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Effect of Intermittent and Continuous Theta Burst Stimulation on Sleep, Daytime Sleepiness, and Fatigue in Depression

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…

ClinicalTrials.gov IDNCT06371352

PhaseNA

Enrollment90

SponsorJakub Antczak

Age18 Years

SexALL

I'm interested View official listing

Conditions studied

Unipolar Depression, Bipolar Disorder

About this study

Interventions

Device: iTBS — Active iTBS over the left DLPFC to induce the long term potentiation of stimulated area.
Device: cTBS — Active cTBS over the right DLPFC to induce the long term potentiation of stimulated area.
Device: Sham — Sham iTBS or cTBS over the left or right DLPFC respectively for placebo.

Primary outcomes

Beck Depression Inventory 2 (Before intervention - four weeks after finishing intervention.)
Pittsburgh Sleep Quality Index (Before intervention - four weeks after finishing intervention.)

Eligibility information

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

Study locations

Institute of Psychiatry and Neurology, Warsaw, 02957 Poland

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.