Actively Recruiting
Right-sided 1-Hz Repetitive Transcranial Magnetic Stimulation (rTMS) Versus Left-sided Intermittent Theta Burst Stimulation (iTBS) in Patients With Depression
Led by Region Örebro County · Updated on 2025-12-16
350
Participants Needed
2
Research Sites
315 weeks
Total Duration
On this page
Sponsors
R
Region Örebro County
Lead Sponsor
U
Uppsala County Council, Sweden
Collaborating Sponsor
AI-Summary
What this Trial Is About
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-rated global health measured with the EuroQual-group 5 Dimensions Scale Visual Analogue Scale (EQ-5D-VAS). * Drop-out from treatment. * Stimulation site pain measured with the Numerical Rating Scales (NRS). * Adverse events. * Admission and suicides within 6 months. * New treatment course of rTMS or ECT within 6 months * Remission (score \< 11 on the MADRS-S) * Memory impairment measured with the Comprehensive Psychopathological Rating Scale (CPRS). Study population: Patients with unipolar or bipolar depression. Sample size: 350 patients. 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. Inclusion time: 2025-07-01 to 2029-01-01
CONDITIONS
Official Title
Right-sided 1-Hz Repetitive Transcranial Magnetic Stimulation (rTMS) Versus Left-sided Intermittent Theta Burst Stimulation (iTBS) in Patients With Depression
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 repetitive transcranial magnetic stimulation (rTMS).
- A Swedish personal identity number.
- Capable of giving informed consent.
You will not qualify if you...
- If the investigator judges one of the two treatment protocols inappropriate for the patient.
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Unit for Brainstimulation
Örebro, Sweden
Actively Recruiting
2
Unit for Brainstimulation
Uppsala, Sweden
Actively Recruiting
Research Team
A
Axel Nordenskjöld, MD,PhD
CONTACT
C
Cecilia Vestlund, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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