Effect of Intermittent and Continuous Theta Burst Stimulation on Sleep, Daytime Sleepiness, and Fatigue in Depression
Launched by JAKUB ANTCZAK · Apr 12, 2024
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is exploring the effects of two types of brain stimulation—intermittent theta burst stimulation (iTBS) and continuous theta burst stimulation (cTBS)—on sleep problems, daytime sleepiness, and fatigue in people with depression. Both iTBS and cTBS are non-invasive treatments that use magnetic fields to stimulate areas of the brain. The study aims to compare these two methods to see if they can help improve symptoms like insomnia and tiredness in individuals diagnosed with major depression or bipolar disorder.
To participate in this study, individuals should be between the ages of 65 and 74 or 23 to 740, and must have a moderate to severe episode of depression without any psychotic symptoms. They should also have a score of five or more on the Athens Insomnia Scale, indicating they have sleep difficulties. Participants will not be able to join if they have certain health issues that would prevent safe use of brain stimulation or if they have experienced suicidal thoughts recently. Those who qualify will receive either one of the active treatments or a placebo, which means they might not know if they are getting the real treatment or not. This trial is currently recruiting participants, and it aims to provide valuable insights into how these new stimulation techniques can help improve the quality of life for individuals facing depression.
Gender
ALL
Eligibility 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
About Jakub Antczak
Jakub Antczak is a dedicated clinical trial sponsor committed to advancing medical research and improving patient outcomes through innovative trial design and execution. With a strong focus on ethical standards and regulatory compliance, Jakub Antczak collaborates with healthcare professionals and research institutions to facilitate the development of new therapies and treatments. His extensive experience in the clinical research field ensures that trials are conducted efficiently, with an emphasis on participant safety and data integrity. By fostering partnerships and leveraging cutting-edge methodologies, Jakub Antczak aims to contribute significantly to the evolving landscape of medical science.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Warsaw, , Poland
Patients applied
Trial Officials
Bogdan Stefanowski, MD
Principal Investigator
Institute of Psychiatry and Neurology
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported