Accelerated intermittent vs continuous theta-burst stimulation for treatment-resistant depression
Comparison of the Efficacy of Accelerated Intermittent Theta Burst Stimulation and Accelerated Continuous Theta Burst Stimulation in Patients With Treatment-Resistant Depression
This trial will test whether two accelerated theta-burst magnetic stimulation approaches—intermittent (iTBS) and continuous (cTBS)—work better for adults with treatment-resistant depression.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Ataturk University Academic / other |
| Locations | 1 site (Erzurum) |
| Trial ID | NCT07264452 on ClinicalTrials.gov |
What this trial studies
This interventional study compares accelerated unilateral intermittent TBS (iTBS) and continuous TBS (cTBS) delivered with a figure-eight coil in adults with treatment-resistant major depressive disorder. Participants meet strict inclusion criteria (ages 18–65, right-handed, HDRS ≥20, MADRS ≥20, and failure of at least two antidepressant trials) and undertake an intensive two-week treatment course with multiple daily sessions followed by a 12-week follow-up. The study measures changes in depressive symptoms, suicidal thoughts, anxiety, sleep disturbances, cognitive performance, and overall functioning. The protocol builds on TBS methods designed to increase stimulation dose and targeting precision to induce lasting neuroplastic changes.
Who should consider this trial
Good fit: Ideal candidates are right-handed adults aged 18–65 with DSM-5 major depressive disorder who have not responded to at least two adequate antidepressant trials and have HDRS and MADRS scores of 20 or higher while on a stable medication dose for at least four weeks.
Not a fit: Patients with major neurological, metabolic, or systemic illnesses that affect cognition, implanted electronic or intracranial devices, intellectual disability, or those outside the 18–65 age range are excluded and unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the study could identify a faster, more effective nonpharmacologic treatment option that reduces depressive symptoms and suicidal thoughts in people with treatment-resistant depression.
How similar studies have performed: Previous randomized and open-label studies support the antidepressant effects of iTBS and show promise for cTBS and accelerated TBS protocols, but direct head-to-head comparisons remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. 18 to 65 years old 2. Patients diagnosed with Major Depressive Disorder according to DSM 5 and the severity of their illness 3. Scoring 7 points or more on the Maudsley staging method 4. Having depression unresponsive to 2 different antidepressants 5. No clinical mental retardation 6. Agree to participate in the study 7. Hamilton Depression Rating Scale-17 \[HDRS\] score of 20 or higher 8. Montgomery Asberg Depression Rating Scale \[MADRS\] score of 20 or above 9. Being right hand dominant 10. Having used the same antidepressant at the same dose for the last 4 weeks Exclusion Criteria: 1. 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) 2. Having a foreign body such as a pacemaker, intracranial implant that can magnetically interact 3. Hearing and visual impairments that prevent communication 4. Unstable or acute medical conditions 5. Pregnancy or breastfeeding 6. Having a primary psychiatric disorder other than major depressive disorder 7. Being diagnosed with severe MDD with psychotic features
Where this trial is running
Erzurum
- Ataturk University — Erzurum, Turkey (Türkiye) (Recruiting)
Study contacts
- Principal investigator: Omer Faruk UYGUR, Associate professor doctor — Ataturk University
- Study coordinator: Mahmut Balamur, research assistant doctor
- Email: m.balamur5@gmail.com
- Phone: +905350705623
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.