Comparison of the Efficacy of Accelerated Intermittent Theta Burst Stimulation and Accelerated Continuous Theta Burst Stimulation in Patients With Treatment-Resistant Depression

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorAtaturk University

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Transcranial Magnetic Stimulation with figure-eight coil

    Device

    A 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

    Device

    The 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

60 Participants
are divided into 2 treatment groups
Group A: ItbsActive comparator 1 intervention
Group B: ctbsActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Depression severity

The Montgomery-Asberg Depression Rating Scale. The minimum and maximum scores are 0-60. Higher scores mean a worse outcome.

Time frame
pretreatment, 1 week, 2 weeks, 4 weeks, 6 weeks, 10 weeks and 14 weeks
2

Depression severity

The Hamilton Depression Rating Scale-17. The minimum and maximum scores are 0-51. Higher scores mean a worse outcome.

Time frame
pretreatment, 1 week, 2 weeks, 4 weeks, 6 weeks, 10 weeks and 14 weeks

Secondary outcomes

1

Anxiety severity

Hamilton Anxiety Rating Scale. The minimum and maximum scores are 0-56. Higher scores mean a worse outcome.

Time frame
pretreatment, 1 week, 2 weeks, 4 weeks, 6 weeks, 10 weeks and 14 weeks
2

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.

Time frame
pretreatment, 1 week, 2 weeks, 4 weeks, 6 weeks, 10 weeks and 14 weeks
3

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.

Time frame
pretreatment, 1 week, 2 weeks, 4 weeks, 6 weeks, 10 weeks and 14 weeks
4

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.

Time frame
pretreatment, 4 weeks, 10 weeks and 14 weeks

Other outcomes

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