Clinical trial NCT06371352: Effect of Intermittent and Continuous Theta Burst Stimulation on Sleep, Daytime Sleepiness, and Fatigue in Depression
Official title: Effect of Intermittent and Continuous Theta Burst Stimulation on Sleep Quality, Sleep Propensity, Daytime Sleepiness, and Fatigue in Depression
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Unipolar Depression
Bipolar Disorder
Keywords: Unipolar Depression
Bipolar Disorder
theta burst stimulation
sleep
sleepiness
fatigue
transcranial magnetic stimulation
Lead sponsor: Jagiellonian University
Sponsor class: OTHER
Collaborators: name: Institute of Psychiatry and Neurology, Warsaw
First posted: 2024-04-17
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, randomized, sham-controlled clinical trial in parallel design
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Beck Depression Inventory 2
timeFrame: Before intervention - four weeks after finishing intervention.
measure: Pittsburgh Sleep Quality Index
timeFrame: Before intervention - four weeks after finishing intervention.
Secondary outcomes:
measure: Brief Psychiatric Rating Scale
timeFrame: Before intervention - four weeks after finishing intervention.
measure: Epworth Sleepiness Scale
timeFrame: Before intervention - four weeks after finishing intervention.
measure: Fatigue Assessment Scale
timeFrame: Before intervention - four weeks after finishing intervention.
measure: Quality of Life in Depression Scale
timeFrame: Before intervention - four weeks after finishing intervention.
measure: Sleep propensity non-rapid eye movement 1 sleep stage
timeFrame: Through study completion, an average of 1 year
measure: Sleep propensity non-rapid eye movement 2 sleep stage
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Institute of Psychiatry and Neurology
Study officials:
affiliation: Institute of Psychiatry and Neurology
name: Bogdan Stefanowski, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Silber MH, Ancoli-Israel S, Bonnet MH, Chokroverty S, Grigg-Damberger MM, Hirshkowitz M, Kapen S, Keenan SA, Kryger MH, Penzel T, Pressman MR, Iber C. The visual scoring of sleep in adults. J Clin Sleep Med. 2007 Mar 15;3(2):121-31.