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Taking people in SwedenPhase 4

Compares two magnetic brain stimulation methods in adults with depression

Tests two magnetic brain stimulation treatments in adults with depression or bipolar depression.

Plain-language title generated from the registry record
Registry title: Right-sided 1-Hz Repetitive Transcranial Magnetic Stimulation (rTMS) Versus Left-sided Intermittent Theta Burst Stimulation (iTBS) in Patients With Depression

Key facts

Where
Örebro and Uppsala, SwedenSee the 2 sites
Phase
Phase 4

Where in Sweden

  • Unit for BrainstimulationÖrebro, SwedenTaking people
  • Unit for BrainstimulationUppsala, SwedenTaking people

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  4. What happens if I want to stop?
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Trial details

Who runs it
Region Örebro County
Trial code
NCT07026461
Record updated
16 December 2025
Original description
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.Read full original descriptionShow less

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

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

Inclusion: 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: If the investigator judges one of the two treatment protocols inappropriate for the patient.

ClinicalTrials.gov NCT07026461