Right-sided 1-Hz Repetitive Transcranial Magnetic Stimulation (rTMS) Versus Left-sided Intermittent Theta Burst Stimulation (iTBS) in Patients With Depression
2 other identifiers
interventional
350
1 country
2
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Dec 2025
Longer than P75 for phase_4
2 active sites
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
First Submitted
Initial submission to the registry
June 10, 2025
CompletedFirst Posted
Study publicly available on registry
June 18, 2025
CompletedStudy Start
First participant enrolled
December 15, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2031
December 16, 2025
December 1, 2025
5 years
June 10, 2025
December 8, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
reduction in the MADRS-S score
reduction in the MADRS-S score from baseline to the end of treatment
6 weeks
Secondary Outcomes (10)
Stimulation site pain
15 minutes
CGI-I
6 weeks
Patient rate remission
6 weeks
Patient rated response
6 weeks
Self-rated EQ-5D-VAS
6 weeks
- +5 more secondary outcomes
Study Arms (2)
right-sided rTMS
EXPERIMENTALright-sided inhibitory 1 Hz repetitive transcranial magnetic stimulation
left-sided iTBS
ACTIVE COMPARATORleft-sided intermittent theta burst stimulation
Interventions
Repetitive Transcranial Magnetic Stimulation (rTMS) is a non-invasive brain stimulation technique that uses pulsed magnetic fields to activate or suppress specific brain regions. It is used to treat various conditions, including major depressive disorder, by inducing small electrical currents that stimulate nerve cells.
Intermittent theta-burst stimulation (iTBS) is a form of transcranial magnetic stimulation (TMS) used to modulate brain activity. It involves delivering brief bursts of magnetic pulses to specific brain regions, typically the left dorsolateral prefrontal cortex (DLPFC)
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- If the investigator judges one of the two treatment protocols inappropriate for the patient.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Region Örebro Countylead
- Uppsala County Council, Swedencollaborator
Study Sites (2)
Unit for Brainstimulation
Örebro, Sweden
Unit for Brainstimulation
Uppsala, Sweden
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Axel Nordenskjöld, MD, PhD
Region Örebro County, Örebro University
- PRINCIPAL INVESTIGATOR
Robert Bodén, MD, PhD
Uppsala University, Region Uppsala County
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 10, 2025
First Posted
June 18, 2025
Study Start
December 15, 2025
Primary Completion (Estimated)
December 31, 2030
Study Completion (Estimated)
December 31, 2031
Last Updated
December 16, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will not share
Data will be available from the corresponding author upon reasonabe request