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
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with unipolar or bipolar depression who accept magnetic stimulation treatment (rTMS). It compares two ways of giving the stimulation.
- Age
- 18 years or older
- Sex
- Women and men can both join.
- Disease stage
- A clinical diagnosis of unipolar or bipolar depression according to ICD-10.
Main reasons for not taking part
- The investigator judges one of the two treatment methods inappropriate for the person
- Cannot join without a Swedish personal identity number
- Cannot join if unable to give informed consent
- Cannot join if rTMS is not accepted
Read by machine on 9 November 2026.
Where in Sweden
- Unit for BrainstimulationÖrebro, SwedenTaking people
- Unit for BrainstimulationUppsala, SwedenTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
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.