Effect of Intermittent and Continuous Theta Burst Stimulation on Sleep, Daytime Sleepiness, and Fatigue in Depression
NCT ID: NCT06371352
Last Updated: 2024-10-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
90 participants
INTERVENTIONAL
2024-05-15
2027-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Efficacy and Biomarkers of Response of TBS in Treatment Resistant Depression
NCT04998773
Theta-Burst Stimulation for Bipolar Depression
NCT06370988
Theta-Burst Stimulation in Major Depressive Episodes With Mixed Characteristics.
NCT04123301
Continuous Theta Burst Stimulation as an add-on Treatment for Bipolar Depression
NCT03603561
Long-term Bilateral Theta Burst Stimulation for the Treatment of Major Depression
NCT01153139
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
iTBS over the left DLPFC
Active iTBS with intensity of 120% of the resting motor threshold recorded from the right first dorsal interosseus will be administered over the left DLPFC. Therapy will include 90 sessions (three sessions in each of 20 consecutive working days - four weeks in total). In every session 900 magnetic pulses will be elicited.
iTBS
Active iTBS over the left DLPFC to induce the long term potentiation of stimulated area.
cTBS over the right DLPFC
Active cTBS with intensity of 120% of the resting motor threshold recorded from the left first dorsal interosseus will be administered over the right DLPFC. Therapy will include 90 sessions (three sessions in each of 20 consecutive working days - four weeks in total). In every session 1200 magnetic pulses will be elicited.
cTBS
Active cTBS over the right DLPFC to induce the long term potentiation of stimulated area.
Sham stimulation
Active iTBS or cTBS will be administered over the left or right DLPFC respectively with sham coil. Therapy will include 90 sessions (three sessions in each of 20 consecutive working days - four weeks in total). In every session 900 or 1200 magnetic pulses will be elicited.
Sham
Sham iTBS or cTBS over the left or right DLPFC respectively for placebo.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
iTBS
Active iTBS over the left DLPFC to induce the long term potentiation of stimulated area.
cTBS
Active cTBS over the right DLPFC to induce the long term potentiation of stimulated area.
Sham
Sham iTBS or cTBS over the left or right DLPFC respectively for placebo.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* Psychotic symptoms at the time of inclusion
* Suicidal ideations and/or attempts within three months prior to inclusion
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Institute of Psychiatry and Neurology, Warsaw
OTHER
Jakub Antczak
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Jakub Antczak
Clinical Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Bogdan Stefanowski, MD
Role: PRINCIPAL_INVESTIGATOR
Institute of Psychiatry and Neurology
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Institute of Psychiatry and Neurology
Warsaw, , Poland
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
JagiellonianU73
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.