary outcome measure is neuroimaging characteristics including the alpha peaks measured by EEG, the nonoscillatory component (1/f) calculated from resting EEG, and connectivity parameters measured by fMRI. These markers will play a part in response prediction.
Patient profile	120 days	The patient profile encompasses demographics and clinical characteristics, namely age, sex, level of education, history of other psychiatric conditions, comorbidities, and medications. Together with neuroimaging characteristics, these will be used for response prediction.
Cognitive functioning/Spatial working Memory	120 days	The test will be used measure spatial working memory. Memory span is the major outcome variable of this test (the longest number of elements correctly retraced). Higher values indicate better outcomes. Its minimum value is 0 and it has no theoretical maximum value.
Cognitive functioning/Executive function	120 days	The test will be used measure executive functioning. Number of mistakes is the major outcome variable of this test (mistakes arise when subjects fail to differentiate a distractor from the continuous task). Higher values indicate worse outcomes. Its minimum value is 0 and it has no theoretical maximum value.; Time Frame: 120 days
Cognitive functioning/reaction time	120 days	The test will be used measure executive functioning and reaction time. Average reaction time is the major outcome variable of this test. Higher values indicate worse outcomes.
Clinical symptoms based on self-report questionnaires	120 days	Beck depression inventories are to be used to monitor clinical symptoms of depression

Trial Locations

Locations (1)

Department of Psychiatry and Psychotherapy; 🇭🇺 Budapest, Pest County, Hungary

Department of Psychiatry and Psychotherapy

🇭🇺Budapest, Pest County, Hungary