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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Sweden
Unit for Brainstimulation
RECRUITING
Örebro
Unit for Brainstimulation
RECRUITING
Uppsala
Contact Information
Primary
Axel Nordenskjöld, MD,PhD
axel.nordenskjold@regionorebrolan.se
+46196021000
Backup
Cecilia Vestlund, MD
cecilia.vestlund@regionorebrolan.se
+46196021000
Time Frame
Start Date: 2025-12-15
Estimated Completion Date: 2031-12-31
Participants
Target number of participants: 350
Treatments
Experimental: right-sided rTMS
right-sided inhibitory 1 Hz repetitive transcranial magnetic stimulation
Active_comparator: left-sided iTBS
left-sided intermittent theta burst stimulation
Related Therapeutic Areas
Sponsors
Collaborators: Uppsala County Council, Sweden
Leads: Region Örebro County

This content was sourced from clinicaltrials.gov