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Right-sided 1-Hz Repetitive Transcranial Magnetic Stimulation (rTMS) Versus Left-sided Intermittent Theta Burst Stimulation (iTBS) in Patients With Depression

RecruitingPhase 4Ages 18 Years - anyAllRegion Örebro County
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In plain words

What the trial is, and whether it could suit you

Aim: The purpose of the study is to establish the non-inferiority of right-sided inhibitory 1 Hz stimulation compared to left-sided intermittent theta burst stimulation (iTBS) in unipolar and bipolar depression. Design: A national, non-inferiority, register-based, randomized trial, unmasked, with two treatment arms. Primary objective: The primary objective is to determine if right-sided inhibitory 1-Hz stimulation to dorsolateral prefrontal cortex (DLPFC) is non inferior to iTBS in treating unipolar and bipolar depression by measuring reduction in Montgomery-Åsberg Depression Rating Scale, self-assessed version (MADRS-S) from baseline to end of treatment. Secondary objectives: Include testing for differences in: * Observer rated response according to Clinical Global Impression Scale-Improvement (≥2 point reduction CGI). * Response to treatment (a decrease of 50% on MADRS-S) * Self-ra

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📋 Eligibility rules (as published)
Inclusion Criteria: * At least 18 years of age at the time of inclusion. * A clinical diagnosis of unipolar or bipolar depression according to ICD-10. * Acceptance of rTMS. * A Swedish personal identity number. * Capable of giving informed consent. Exclusion Criteria: • If the investigator judges one of the two treatment protocols inappropriate for the patient.
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What it tests

  • repetitive transcranial magnetic stimulation
  • intermittent theta burst stimulation
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Where

2 sites
Unit for Brainstimulation
Örebro, Sweden
Unit for Brainstimulation
Uppsala, Sweden
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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