Overview
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
Eligibility
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.