NCT Number: NCT07026461
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
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 4
Unit for Brainstimulation, Uppsala, Sweden
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: rTMS
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)
Time frame: 6 weeks
reduction in the MADRS-S score from baseline to the end of treatment
Time frame: 15 minutes
Stimulation site pain (self-rated by patients using Numerical Rating Scales (NRS)).
Time frame: 6 weeks
Professionally determined response according to Clinical Global Impression Scale-Improvement (CGI-I)
Time frame: 6 weeks
Remission (score < 11 on the MADRS-S)
Time frame: 6 weeks
Response to treatment (a decrease of 50% on MADRS-S)
Time frame: 6 weeks
Self-rated global health measured with the EuroQual-group 5 Dimensions Scale Visual Analogue Scale (EQ-5D-VAS)
Time frame: 6 weeks
Drop-out from treatment for any reason within 30 sessions
Time frame: 6 weeks, follow-up at 6 months
Adverse events including severe adverse events
Time frame: 6 months
Self-rated global health measured with the EQ-5D-VAS at 6-month follow-up
Time frame: 6 months
Self rated remission (score < 11 on MADRS-S) at 6-month follow-up
Time frame: 6 months
Hospital admissions for depression, hypomanic/manic switch, suicide attempts, and deaths including completed suicides within 6 months after randomization
Contact information is provided by the study sponsor or research team.
Axel Nordenskjöld, MD,PhD
CONTACT
Cecilia Vestlund, MD
CONTACT
Region Örebro County
Other
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
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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