Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
Healthy Volunteers
ID07264452

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

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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

Age: 18Years - 65Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

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

Follow-up

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

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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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