Actively Recruiting

Phase 4
Age: 18Years +
All Genders
NCT07026461

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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.
Not Eligible

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

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