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Accelerated iTBS for Major Depression (AIM-D)

21. maj 2026 opdateret af: Merve Rana Altunel, Istanbul University - Cerrahpasa

Investigation of the Relationship Between Changes in Neurobiological Biomarkers After Accelerated Transcranial Magnetic Stimulation Treatment and Treatment Response in Patients With Major Depressive Disorder

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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Major depressive disorder (MDD) is a highly prevalent and disabling psychiatric disorder. A substantial proportion of patients do not achieve sufficient improvement with conventional antidepressant treatments, resulting in treatment-resistant or difficult-to-treat depression. Noninvasive neuromodulation approaches such as transcranial magnetic stimulation (TMS) have emerged as effective alternatives for these patients. Accelerated intermittent theta burst stimulation (iTBS), delivered in multiple daily sessions over a short period, may provide faster clinical improvement compared with conventional protocols.

This prospective single-arm interventional study aims to evaluate the clinical efficacy and biological correlates of accelerated bilateral dorsomedial prefrontal cortex (DMPFC) iTBS in adults with MDD who have shown inadequate response to at least one adequate antidepressant treatment trial.

Participants aged 18 to 65 years will receive accelerated bilateral DMPFC iTBS for five consecutive days, with four sessions per day (20 total sessions). Participants demonstrating partial clinical improvement without remission after 20 sessions may receive an additional 10 sessions according to clinical evaluation.

Clinical assessments will be performed at baseline, during treatment, at the end of treatment, and at one-month follow-up. Outcome measures include Hamilton Depression Rating Scale (HAM-D), Beck Depression Inventory, Beck Anxiety Inventory, suicidal ideation measures, self-rated depressive symptom scales, and Clinical Global Impression ratings.

Blood samples will be collected at baseline and after treatment to evaluate neurobiological biomarkers, including cortisol, adrenocorticotropic hormone (ACTH), brain-derived neurotrophic factor (BDNF), interleukin-1 beta (IL-1β), interleukin-6 (IL-6), tumor necrosis factor-alpha (TNF-α), and C-reactive protein (CRP).

The primary objective is to determine treatment response based on reduction in depressive symptom severity. Secondary objectives are to examine biomarker changes associated with treatment, identify predictors of response, and explore the relationship between early symptom improvement and final clinical outcomes.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

35

Fase

  • Ikke anvendelig

Kontakter og lokationer

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Studiekontakt

Studiesteder

  • Tyrkiet (Türkiye)
      • Istanbul, Tyrkiet (Türkiye), 34000
        • Rekruttering
        • Istanbul University - Cerrahpasa
        • Kontakt:
        • Kontakt:
        • Ledende efterforsker:
          • Merve Rana Altunel Ülkü, MD
        • Underforsker:
          • Cana Aksoy Poyraz, Prof. Dr.

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

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Ingen

Beskrivelse

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • Active suicidal crisis, severe agitation, or inability to comply with study procedures

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Accelerated iTBS
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.
Enhed: Accelerated Intermittent Theta Burst Stimulation (iTBS)
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Hamilton Depression Rating Scale (HAM-D) Score
Tidsramme: Baseline, within 3 days after completion of treatment and 1-month follow-up
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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Treatment Response Rate Based on HAM-D
Tidsramme: within 3 days after completion of treatment
Proportion of participants achieving ≥50% reduction in HAM-D score from baseline.
within 3 days after completion of treatment
Remission Rate Based on HAM-D
Tidsramme: Within 3 days after completion of treatment
Proportion of participants achieving remission defined as HAM-D score ≤7.
Within 3 days after completion of treatment
Sustained Treatment Response at 1-Month Follow-Up
Tidsramme: 1 month after treatment completion
Proportion of participants maintaining ≥50% reduction in HAM-D score at 1-month follow-up.
1 month after treatment completion
Sustained Remission at 1-Month Follow-Up
Tidsramme: 1 month after treatment completion
Proportion of participants maintaining remission, defined as HAM-D score ≤7, at 1-month follow-up.
1 month after treatment completion
Change in Serum Cortisol and ACTH Levels
Tidsramme: Baseline, within 3 days after completion of treatment and 1-month follow-up
Change in serum cortisol and adrenocorticotropic hormone (ACTH) levels following treatment.
Baseline, within 3 days after completion of treatment and 1-month follow-up
Change in Serum BDNF Levels
Tidsramme: Baseline, within 3 days after completion of treatment, and 1-month follow-up
Change in serum brain-derived neurotrophic factor (BDNF) levels following treatment.
Baseline, within 3 days after completion of treatment, and 1-month follow-up
Change in Inflammatory Biomarkers
Tidsramme: Baseline, within 3 days after completion of treatment, and 1-month follow-up
Change in serum IL-1β, IL-6, TNF-α, and C-reactive protein (CRP) levels following treatment.
Baseline, within 3 days after completion of treatment, and 1-month follow-up
Change in Beck Depression Inventory (BDI) Score
Tidsramme: Baseline, within 3 days after completion of treatment, and 1-month follow-up
Change in depressive symptom severity measured by the Beck Depression Inventory(BDI). Scores range from 0 to 63, with higher scores indicating greater depressive symptom severity.
Baseline, within 3 days after completion of treatment, and 1-month follow-up
Change in Beck Anxiety Inventory (BAI) Score
Tidsramme: Baseline, end of treatment, and 1-month follow-up
Change in anxiety symptom severity measured by the Beck Anxiety Inventory (BAI). Scores range from 0 to 63, with higher scores indicating greater anxiety severity.
Baseline, end of treatment, and 1-month follow-up
Change in Clinical Global Impression (CGI) Score
Tidsramme: Baseline, within 3 days after completion of treatment and 1-month follow-up
The scale includes three clinician-rated dimensions assessing illness severity (1-7), clinical improvement (1-7), and side effect severity (1-4).
Baseline, within 3 days after completion of treatment and 1-month follow-up

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Istanbul University - Cerrahpasa

Efterforskere

  • Studiestol: Cana Aksoy Poyraz, Prof. Dr., Istanbul University - Cerrahpasa

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

8. marts 2026

Primær færdiggørelse (Anslået)

1. december 2026

Studieafslutning (Anslået)

31. december 2026

Datoer for studieregistrering

Først indsendt

30. april 2026

Først indsendt, der opfyldte QC-kriterier

21. maj 2026

Først opslået (Faktiske)

22. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

22. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

21. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • E-24687260-604.01-1433619
  • TTU-2025-38714 (Andet bevillings-/finansieringsnummer: IU-Cerrahpasa Scientific Research Projects Unit)

Plan for individuelle deltagerdata (IPD)

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IPD-planbeskrivelse

Individual participant data will not be publicly shared due to institutional and ethical considerations.

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