Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
NCT06371352

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

Led by Jakub Antczak · Updated on 2024-10-15

90

Participants Needed

1

Research Sites

154 weeks

Total Duration

On this page

Sponsors

J

Jakub Antczak

Lead Sponsor

I

Institute of Psychiatry and Neurology, Warsaw

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Moderate or severe depressive episode without psychotic symptoms
  • Diagnosis of major depression (F33.1 or F33.2) or bipolar disorder (F31.3 or F31.4)
  • Athens Insomnia Scale score of five or more
  • Antidepressant medication unchanged for at least one month before joining the study
Not Eligible

You will not qualify if you...

  • Contraindications to transcranial magnetic stimulation such as ferromagnetic elements in the head, pregnancy, or epilepsy
  • Presence of psychotic symptoms at the time of joining
  • Suicidal thoughts or attempts within three months before joining the study

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Institute of Psychiatry and Neurology

Warsaw, Poland, 02957

Actively Recruiting

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Research Team

B

Bogdan Stefanowski, MD

CONTACT

J

Jakub Antczak, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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