Accelerated iTBS for Major Depression

NCT07603804 | Recruiting

• 2 other identifiers: E-24687260-604.01-1433619TTU-2025-38714
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

Major depressive disorder (MDD) is a common and disabling psychiatric condition, and many patients do not achieve adequate response to standard antidepressant treatments. Accelerated intermittent theta burst stimulation (iTBS) is a promising neuromodulation approach that may provide rapid antidepressant effects. This prospective interventional study aims to evaluate the clinical effectiveness of accelerated bilateral dorsomedial prefrontal cortex iTBS in patients with MDD and to investigate treatment-related changes in neurobiological biomarkers, including cortisol, ACTH, BDNF, IL-1β, IL-6, TNF-α, and CRP. Associations between biomarker changes and treatment response will also be examined.

Conditions

Major Depressive Disorder (MDD); Treatment Resistant Depression (TRD)

Keywords

Major Depressive Disorder; Treatment Resistant Depression; Depression; Transcranial Magnetic Stimulation; TMS; Intermittent Theta Burst Stimulation; iTBS; Accelerated TMS; Accelerated iTBS; Dorsomedial Prefrontal Cortex; Biomarkers; Neuroinflammation; BDNF; Cortisol; ACTH

Outcome Measures

Primary Outcomes (1)

• Change in Hamilton Depression Rating Scale (HAM-D) Score

  Change in depressive symptom severity measured by the 17-item Hamilton Depression Rating Scale (HAM-D-17). Scores range from 0 to 53, with higher scores indicating greater depression severity.

  Baseline, within 3 days after completion of treatment and 1-month follow-up

Secondary Outcomes (10)

• Treatment Response Rate Based on HAM-D

  within 3 days after completion of treatment

• Remission Rate Based on HAM-D

  Within 3 days after completion of treatment

• Sustained Treatment Response at 1-Month Follow-Up

  1 month after treatment completion

• Sustained Remission at 1-Month Follow-Up

  1 month after treatment completion

• Change in Serum Cortisol and ACTH Levels

  Baseline, within 3 days after completion of treatment and 1-month follow-up

Study Arms (1)

Accelerated iTBS

EXPERIMENTAL

Participants receive accelerated bilateral dorsomedial prefrontal cortex intermittent theta burst stimulation (iTBS) administered over five consecutive days, with four sessions per day (20 sessions total). Participants with partial clinical response may receive an additional 10 sessions.

Device: Accelerated Intermittent Theta Burst Stimulation (iTBS)

Interventions

Accelerated Intermittent Theta Burst Stimulation (iTBS) DEVICE

Accelerated intermittent theta burst stimulation (iTBS) is administered bilaterally to the dorsomedial prefrontal cortex using a double-cone coil, targeting the stimulation site based on anatomical landmarks. Treatment is delivered over five consecutive days with four sessions per day (total of 20 sessions). Each session consists of 600 pulses per hemisphere (1200 pulses total) at an intensity of 120% of the individual motor threshold. Participants with partial response may receive an additional 10 sessions.

Accelerated iTBS

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18 and 65 years
• Diagnosis of Major Depressive Disorder according to DSM-5 criteria
• Inadequate response to at least one adequate antidepressant treatment trial
• Hamilton Depression Rating Scale (HAM-D) score ≥14 at baseline
• Stable dose of antidepressant medication for at least 4 weeks prior to study entry
• Ability to provide written informed consent

You may not qualify if:

• History of bipolar disorder, schizophrenia, schizoaffective disorder, or psychotic depression
• Current substance use disorder
• Neurological disorders that may affect brain function (e.g., epilepsy, multiple sclerosis, dementia, Parkinson's disease)
• History of epileptic seizures
• Severe head trauma
• Presence of metal implants in the head or neck region
• Cochlear implants
• Cardiac pacemaker or implanted electronic devices
• History of deep brain stimulation or vagus nerve stimulation
• Previous neurosurgical procedures
• Pregnancy or breastfeeding
• Use of medications that may significantly affect neuroendocrine or inflammatory markers (e.g., corticosteroids, immunomodulators)
• Endocrine disorders affecting the hypothalamic-pituitary-adrenal axis (e.g., Cushing's syndrome, Addison's disease, thyroid disorders)
• Autoimmune diseases (e.g., systemic lupus erythematosus, rheumatoid arthritis, Hashimoto thyroiditis)
• Recent surgery or acute infection

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

Istanbul University - Cerrahpasa

Istanbul, 34000, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Depressive Disorder, Major; Depressive Disorder, Treatment-Resistant; Depression; Neuroinflammatory Diseases

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior; Nervous System Diseases; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Cana Aksoy Poyraz, Prof. Dr.

  Istanbul University - Cerrahpasa

  STUDY CHAIR

Central Study Contacts

Merve Rana Altunel Ülkü, MD

CONTACT

+90 506 303 10 68; ranaltunel@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Model Details: Single-arm, open-label interventional study in which all participants receive accelerated bilateral dorsomedial prefrontal cortex intermittent theta burst stimulation

Study Record Dates

• First Submitted: April 30, 2026
• First Posted: May 22, 2026
• Study Start: March 8, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 22, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)