About this trial
In recent years, research on the effectiveness of transcranial magnetic stimulation (TMS) in patients with treatment-resistant depression (RTD) has been steadily increasing. The aim of this study was to examine the effectiveness of accelerated unilateral application of two different forms of theta burst stimulation (TBU), a variation of repetitive TMU (rTMS)-intermittent TBU (iTBU) and continuous TBU (cTBU)-in TDD patients. The study aimed to compare the advantages of iTBU and cTBU protocols on depression, suicidal thoughts, anxiety levels, sleep disturbances, cognitive performance, and overall functioning following a two-week intensive treatment period and a 12-week follow-up period.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
18 to 65 years old
Patients diagnosed with Major Depressive Disorder according to DSM 5 and the severity of their illness
Scoring 7 points or more on the Maudsley staging method
Having depression unresponsive to 2 different antidepressants
Disqualifiers
Diagnosed with a neurological or metabolic disease that affects cognitive functions (Systemic diseases such as diabetes mellitus, cardiovascular disease, cerebrovascular disease, chronic renal failure, Parkinson's disease, multiple sclerosis, polyneuropathy, inflammatory rheumatologic disease and malignancies)
Having a foreign body such as a pacemaker, intracranial implant that can magnetically interact
Hearing and visual impairments that prevent communication
Unstable or acute medical conditions
Trial design
Parallel
Treatments tested in this trial
Transcranial Magnetic Stimulation with figure-eight coil
DeviceA total of 50 sessions will be administered to at least 30 patients, five sessions per day, five days a week for two weeks. There will be at least a 30-minute rest period between each session. One session for Group A involves a 5 Hz frequency intermittent theta burst stimulation (iTBS) protocol applied to the left DLPFC at 90-110% motor threshold.
Transcranial Magnetic Stimulation with figure-eight coil
DeviceThe other patient group (Group B), consisting of at least 30 individuals, will receive 5 sessions per day, 5 days a week, for 2 weeks, for a total of 50 sessions. There will be at least a 30-minute rest period between each session. Group B will receive a 5 Hz, continuous theta burst stimulation (cTBS) protocol to the right DLPFC at 80% motor threshold.
Treatment groups
Trial outcomes
Primary outcomes
Depression severity
The Montgomery-Asberg Depression Rating Scale. The minimum and maximum scores are 0-60. Higher scores mean a worse outcome.
Depression severity
The Hamilton Depression Rating Scale-17. The minimum and maximum scores are 0-51. Higher scores mean a worse outcome.
Secondary outcomes
Anxiety severity
Hamilton Anxiety Rating Scale. The minimum and maximum scores are 0-56. Higher scores mean a worse outcome.
Suicidal ideation score of The Hamilton Depression Rating Scale-17
Suicidal ideation score on the third question of the Hamilton Depression Rating Scale-17. The minimum and maximum scores are 0-4. Higher scores mean a worse outcome.
Suicidal ideation score of The Montgomery-Asberg Depression Rating Scale
Suicidal ideation score on the tenth question of the Montgomery-Asberg Depression Rating Scale. Minimum and maximum scores range from 0-6. Higher scores mean a worse outcome.
Insomnia Severity
It is measured with the Pittsburgh Sleep Quality Index (PSQI). The minimum and maximum scores are 0-21. Higher scores mean a worse outcome.
Sponsors and contacts
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