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Accelerated iTBS for Major Depression (AIM-D)

21 maggio 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

35

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

  • Nome: Merve rANA Altunel Ülkü, MD
  • Numero di telefono: +90 506 303 10 68
  • Email: ranaltunel@gmail.com

Luoghi di studio

  • Turchia (Türkiye)
      • Istanbul, Turchia (Türkiye), 34000
        • Reclutamento
        • Istanbul University - Cerrahpasa
        • Contatto:
        • Contatto:
          • Cana Aksoy Poyraz, Prof. Dr.
          • Numero di telefono: +90 532 715 95 04
          • Email: aksoycana@gmail.com
        • Investigatore principale:
          • Merve Rana Altunel Ülkü, MD
        • Sub-investigatore:
          • Cana Aksoy Poyraz, Prof. Dr.

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Dispositivo: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Hamilton Depression Rating Scale (HAM-D) Score
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Treatment Response Rate Based on HAM-D
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Istanbul University - Cerrahpasa

Investigatori

  • Cattedra di studio: Cana Aksoy Poyraz, Prof. Dr., Istanbul University - Cerrahpasa

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

8 marzo 2026

Completamento primario (Stimato)

1 dicembre 2026

Completamento dello studio (Stimato)

31 dicembre 2026

Date di iscrizione allo studio

Primo inviato

30 aprile 2026

Primo inviato che soddisfa i criteri di controllo qualità

21 maggio 2026

Primo Inserito (Effettivo)

22 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

22 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

21 maggio 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • E-24687260-604.01-1433619
  • TTU-2025-38714 (Altro numero di sovvenzione/finanziamento: IU-Cerrahpasa Scientific Research Projects Unit)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

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

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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