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

Region Örebro County

Status and phase: Enrolling; Phase 4

Conditions: Depression Bipolar; Depression - Major Depressive Disorder

Treatments: Device: intermittent theta burst stimulation; Device: repetitive transcranial magnetic stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT07026461

CIV-ID 23-06-043272 (Other Identifier)

3.1

Details and patient eligibility

About

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

Enrollment: 350 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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350 participants in 2 patient groups

right-sided rTMS

Experimental group

Description:

right-sided inhibitory 1 Hz repetitive transcranial magnetic stimulation

Treatment:

Device: repetitive transcranial magnetic stimulation

left-sided iTBS

Active Comparator group

Description:

left-sided intermittent theta burst stimulation

Treatment:

Device: intermittent theta burst stimulation