Effects of theta burst stimulation on sleep and fatigue in 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 study investigates the effects of intermittent theta-burst stimulation (iTBS) and continuous theta-burst stimulation (cTBS) on sleep quality, daytime sleepiness, and fatigue in patients with unipolar depression and bipolar disorder. Participants will receive either iTBS over the left dorsolateral prefrontal cortex or cTBS over the right dorsolateral prefrontal cortex, with a control group receiving sham stimulation. The study aims to assess the safety and therapeutic potential of these stimulation techniques in alleviating symptoms beyond mood improvement, specifically targeting insomnia and fatigue.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* severe or moderate depressive episode (according to international classification of diseases (ICD)-10) without psychotic symptoms at the time of inclusion
* Diagnosis of major depression (F33.1 or F33.2) or bipolar disorder (F31.3 or F31.4).
* The score of the Athens Insomnia Scale five or more
* Unchanged antidepressive pharmacotherapy at least one month prior to inclusion

Exclusion Criteria:

* Contraindications to transcranial magnetic stimulation, including ferromagnetic elements in head, pregnancy and epilepsy
* Psychotic symptoms at the time of inclusion
* Suicidal ideations and/or attempts within three months prior to inclusion

Where it's running

• Institute of Psychiatry and Neurology
  Warsaw, Poland Recruiting

Study contacts

• Principal investigator: Bogdan Stefanowski, MD — Institute of Psychiatry and Neurology
• Study coordinator: Bogdan Stefanowski, MD
• Email: bstefanowski@ipin.edu.pl
• Phone: +48 22 45 82 532

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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.