Effect of Intermittent and Continuous Theta Burst Stimulation on Sleep Quality, Sleep Propensity, Daytime Sleepiness, and Fatigue in Depression
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Unipolar Depression
- Sponsor
- Jakub Antczak
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- Pittsburgh Sleep Quality Index
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
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.
Detailed Description
Intermittent and continuous theta-burst stimulation (iTBS and cTBS respectively) are the newer modalities of conventional repetitive transcranial magnetic stimulation (rTMS) with documented noninferiority in improving mood in depressive disorders. The effect of both modalities on other significant depression symptoms has not been studied. In this feasibility study investigators aim primarily to assess the safety and therapeutic potential of iTBS over the left dorsolateral prefrontal cortex (lDLPFC) and cTBS over the right dorsolateral prefrontal cortex (rDLPFC) on sleep quality, sleep propensity, fatigue, and daytime sleepiness in patients with major and bipolar depression.
Investigators
Jakub Antczak
Clinical Professor
Jagiellonian University
Eligibility Criteria
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
Outcomes
Primary Outcomes
Pittsburgh Sleep Quality Index
Time Frame: Before intervention - four weeks after finishing intervention.
Pittsburgh Sleep Quality Index is a questionnaire to identify sleep disturbances. It consists of a combination of Likert-type and open-ended questions, which are later converted to scaled scores. Scores for each question range from 0 to 3, with higher scores indicating greater sleep disturbances. The minimum value of the total score is 0 and the maximum is 21 with higher scores meaning worse outcome. Change from the baseline to the measurement done after finishing intervention, to the measurement done two weeks after finishing intervention to the measurement done four weeks after finishing intervention.
Beck Depression Inventory 2
Time Frame: Before intervention - four weeks after finishing intervention.
Inventory consisting of 21 items measuring cognitive, affective, somatic, and vegetative symptoms of depression. Each item is scored from 0 to 3, with a higher score denoting more severe depression. Items are related to the criteria from the Diagnostic and Statistical Manual of Mental Disorders-IV. The minimum value of the total score is 0 and the maximum is 63 with higher scores meaning worse outcome. Change from the baseline to the measurement done after finishing intervention, to the measurement done two weeks after finishing intervention to the measurement done four weeks after finishing intervention.
Secondary Outcomes
- Sleep propensity non-rapid eye movement 2 sleep stage(Through study completion, an average of 1 year)
- Brief Psychiatric Rating Scale(Before intervention - four weeks after finishing intervention.)
- Epworth Sleepiness Scale(Before intervention - four weeks after finishing intervention.)
- Sleep propensity non-rapid eye movement 1 sleep stage(Through study completion, an average of 1 year)
- Quality of Life in Depression Scale(Before intervention - four weeks after finishing intervention.)
- Fatigue Assessment Scale(Before intervention - four weeks after finishing intervention.)