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
Trial Snapshot
- Phase
- Phase 4
- Status
- Recruiting
- Sponsor
- Enrollment
- 350
- Locations
- 2
- Primary Endpoint
- reduction in the MADRS-S score
Study Overview
Brief Summary
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •At least 18 years of age at the time of inclusion.
- •A clinical diagnosis of unipolar or bipolar depression according to ICD-
- •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.
Outcomes
Primary Outcomes
reduction in the MADRS-S score
Time Frame: 6 weeks
reduction in the MADRS-S score from baseline to the end of treatment
Secondary Outcomes
- Patient rated response(6 weeks)
- Stimulation site pain(15 minutes)
- CGI-I(6 weeks)
- Patient rate remission(6 weeks)
- Self-rated EQ-5D-VAS(6 weeks)
- Drop-out(6 weeks)
- Adverse events(6 weeks, follow-up at 6 months)
- Self-rated EQ-5D-VAS at 6-month follow-up(6 months)
- Self rated remission at 6-month follow-up(6 months)
- Hospital admission(6 months)