Right-sided low-frequency (1-Hz) rTMS versus left-sided intermittent theta-burst stimulation for depression

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This national, register-based, randomized, unmasked non-inferiority trial in Sweden compares two rTMS protocols—right-sided inhibitory 1-Hz stimulation and left-sided intermittent theta-burst stimulation (iTBS)—delivered to the dorsolateral prefrontal cortex in adults with unipolar or bipolar depression. Participants are randomized to one of two treatment arms and receive a course of rTMS at brain stimulation units in Örebro or Uppsala. The primary outcome is change in self-rated Montgomery-Åsberg Depression Rating Scale (MADRS-S) from baseline to end of treatment, with secondary outcomes including clinician-rated CGI-Improvement, response defined as ≥50% reduction in MADRS-S, and health-related quality of life (EQ-5D VAS). The trial is phase 4 and aims to show whether the simpler right-sided 1-Hz approach is not worse than iTBS for reducing depressive symptoms.

Why it matters

Who can join: the full rules

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.

Where it's running

• Unit for Brainstimulation
  Örebro, Sweden Recruiting
• Unit for Brainstimulation
  Uppsala, Sweden Recruiting

Study contacts

• Principal investigator: Robert Bodén, MD, PhD — Uppsala University, Region Uppsala County
• Study coordinator: Axel Nordenskjöld, MD,PhD
• Email: axel.nordenskjold@regionorebrolan.se
• Phone: +46196021000

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.