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Accelerated iTBS for Major Depression (AIM-D)

21. Mai 2026 aktualisiert von: 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.

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

35

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

  • Türkei (türkiye)
      • Istanbul, Türkei (türkiye), 34000
        • Rekrutierung
        • Istanbul University - Cerrahpasa
        • Kontakt:
        • Kontakt:
        • Hauptermittler:
          • Merve Rana Altunel Ülkü, MD
        • Unterermittler:
          • Cana Aksoy Poyraz, Prof. Dr.

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: N / A
  • Interventionsmodell: Einzelgruppenzuweisung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 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.
Gerät: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in Hamilton Depression Rating Scale (HAM-D) Score
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Treatment Response Rate Based on HAM-D
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Istanbul University - Cerrahpasa

Ermittler

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

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

8. März 2026

Primärer Abschluss (Geschätzt)

1. Dezember 2026

Studienabschluss (Geschätzt)

31. Dezember 2026

Studienanmeldedaten

Zuerst eingereicht

30. April 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

21. Mai 2026

Zuerst gepostet (Tatsächlich)

22. Mai 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

22. Mai 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

21. Mai 2026

Zuletzt verifiziert

1. Mai 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • E-24687260-604.01-1433619
  • TTU-2025-38714 (Andere Zuschuss-/Finanzierungsnummer: IU-Cerrahpasa Scientific Research Projects Unit)

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Beschreibung des IPD-Plans

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

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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