Actively Recruiting
Comparison of Accelerated Intermittent and Continuous Theta Burst Stimulation for Treatment-Resistant Depression
Led by Ataturk University · Updated on 2025-12-04
60
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying treatment-resistant depression (TRD), a form of major depressive disorder that does not improve after trying at least two different antidepressant treatments. This research compares two types of theta burst stimulation (TBS), a form of repetitive transcranial magnetic stimulation (rTMS), to see how well they reduce depression, suicidal thoughts, anxiety, sleep problems, and improve cognitive function and overall daily functioning. The trial involves an intensive two-week treatment period followed by a 12-week follow-up. Participants will be randomly assigned to one of two groups. One group will receive 50 sessions of intermittent theta burst stimulation (iTBS) applied to the left dorsolateral prefrontal cortex, and the other group will receive 50 sessions of continuous theta burst stimulation (cTBS) applied to the right dorsolateral prefrontal cortex. Treatments consist of five sessions per day, five days a week for two weeks, with rest breaks between sessions. Both methods use a figure-of-eight coil and specific stimulation frequencies and intensities. Throughout the study, patients will continue their current antidepressant medications without changes. Clinical assessments will be done before, during, and after treatment at multiple time points up to 14 weeks to measure depression severity, anxiety, suicidal thoughts, sleep quality, cognitive abilities, and daily functioning. These evaluations use well-known scales like the Hamilton Depression Rating Scale, Montgomery-Asberg Depression Rating Scale, and others. The study monitors safety and treatment effects during the follow-up period.
CONDITIONS
Brief Title
Comparison of the Efficacy of Accelerated Intermittent Theta Burst Stimulation and Accelerated Continuous Theta Burst Stimulation in Patients With Treatment-Resistant Depression
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 to 65 years old
- Diagnosed with major depressive disorder according to DSM-5
- Scoring 7 or more on the Maudsley staging method
- Depression unresponsive to at least two different antidepressants
- No clinical mental retardation
- Agree to participate in the study
- Hamilton Depression Rating Scale-17 score of 20 or higher
- Montgomery Asberg Depression Rating Scale score of 20 or above
- Right-hand dominant
- Using the same antidepressant at the same dose for the last 4 weeks
You will not qualify if you...
- Diagnosed with neurological or metabolic diseases affecting cognitive functions (e.g., diabetes, cardiovascular disease, Parkinson's disease, multiple sclerosis, malignancies)
- Having implanted devices like pacemakers or intracranial implants that interact with magnets
- Hearing or visual impairments preventing communication
- Unstable or acute medical conditions
- Pregnancy or breastfeeding
- Having a primary psychiatric disorder other than major depressive disorder
- Diagnosed with severe major depressive disorder with psychotic features
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 2 weeks
Participants receive accelerated transcranial magnetic stimulation sessions using either intermittent theta burst stimulation (iTBS) to the left dorsolateral prefrontal cortex or continuous theta burst stimulation (cTBS) to the right dorsolateral prefrontal cortex.
5 sessions per day, 5 days a week
Duration - 12 weeks post-treatment
Participants are assessed for depressive symptoms, anxiety, sleep disturbances, cognitive function, and overall functioning at multiple time points after treatment ends.
Assessments at weeks 2, 4, 8, and 12 post-treatment
Trial Site Locations
Total: 1 location
1
Ataturk University
Erzurum, Turkey (Türkiye), 25240
Actively Recruiting
Research Team
M
Mahmut Balamur, research assistant doctor
O
Omer Faruk UYGUR, Associate professor doctor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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