NCT06371352Recruiting
Effect of Intermittent and Continuous Theta Burst Stimulation on Sleep, Daytime Sleepiness, and Fatigue in Depression
Effect of Intermittent and Continuous Theta Burst Stimulation on Sleep Quality, Sleep Propensity, Daytime Sleepiness, and Fatigue in Depression
Source: ClinicalTrials.gov · Last updated 15 Oct 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 90 (estimated)
- First submitted
- 8 Apr 2024
- Start date
- 15 May 2024
- Primary completion date
- Dec 2026
- Lead sponsor
- Jakub Antczak
- Diseases
- Depression, Bipolar disorder
- NCT number
- NCT06371352
What you commit to
- Study type: Interventional
- Planned participants: 90
- From 15 May 2024 to the primary completion date, Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Suicidal ideations and/or attempts within three months prior to inclusion
Other illness
- Contraindications to transcranial magnetic stimulation, including ferromagnetic elements in head, pregnancy and epilepsy
Other
- Psychotic symptoms at the time of inclusion
Who the study is looking for
- 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
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Institute of Psychiatry and Neurology Coordinator of this site? Confirm its status | Warsaw | Poland | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.