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Accelerated iTBS for Major Depression (AIM-D)

21 de maio de 2026 atualizado por: 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.

Visão geral do estudo

Status

Recrutamento

Condições

Intervenção / Tratamento

Descrição detalhada

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 de estudo

Intervencional

Inscrição (Estimado)

35

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

  • Nome: Merve rANA Altunel Ülkü, MD
  • Número de telefone: +90 506 303 10 68
  • E-mail: ranaltunel@gmail.com

Locais de estudo

  • Turquia (Türkiye)
      • Istanbul, Turquia (Türkiye), 34000
        • Recrutamento
        • Istanbul University - Cerrahpasa
        • Contato:
        • Contato:
          • Cana Aksoy Poyraz, Prof. Dr.
          • Número de telefone: +90 532 715 95 04
          • E-mail: aksoycana@gmail.com
        • Investigador principal:
          • Merve Rana Altunel Ülkü, MD
        • Subinvestigador:
          • Cana Aksoy Poyraz, Prof. Dr.

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: N / D
  • Modelo Intervencional: Atribuição de grupo único
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
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.
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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Change in Hamilton Depression Rating Scale (HAM-D) Score
Prazo: 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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Treatment Response Rate Based on HAM-D
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Istanbul University - Cerrahpasa

Investigadores

  • Cadeira de estudo: Cana Aksoy Poyraz, Prof. Dr., Istanbul University - Cerrahpasa

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

8 de março de 2026

Conclusão Primária (Estimado)

1 de dezembro de 2026

Conclusão do estudo (Estimado)

31 de dezembro de 2026

Datas de inscrição no estudo

Enviado pela primeira vez

30 de abril de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

21 de maio de 2026

Primeira postagem (Real)

22 de maio de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

22 de maio de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

21 de maio de 2026

Última verificação

1 de maio de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • E-24687260-604.01-1433619
  • TTU-2025-38714 (Número de outro subsídio/financiamento: IU-Cerrahpasa Scientific Research Projects Unit)

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Descrição do plano IPD

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

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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