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Recruiting NCT07026461

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

Phase IV Interventional Depression - Major Depressive Disorder Depression Bipolar

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: repetitive transcranial magnetic stimulation, intermittent theta burst stimulation.
Who it may be relevant to
Registry conditions: Depression - Major Depressive Disorder, Depression Bipolar. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Sweden
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Right-sided 1-Hz Repetitive Transcranial Magnetic Stimulation (rTMS) Versus Left-sided Intermittent Theta Burst Stimulation (iTBS) in Patients With Depression. -a Randomized Non-inferiority Trial

Overview

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

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)

Primary outcome measures

  • reduction in the MADRS-S score [Time frame: 6 weeks]
Secondary outcome measures (10)
  • Stimulation site pain [Time frame: 15 minutes]
  • CGI-I [Time frame: 6 weeks]
  • Patient rate remission [Time frame: 6 weeks]
  • Patient rated response [Time frame: 6 weeks]
  • Self-rated EQ-5D-VAS [Time frame: 6 weeks]
  • Drop-out [Time frame: 6 weeks]
  • Adverse events [Time frame: 6 weeks, follow-up at 6 months]
  • Self-rated EQ-5D-VAS at 6-month follow-up [Time frame: 6 months]
  • Self rated remission at 6-month follow-up [Time frame: 6 months]
  • Hospital admission [Time frame: 6 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Sweden · 2 centers
  • Unit for Brainstimulation — Örebro
  • Unit for Brainstimulation — Uppsala

Identifiers

NCT: NCT07026461 · 3.1 · CIV-ID 23-06-043272

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗