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Recruiting NCT06371352

Effect of Intermittent and Continuous Theta Burst Stimulation on Sleep, Daytime Sleepiness, and Fatigue in Depression

No phase Interventional Unipolar Depression Bipolar Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: iTBS, cTBS, Sham.
Who it may be relevant to
Registry conditions: Unipolar Depression, Bipolar Disorder. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Poland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Effect of Intermittent and Continuous Theta Burst Stimulation on Sleep Quality, Sleep Propensity, Daytime Sleepiness, and Fatigue in Depression

Overview

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

  • 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.

Primary outcome measures

  • Beck Depression Inventory 2 [Time frame: Before intervention - four weeks after finishing intervention.]
  • Pittsburgh Sleep Quality Index [Time frame: Before intervention - four weeks after finishing intervention.]
Secondary outcome measures (6)
  • Brief Psychiatric Rating Scale [Time frame: Before intervention - four weeks after finishing intervention.]
  • Epworth Sleepiness Scale [Time frame: Before intervention - four weeks after finishing intervention.]
  • Fatigue Assessment Scale [Time frame: Before intervention - four weeks after finishing intervention.]
  • Quality of Life in Depression Scale [Time frame: Before intervention - four weeks after finishing intervention.]
  • Sleep propensity non-rapid eye movement 1 sleep stage [Time frame: Through study completion, an average of 1 year]
  • Sleep propensity non-rapid eye movement 2 sleep stage [Time frame: Through study completion, an average of 1 year]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

Poland · 1 center
  • Institute of Psychiatry and Neurology — Warsaw

Publications

  • 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. PMID 17557422

Identifiers

NCT: NCT06371352 · JagiellonianU73

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗