Unipolar Depression, Bipolar Disorder
Conditions
Keywords
Unipolar Depression, Bipolar Disorder, theta burst stimulation, sleep, sleepiness, fatigue, transcranial magnetic stimulation
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.
Interventions
DEVICEiTBS
Active iTBS over the left DLPFC to induce the long term potentiation of stimulated area.
DEVICEcTBS
Active cTBS over the right DLPFC to induce the long term potentiation of stimulated area.
DEVICESham
Sham iTBS or cTBS over the left or right DLPFC respectively for placebo.
Sponsors
Institute of Psychiatry and Neurology, Warsaw
Jakub Antczak
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Placebo intervention will be delivered with a sham-coil for magnetic stimulation, which looks identical and elicits similar sounds as the coil used for active stimulation, but induces only negligible magnetic field.
Intervention model description
Prospective, randomized, sham-controlled clinical trial in parallel design
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Beck Depression Inventory 2 | 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. |
| Pittsburgh Sleep Quality Index | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fatigue Assessment Scale | Before intervention - four weeks after finishing intervention. | A 10-item scale to assess the severity of fatigue. Each item is an expression describing the fatigue, such as: I am bored by fatigue or Mentally I feel exhausted. Each item is answered using a Likert-type scale ranging from 1 (never) to 5 (always). The minimum value of the total score is 10 and the maximum is 50 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. |
| Quality of Life in Depression Scale | Before intervention - four weeks after finishing intervention. | A 34-item, self-reported scale to assess the impact of depression on the quality of life. The scale is scored binomially with higher scores indicating a lower quality of life. The minimum value of the total score is 0 and the maximum is 34 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. |
| Brief Psychiatric Rating Scale | Before intervention - four weeks after finishing intervention. | An 18-item scale assessing negative symptoms, such as emotional withdrawal (e.g. withdrawal from relations), motor slowness and blunted affect. Each item is rated from 1 to 7 with 7-point Likert scaling, where 7 means the most severe disturbance. The minimum value of the total score is 18 and the maximum is 126 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. |
| Sleep propensity non-rapid eye movement 2 sleep stage | Through study completion, an average of 1 year | A 23-channel electroencephalography (EEG), 2-channel electrooculogram (EOG) and a chin electromyogram (EMG) recorded through 45 minutes in lying position with eyes closed. The recordings will then be divided into 30 second epochs. Each epoch will be assigned to particular sleep stage or wake, according to standards of sleep staging issued by the American Academy of Sleep Medicine \[Silber et al. 2007\]. The difference in the latency of non-rapid eye movement 2 sleep stage (the time from light off to the first epoch of the non-rapid eye movement 2 sleep stage) before and after intervention will be assessed. |
| Sleep propensity non-rapid eye movement 1 sleep stage | Through study completion, an average of 1 year | A 23-channel electroencephalography (EEG), 2-channel electrooculogram (EOG) and a chin electromyogram (EMG) recorded through 45 minutes in lying position with eyes closed. The recordings will then be divided into 30 second epochs. Each epoch will be assigned to particular sleep stage or wake, according to standards of sleep staging issued by the American Academy of Sleep Medicine \[Silber et al. 2007\]. The difference in the latency of non-rapid eye movement 1 sleep stage (the time from light off to the first epoch of the non-rapid eye movement 1 sleep stage) before and after intervention will be assessed. |
| Epworth Sleepiness Scale | Before intervention - four weeks after finishing intervention. | An eight-item scale. Each item refers to a situation such as driving a car or sitting quietly. The subject is asked to assess the chance of dosing in each situation, ranging from 0 (no chance) to 3 (dosing very likely). The minimum value of the total score is 0 and the maximum is 24 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. |
Countries
Poland
Contacts
Primary ContactBogdan Stefanowski, MD
Backup ContactJakub Antczak, MD
Outcome results
None listed