Using intermittent theta burst stimulation to maintain depression treatment

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 study involves a randomized, multi-center, open-label approach where patients with depression who previously responded to intermittent theta burst stimulation (iTBS) will receive this treatment as maintenance therapy. Participants will be divided into two groups based on the frequency of stimulation: one group will receive standard iTBS over a week, while the other will receive accelerated iTBS in one day. An interim analysis will be conducted after half of the patients have been treated to estimate the effect size.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* adult women and men aged 18 to 70 years with an ICD-10 diagnosis of a depressive episode of depressive disorder (F32), recurrent depressive disorder (F33), or bipolar disorder (F31)
* moderate or severe current episode prior to initial open iTBS treatment (HAMD-21 \>16 points)
* response to iTBS treatment (either reduction in HAMD score by 50% or score at the end of treatment \<11 points)
* no concomitant psychotic symptoms.
* no other relevant psychiatric disorder as assessed by the study physician
* residence in Germany and German speaking that allows understanding of the information provided
* patient is capable of giving consent

Exclusion Criteria:

* fulfillment of the general contraindications for TMS (electrical implants or metallic objects in the body such as pacemakers or insulin pumps).
* severe neurological diseases (e.g., cerebrovascular events, neurodegenerative diseases, epilepsy, malformations of the brain, severe head injury in the history)
* current harmful use or dependence on alcohol, amphetamines, cocaine, benzodiazepines, anticonvulsants, or opiates
* acute suicidality
* pregnancy
* current participation in another study

Where it's running

• Department of Psychiatry and Psychotherapy, University of Regensburg
  Regensburg, Germany Recruiting

Study contacts

• Principal investigator: Berthold Langguth, Prof. — University Hospital of Regensburg, Department of Psychiatry and Psychotherapy at the Bezirksklinikum
• Study coordinator: Martin Schecklmann, Prof.
• Email: martin.schecklmann@medbo.de
• Phone: +49-941-941-2054

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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.