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

Condition(s) studied

Investigational drug(s) / intervention(s)

repetitive transcranial magnetic stimulation: 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: 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)

Study 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

Eligibility

Primary outcome measure(s)

• reduction in the MADRS-S score — 6 weeks
  reduction in the MADRS-S score from baseline to the end of treatment

Trial sites (2)

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