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

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

Conditions

• Depression - Major Depressive Disorder
• Depression Bipolar

Interventions

DEVICE

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.

DEVICE

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)

Sponsors & Collaborators

• Uppsala County Council, Sweden

  collaborator OTHER_GOV

• Region Örebro County

  lead OTHER

Principal Investigators

• Axel Nordenskjöld, MD, PhD · Region Örebro County, Örebro University

• Robert Bodén, MD, PhD · Uppsala University, Region Uppsala County

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-12-15

Primary Completion

2030-12-31

Completion

2031-12-31

Countries

• Sweden

Study Locations