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New treatment option for Unipolar Depression
Official title Effect of Intermittent and Continuous Theta Burst Stimulation on Sleep, Daytime Sleepiness, and Fatigue in Depression
ClinicalTrials.gov ID: NCT06371352
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- severe or moderate depressive episode (according to international classification of diseases (ICD)-10) without psychotic symptoms at the time of...
- 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
You likely can't join if
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Warsaw, Poland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Warsaw, Poland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.