Effect of Intermittent and Continuous Theta Burst Stimulation on Sleep, Daytime Sleepiness, and Fatigue in Depression
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorJakub Antczak
About this trial
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
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- iTBS
- cTBS
- Sham
Treatment groups
90 Participants
are divided into 3 treatment groupsSponsors and collaborators
Jakub Antczak
Lead sponsor
Jagiellonian University
Sponsor institution
Institute of Psychiatry and Neurology, Warsaw
Collaborator
Source ClinicalTrials.gov