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

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 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.