NCT06371352 Effect of Intermittent and Continuous Theta Burst Stimulation on Sleep, Daytime Sleepiness, and Fatigue in Depression
| NCT ID | NCT06371352 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Jakub Antczak |
| Condition | Unipolar Depression |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2024-05-15 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 90 participants in total. It began in 2024-05-15 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Intermittent and continuous theta-burst stimulation (iTBS and cTBS respectively) are the newer modalities of transcranial magnetic stimulation with documented efficacy in treatment of depressed mood but with conflicting results regarding their efficacy in treatment of other symptoms of depression such as insomnia, daytime sleepiness and fatigue. This study will investigate the efficacy of iTBS over the left dorsolateral prefrontal cortex (DLPFC) and cTBS over the right DLPFC, compared to sham stimulation, in treatment of insomnia, daytime sleepiness and fatigue in depression.
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
Contact & Investigator
Bogdan Stefanowski, MD
PRINCIPAL INVESTIGATOR
Institute of Psychiatry and Neurology
Frequently Asked Questions
Who can join the NCT06371352 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Unipolar Depression. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06371352 currently recruiting?
Yes, NCT06371352 is actively recruiting participants. Contact the research team at bstefanowski@ipin.edu.pl for enrollment information.
Where is the NCT06371352 trial being conducted?
This trial is being conducted at Warsaw, Poland.
Who is sponsoring the NCT06371352 clinical trial?
NCT06371352 is sponsored by Jakub Antczak. The principal investigator is Bogdan Stefanowski, MD at Institute of Psychiatry and Neurology. The trial plans to enroll 90 participants.
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