Effects of theta burst stimulation on sleep and fatigue in depression
Effect of Intermittent and Continuous Theta Burst Stimulation on Sleep Quality, Sleep Propensity, Daytime Sleepiness, and Fatigue in Depression
This study is testing if two types of brain stimulation can improve sleep and reduce tiredness in people with depression.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Jagiellonian University Academic / other |
| Locations | 1 site (Warsaw) |
| Trial ID | NCT06371352 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with major depression or bipolar disorder experiencing moderate to severe depressive episodes and significant insomnia.
Not a fit: Patients with psychotic symptoms, recent suicidal ideations, or contraindications to transcranial magnetic stimulation will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide new treatment options for improving sleep and reducing fatigue in patients with depression.
How similar studies have performed: While there is documented efficacy of theta-burst stimulation in improving mood, the specific effects on sleep and fatigue in depression are less explored, making this approach relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Warsaw
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.