Clinical trial NCT07026461: Right-sided 1-Hz Repetitive Transcranial Magnetic Stimulation (rTMS) Versus Left-sided Intermittent Theta Burst Stimulation (iTBS) in Patients With Depression
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Depression - Major Depressive Disorder
Depression Bipolar
Keywords: rtms
itbs
repetitive transcranial magnetic stimulation
randomized controlled trial
intermittent theta-burst stimulation
Lead sponsor: Region Örebro County
Sponsor class: OTHER
Collaborators: name: Akademiska University Hospital, Uppsala, Sweden
First posted: 2025-06-18
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: reduction in the MADRS-S score
timeFrame: 6 weeks
Secondary outcomes:
measure: Stimulation site pain
timeFrame: 15 minutes
measure: CGI-I
timeFrame: 6 weeks
measure: Patient rate remission
timeFrame: 6 weeks
measure: Patient rated response
timeFrame: 6 weeks
measure: Self-rated EQ-5D-VAS
timeFrame: 6 weeks
measure: Drop-out
timeFrame: 6 weeks
measure: Adverse events
timeFrame: 6 weeks, follow-up at 6 months
measure: Self-rated EQ-5D-VAS at 6-month follow-up
timeFrame: 6 months
measure: Self rated remission at 6-month follow-up
timeFrame: 6 months
measure: Hospital admission
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Region Örebro County, Örebro University
name: Axel Nordenskjöld, MD, PhD
role: STUDY_CHAIR
affiliation: Uppsala University, Region Uppsala County
name: Robert Bodén, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: