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RECRUITINGINTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

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.

Locations (1)

Institute of Psychiatry and Neurology
Warsaw, Poland